# EUR-Lex - 52014PC0558 - EN

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# 52014PC0558

**Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on veterinary medicinal products /* COM/2014/0558 final - 2014/0257 (COD) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

Justification and objectives

Work on a European legal framework for
veterinary medicinal products started in 1965 with the adoption of Directive
65/65/EEC,[1]
which required that marketing authorisations be issued before such products could
be placed on the market. Since then, numerous other directives and regulations
have been adopted to extend and refine the rules, and a harmonised framework
has gradually been established. In 2001, all the rules on production,
marketing, distribution and use were consolidated in a veterinary medicines
code (Directive 2001/82/EC);[2]
this was followed by Regulation (EC) No 726/2004.[3] These two acts regulate
the authorisation, manufacturing, marketing, distribution, pharmacovigilance
and use of veterinary medicinal products over their lifetime. The annex to the Directive
2001/82/EC specifies the data to be submitted in applications for marketing
authorisations. Among other things, the Regulation (EC) No 726/2004 lays down
the EU procedures applying to medicinal products for human and veterinary use
and establishes the European Medicines Agency (‘the Agency’).

In the course of the co-decision procedure for
its proposal for a regulation on residue limits of pharmacological active substances
in foodstuffs, the Commission submitted a declaration[4] recognising the
importance of problems linked to the availability of veterinary medicinal
products, the use of veterinary medicinal products in species for which they
are not authorised, and disproportionate regulatory burden hampering
innovation. The present proposal is the Commission’s follow-up to its
declaration.

Stakeholders and Member States have
expressed concern that the current legislation does not fully deliver a single
market in veterinary medicinal products and fails to meet the Union’s needs as
regards the regulation of medicines. In particular, the private and public
sectors have indicated the following areas for improvement:

· 
regulatory burden;

· 
the lack of availability of veterinary medicinal
products, especially for small markets such as that for bees; and

· 
the functioning of the internal market.

In this regard, it is important to recall
that needs of the veterinary sector differ substantially from those of the
human sector in relation to medicines. In particular, the drivers for
investment for the human and the veterinary medicines markets are different.
For example, in the veterinary sector there are many different animal species,
which creates both a fragmented market and the need for major investments in
order to extend the authorisation of medicines existing for one animal species
to another. Moreover, the price-setting mechanisms in the veterinary sector
follow a completely different logic. Consequently, prices for veterinary
medicines are typically substantially lower than for medicinal products for
human use. The size of the animal pharmaceutical industry is only a small
fraction of the size of the pharmaceutical industry for human medicines. It is
therefore considered appropriate to develop a regulatory framework addressing
the characteristics and specificities of the veterinary sector, which cannot be
considered as a model for the human medicines market.

The revision of Directive 2001/82/EC and
other legislation on veterinary medicinal products is in line with the
principles set out in the Commission’s 2013 and 2014 work programmes. The
proposal seeks to put in place, while safeguarding public health, animal
health, food safety and the environment, an up-to-date, proportionate body of legislation
tailored to the specificities of the veterinary sector, aiming in particular to:

· 
increase the availability of veterinary medicinal
products;

· 
reduce administrative burdens;

· 
stimulate competitiveness and innovation;

· 
improve the functioning of the internal market;
and

· 
address the public health risk of antimicrobial
resistance (AMR).

These objectives are not only
complementary, but also interlinked, as innovation will provide new and better
medicines to treat and prevent diseases in animals, while avoiding damage to
the environment.

The spread of AMR is a major threat to
public and animal health. In November 2011, the Commission launched a five-year
action plan,[5]
which seeks to mobilise all stakeholders in a joint effort to combat AMR; in
particular, Action 2 in the plan aims to strengthen the regulatory framework
for veterinary medicinal products. This proposal implements this action.

The Commission’s Communication on honeybee
health[6]
stresses the importance of proactively protecting bee health, while taking into
account the particularities of beekeeping, and acknowledges the limited
availability of medicines to treat the diseases that afflict bees. As regards
measures to increase availability, the Communication refers to the revision of
the legislation on veterinary medicinal products.

Legal basis

The legal bases for legislative measures on
animal health, which are essential to public and animal health, environmental
protection, trade and single market policy are:

–     Article 114 of the Treaty on the Functioning of the European
Union (TFEU), which provides for the establishment and functioning of the
internal market and the approximation of relevant legal, regulatory and
administrative provisions; and

–     Article 168(4)(b) TFEU, which covers measures in the
veterinary field directly aimed at protecting public health.

2.           RESULTS OF CONSULTATIONS
WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS

Better regulation of veterinary
pharmaceuticals: how to put in place a simpler legal framework, safeguarding
public and animal health while increasing the competitiveness of companies, a public consultation on the key issues of the envisaged legal
proposal, was launched on the Commission’s website on 13 April 2010 and was
available through the interactive policy-making (IPM) tool until 15 July
2010.[7]

The consultation and a study, An
assessment of the impact of the revision of veterinary pharmaceutical
legislation, formed the basis of an impact assessment carried out for the
Commission between November 2009 and June 2011.[8]

The Commission’s Impact Assessment Board
(IAB) released its final opinion in September 2013.

3.           LEGAL ELEMENTS OF THE
PROPOSAL

Chapter I:      Subject matter, scope and definitions

This part contains provisions on the scope
of the Regulation. It also sets out clear definitions reflecting the proposed
changes.

Chapter II:     Marketing authorisations — general provisions and
rules on applications

In the Union, only veterinary medicinal
products that meet standards of safety, quality and efficacy are authorised.
The proposal lays down rules for obtaining a marketing authorisation, specifying
that the product in question can be marketed for the approved indications only.
The indications are listed in the summary of product characteristics (SPC)
included in the terms of the marketing authorisation. Those terms also contain
a description of the product’s properties and the conditions attached to its
use. Before a marketing authorisation can be granted for a veterinary medicinal
product for food-producing species, the Commission has to establish a maximum
residue limit for the pharmacologically active substance it contains.

An applicant has to provide certain details
on the packaging and labelling of the medicine. The proposal introduces a major
simplification of the rules by reducing the compulsory information and introducing
harmonised pictograms and abbreviations. This should reduce translation and
packaging costs and encourage multilingual packages and labelling. Member
States will have a degree of flexibility as to the languages used.

In principle, applicants must prove the
quality, safety and efficacy of the veterinary medicinal product. In
exceptional circumstances (e.g. in emergencies) and where limited markets
are concerned, however, temporary authorisation may be granted without
comprehensive data in order to fill therapeutic gaps on the market.

This part of the proposal also includes
provisions for generic applications. If a product meets the conditions for a
generic veterinary medicinal product, the applicant is not required to prove
safety and efficacy and the application will rely on the data provided for the
reference product. The proposal contains a definition of generic veterinary
medicinal products.

This part also regulates the ‘protection period’
applying to technical documentation submitted in order to obtain or amend a
marketing authorisation. It addresses the characteristics and specificities of
the veterinary sector. Experience has shown that the needs of the veterinary
sector differ substantially from those of the human sector. Also the drivers for
investment differ for the human and veterinary medicines market, for example in
animal health there is more than one species, creating a fragmented market and
necessitating major investments to add other animal species. Therefore, the
provisions in this proposal to stimulate innovation cannot be considered as a
model for the human medicines market. The protection arrangements prevent applicants
for a generic product from referring to the documentation submitted for the
reference product. Data provided to extend the generic product to another
animal species should also be protected according to the same principle.

Extending the protection periods provided
for in Directive 2001/82/EC should create incentives and stimulate innovation
in the animal health sector. The current ten‑year period would be
maintained for the initial marketing authorisation. In order to encourage
industry to extend already authorised products to other species, a further 1 year
would be added for any extension of the veterinary medicinal products to
another species (up to a maximum of 18 years).

In order to encourage the animal health
industry to develop products for minor species, increased protection will
apply: 14 years for the initial marketing authorisation for a minor species,
and 4 additional years for an extension to a minor species.

So as to secure data protection, any application
for an extension must be submitted at least 3 years before expiry of the data
protection period. This ensures that companies can place a generic product on
the market immediately after expiry of the protection period for the reference
product. Product developments for bee medicines will receive increased data
protection because of the small size of the market for bee medicines and the
lack of effective medicines to treat diseases in bees. The protection applying
to environmental data would be the same as that for safety and efficacy data.

The results of clinical trials comprise much
of the data required to demonstrate the quality, safety and efficacy of a
product. A Union procedure for the authorisation of clinical trials is provided
for (this is currently not harmonised).

It is important to safeguard the
effectiveness of certain antimicrobials that are essential for the treatment of
human infections. Therefore, it is proposed that the Commission be empowered to
establish rules excluding or restricting the use of certain antimicrobials in
the veterinary sector.

Chapter III:   Procedures for granting marketing authorisations

Various marketing authorisation procedures
are provided for:

· 
a centralised procedure, in which the Commission
grants an authorisation;

· 
procedures in which Member States grant the
authorisation:

· 
a national procedure;

· 
a mutual recognition procedure; and

· 
a decentralised procedure.

Regardless of whether the authorisation is
obtained at Union or national level, the requirements for the safety, efficacy
and quality of the product are the same. In all authorisation procedures, a key
part of the assessment of an application is the benefit-risk analysis of a
product.

The centralised procedure is
mandatory for all veterinary medicinal products derived from biotechnology and
optional with any other type of veterinary medicinal product. For products that
are of interest in the majority of the Member States, access to the centralised
procedure can lead to savings for the marketing authorisation holder.

The mutual recognition procedure
applies for veterinary medicinal products already authorised in one Member State for which authorisation is requested in respect of two or more Member States.
This procedure is based on the principle that a product authorised in one Member State should be recognised by another.

The decentralised procedure applies
in cases where a medicine has not received a marketing authorisation in any Member State. It enables applicants to target their product to a limited group of Member
States. After a marketing authorisation has been granted for the group of
Member States in the original application, marketing authorisation holders can
obtain an authorisation for additional Member States without repeated
scientific assessment. This should mean that unnecessary duplication of work by
competent authorities can be avoided, ease the rolling‑out of national
marketing authorisations to other Member States and therefore increase the availability
of veterinary medicinal products in the Union.

For the decentralised and mutual
recognition procedures, an arbitration mechanism applies if a Member State cannot agree with the scientific assessment. If an applicant cannot agree with the
outcome of a Member State’s assessment, it may request re-examination by the
Agency. In such cases, the Agency will deliver a scientific opinion to the coordination
group of Member States, which will act by consensus or by a majority of votes
cast.

Currently, marketing authorisations have to
be renewed every five years. The proposal provides for unlimited validity,
which will reduce the regulatory burden.

Chapter IV:   Post-marketing authorisation measures

This part establishes a single product
database for all authorised veterinary medicinal products in the Union. Competent authorities will be obliged to upload data on national marketing
authorisations. Having a readily accessible, up-to-date database of all
authorised medicines will mean inter alia improved application of the
provisions on the use of veterinary medicinal products outside the terms of the
marketing authorisation, as veterinarians will be able to identify the products
they need from other Member States.

Post-marketing authorisation measures include
amending marketing authorisations and monitoring products after they have been
on the market (pharmacovigilance). The terms of the authorisation may need to
be amended where, for example, a change to the SPC is proposed. The provisions
of Regulation (EC) No 1234/2008 should no longer apply to variations to
veterinary medicinal products. The Regulation lays down a system for varying
the terms of marketing authorisations that takes account of the level of risk
involved. Only changes that substantially affect product safety or efficacy
will still require prior authorisation by the competent authorities or the
Commission before being implemented.

Veterinary medicinal products tend to have
unintended effects when actually brought into use. Pharmacovigilance involves identifying
adverse events and determining what action, if any, is required. The objective
is to ensure the continuous safety of products once they are authorised. This
proposal introduces a risk-based approach to pharmacovigilance whereby certain
requirements that do not contribute effectively to public health, animal health
or environmental protection (e.g. submitting periodic safety update reports)
are relaxed. The Agency will manage a database of adverse events linked to
medicines authorised in the Union. It will work together with competent
authorities to monitor and evaluate collated data on adverse events linked to
similar groups of veterinary medicinal products (signal management process).

Many SPCs of nationally authorised products
may differ in some respects between Member States. As a result, dosage, uses
and warnings may also differ. This lack of harmonisation could result in discrepancies
between the SPCs of the originator and the generic product on the same national
market. This part also seeks to harmonise the SPCs for products on the Union
market that have been authorised at national level by means of a dual procedure:

· 
products considered low-risk will be subject to
an administrative procedure; and

· 
products that are by nature more likely to
present a risk to animal or public health or the environment will be
scientifically re-assessed.

This harmonisation should increase the
availability of products in the Union.

Member States or the Commission can request a re-evaluation of veterinary
medicinal products available on the market on the grounds that they may pose a
risk to animal or public health or the environment. Once this ‘Union referral
procedure’ is triggered, the Agency adopts an opinion on the case and the
Commission adopts a decision that will apply throughout the Union.

In addition, a system will be set up to
record and report the use of antimicrobials. This is one of measures in the
Commission’s AMR action plan.

Chapter V:     Homeopathic veterinary medicinal products

This part lays down requirements and a
simplified registration procedure for homeopathic veterinary medicinal
products.

Chapter VI:   Manufacturing, import and export

This part covers the procedure and
requirements for obtaining an authorisation to manufacture, import or export
veterinary medicinal products. It lays down the obligations of a manufacturing
authorisation holder. These rules will ensure the quality of the medicine
available on the Union market.

Chapter VII:  Supply and use

This part covers the supply and use of
veterinary medicinal products after a marketing authorisation has been granted.
It imposes new restrictions on the supply of antimicrobial veterinary medicinal
products and lays down rules on prescriptions and online sales of veterinary
medicinal products.

In order to improve access to veterinary
medicinal products in the Union, retailers should be allowed to sell products
via the internet if they are authorised to supply them in the Member State in which the buyer is established. Online sales of veterinary medicinal products
throughout the Union must be harmonised and ring-fenced, as falsified or
substandard veterinary medicinal products represent a threat to public and
animal health. Member States may impose conditions, for public health reasons, on
supplying veterinary medicinal products to the public via the internet.

The provisions on the use of veterinary
medicinal products for species or indications outside the terms of the
marketing authorisation are improved as follows:

· 
the ranking system is abolished and more
flexibility introduced, enabling veterinarians to choose the best available
treatment for animals under their care;

· 
withdrawal periods are determined according to a
multiplication factor system which takes account of relevant available
information;

· 
specific provisions are included for the use of
products in an aquatic environment in order to better protect the environment;
and

· 
the Commission is empowered to exclude or
restrict the use of certain antimicrobials.

Chapter VIII:            Controls

Inspections by Member States’ competent
authorities should ensure that the Union rules are complied with and enforced
at national level. The Agency should coordinate the controls of veterinary medicinal
products authorised by the centralised procedure. The key change is that the
Commission will be able to check Member States’ inspection systems to ensure
that the legislation is enforced consistently. This brings the arrangements for
veterinary medicinal products into line with those in the food sector.

Chapter IX:   Restrictions and sanctions

This part deals with Member State and Union-level measures to tackle risks to public or animal health or the environment.
It provides for:

· 
a procedure for temporary safety restrictions;
and

· 
suspending, withdrawing and varying marketing
authorisations; or

· 
prohibiting the supply of veterinary medicinal
products.

Chapter X:     Regulatory network

This part regulates the Union regulatory
network on veterinary medicinal products. Responsibility for veterinary
medicinal products is shared between the Member States and the Commission. The
fully fledged European network between the competent authorities of the Member States, the Agency and the Commission should ensure that:

· 
veterinary medicinal products are available on
the Union market;

· 
they are properly evaluated before being
authorised for use; and

· 
their safety and efficacy is constantly
monitored.

This part of the proposal specifies the
functioning and the tasks of the Agency’s Committee for Medicinal Products for
Veterinary Use (CVMP) and the Coordination Group for Mutual Recognition and
Decentralised Procedures (veterinary) (CMDv). The main changes are to clarify
the remit of the CMDv, which will have more responsibility under the new
arrangements and will take decisions by majority voting. These changes should
improve the functioning of the network. The CVMP’s tasks are amended to reflect
the proposed changes to marketing authorisation procedures and post‑marketing
measures.

Chapter XI:   Final provisions

This proposal repeals and replaces
Directive 2001/82/EC. To give those affected sufficient time to adapt to the
new legislation, the Regulation will apply as from two years after its publication.

Regulation (EC) No 726/2004 must be amended
to take account of the fact that centralised marketing authorisation for
veterinary medicinal products is being decoupled from that for medicines for
humans. The amendments are proposed in a separate act accompanying this
proposal.

4.           BUDGETARY IMPLICATION

It is planned that the costs for the Agency
for implementing and applying the new rules are entirely covered by fees
charged to industry.

Therefore, the proposal is not expected to
have any financial impact on the budget of the EU.

As set out in the legislative financial
statement the additional resource needs for the European Medicines Agency are
approximately 8 staff plus expenditure for meetings, translation, IT, etc.

The level of fees, their structure,
modalities and exceptions will be set at a later stage by the Commission by way
of implementing acts. This holds not only for the fees for new tasks for the Agency
set out in this proposal, but for all fees in general.

5.           OPTIONAL ELEMENTS

2014/0257 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on veterinary medicinal products

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Articles 114 and 168(4)(b)
thereof,

Having regard to the proposal from the
European Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the
European Economic and Social Committee[9],

Having regard to the opinion of the
Committee of the Regions[10],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

(1)       Directive 2001/82/EC of
the European Parliament and of the Council[11]
and Regulation (EC) No 726/2004 of the European Parliament and of the Council[12] constitute the Union
regulatory framework for the placing on the market, manufacture, import,
export, supply, pharmacovigilance, control and the use of veterinary medicinal
products.

(2)       In the light of the
experience acquired and following the assessment by the Commission of the
functioning of the market for veterinary medicinal products, the legal
framework for veterinary medicinal products should be adapted to scientific
progress, the current market conditions and economic reality.

(3)       The legal framework should
take into account the needs of the businesses in the veterinary pharmaceutical
sector and trade in veterinary medicinal products within the Union. It should
also integrate the major policy objectives set out in the Communication from
the Commission of 3 March 2010 "Europe 2020 A Strategy for smart,
sustainable and inclusive growth"[13].

(4)       Experience has shown that
the needs of the veterinary sector differ substantially from those of the human
sector in relation to medicines. In particular, the drivers for investment for
the human and the veterinary medicines markets are different. For example, in
the veterinary sector there are many different animal species, which creates
both a fragmented market and the need for major investments in order to extend
the authorisation of medicines existing for one animal species to another.
Moreover, the price-setting mechanisms in the veterinary sector follow a
completely different logic. Consequently, prices for veterinary medicines are
typically substantially lower than for medicinal products for human use. The
size of the animal pharmaceutical industry is only a small fraction of the size
of the pharmaceutical industry for human medicines.It is therefore appropriate
to develop a regulatory framework addressing the characteristics and
specificities of the veterinary sector, which cannot be considered as a model
for the human medicines market.

(5)       The provisions of this act
aim to reduce administrative burden, enhance the internal market and increase
the availability of veterinary medicinal products, while guaranteeing the
highest level of public and animal health and environmental protection.

(6)       Animals may suffer from a
broad range of diseases which can be prevented or treated. The impact of animal
diseases and the measures necessary to control them can be devastating for
individual animals, animal populations, animal keepers and the economy. Animal
diseases transmissible to humans may also have a significant impact on public
health. Therefore sufficient and effective veterinary medicinal products should
be available in the Union in order to ensure high standards of animal and
public health, and for the development of the agriculture and aquaculture
sectors.

(7)       This Regulation should set
high standards of quality, safety and efficacy for veterinary medicinal
products in order to meet common concerns as regards the protection of public
and animal health. At the same time, this Regulation should harmonise the rules
for the authorisation of veterinary medicinal products and the placing of them on
the Union market.

(8)       With a view to harmonising
the internal market for veterinary medicinal products in the Union and
improving their free movement, rules should be established concerning the
procedures for authorisation of such products that ensure the same conditions
for all applications and a transparent framework for all interested parties.

(9)       The scope of the mandatory
use of a centralised authorisation procedure under which the authorisations are
valid throughout the Union should cover inter alia products containing
new active substances and products which contain or consist of engineered
tissues or cells. At the same time, in order to ensure the widest possible
availability of veterinary medicinal products in the Union, the centralised
authorisation procedure should be extended to allow for applications for
authorisations under that procedure to be submitted for any veterinary
medicinal product, including for generics of nationally authorised veterinary
medicinal products.

(10)     The national procedure for
authorising veterinary medicinal products should be maintained because of
varying needs in different geographical areas of the Union as well as the
business models of small and medium sized enterprises (SMEs).  It should be
ensured that marketing authorisations granted in one Member State are recognised in other Member States.

(11)     In order to help
applicants, and in particular SMEs, to comply with the requirements of this
Regulation, Member States should provide advice to the applicants, for example
by establishing helpdesks. This advice should be provided in addition to the
operational guidance documents and other advice and assistance provided by the
European Medicines Agency.

(12)     In order to avoid
unnecessary administrative and financial burdens for applicants and competent
authorities, a full in-depth assessment of an application for the authorisation
of a veterinary medicinal product should be carried out only once. It is
appropriate therefore to lay down special procedures for the mutual recognition
of national authorisations.

(13)     Moreover, rules should be
established under the mutual recognition procedure to resolve any disagreements
between competent authorities in a coordination group of the Member States
without undue delay.

(14)     Where a Member State or the
Commission considers that there are reasons to believe that a veterinary
medicinal product may present a potential serious risk to human or animal
health or to the environment, a scientific evaluation of the product should be
undertaken at Union level, leading to a single decision on the area of
disagreement, binding on the Member States concerned, being taken on the basis
of an overall benefit-risk assessment.

(15)     No veterinary medicinal
product should be allowed to be placed on the market or used in the Union unless it has been authorised, and its quality, safety and efficacy have been
demonstrated.

(16)     Where a veterinary
medicinal product is intended for food-producing animal species, a marketing
authorisation should only be granted if the pharmacologically active substances
which the product contains are allowed in accordance with Commission Regulation
(EU) No 37/2010[14]
for the species for which the veterinary medicinal product is intended.

(17)     However, there may be situations
where no suitable authorised veterinary medicinal product is available. In
those situations, by way of exception, veterinarians should be allowed to
prescribe other medicinal products to the animals under their responsibility in
conformity with strict rules and in the interest of animal health or animal
welfare only. In case of food-producing animals, veterinarians should ensure
that an appropriate withdrawal period is prescribed, so that harmful residues
of those medicinal products do not enter the food chain.

(18)     Member States should be
able to allow exceptional use of veterinary medicinal products without a
marketing authorisation where it is necessary to respond to Union listed
diseases and where the health situation in a Member State so requires.

(19)     Taking into account the
need for simple rules on changes to the marketing authorisations of veterinary
medicinal products, only changes that may affect animal health, public health
or the environment should require a scientific assessment.

(20)     Directive 2010/63/EU of the
European Parliament and of the Council[15]
lays down provisions on the protection of animals used for scientific purposes
based on the principles of replacement, reduction and refinement. Clinical
trials for veterinary medicinal products are exempted from that Directive. The
design and performance of clinical trials, which provide essential information
on the safety and efficacy of a veterinary medicinal product, should be such as
to provide the most satisfactory results whilst using the minimum number of
animals, the procedures should be the least likely to cause pain, suffering or
distress to animals and should take into account the principles established by
Directive 2010/63/EU.

(21)     The principles of
replacement, reduction and refinement concerning the care and use of live
animals for scientific purposes should therefore be taken into account during
the design and performance of clinical trials.

(22)     It is recognised that
improved access to information contributes to public awareness, gives the
public the opportunity to express its observations and enables authorities to
take due account of those observations. Regulation (EC) No 1049/2001 of the
European Parliament and of the Council[16]
gives the fullest possible effect to the right of public access to documents
and lays down the general principles and limits on such access. The European
Medicines Agency should therefore give the widest possible access to the
documents carefully balancing the right for information with existing data
protection requirements. Certain public and private interests, such as
regarding the protection of personal data, or the protection of commercially
confidential information, should be protected by way of exceptions in
accordance with Regulation (EC) No 1049/2001.

(23)     Companies have less
interest in developing veterinary medicinal products for markets of a limited
size. In order to promote the availability of veterinary medicinal products
within the Union for those markets, in some cases it should be possible to
grant marketing authorisations without a complete application dossier having
been submitted, on the basis of a benefit-risk assessment of the situation and,
where necessary, subject to specific obligations. In particular, this should be
possible in the case of veterinary medicinal products for use in minor species
or for the treatment or prevention of diseases that occur infrequently or in
limited geographical areas.

(24)     Environmental risk
assessments should be mandatory for all new applications for a marketing
authorisation and should consist of two phases. In the first phase the extent
of environmental exposure of the product, its active substances and other constituent
should be estimated, while in the second phase the effects of the active
residue should be assessed.

(25)     Tests, pre-clinical studies
and clinical trials represent a major investment for companies which they need
to make in order to submit the necessary data with the application for a
marketing authorisation or to establish a maximum residue limit for pharmaceutical
active substances in the veterinary medicinal product. That investment should
be protected in order to stimulate research and innovation, so that it is
ensured the necessary veterinary medicinal products are available in the Union. For that reason data submitted to a competent authority or the Agency should be
protected against use by other applicants. That protection should, however, be
limited in time in order to allow competition.

(26)     Certain particulars and
documents that are normally to be submitted with an application for a marketing
authorisation should not be required if a veterinary medicinal product is a
generic medicinal product of a veterinary medicinal product that is authorised
or has been authorised in the Union.

(27)     It is recognised that the
potential effect of a product on the environment may depend on the volume used
and the resulting amount of the pharmaceutical substance that may reach the
environment. Therefore, where there is evidence that a constituent of a
medicinal product for which a generic application for a marketing authorisation
is submitted is a hazard for the environment, it is appropriate to require data
on the potential effect on the environment in order to safeguard the
environment. In such cases applicants should endeavour to join efforts in
generating such data in order to reduce costs and to reduce testing on
vertebrate animals.

(28)     The protection of technical
documentation should be applied to new veterinary medicinal products, as well
as to data developed for supporting innovations of products with or referring
to an existing  marketing authorisation, for example in the case of extending use
of an existing product to an additional animal species. In this case the
variation or marketing authorisation application may refer partly to data
submitted in a former marketing authorisation or variation applications, and
should include new data specifically developed to support the required
innovation of the existing product.

(29)     Differences in the
manufacturing process of biological products or a change in the excipient used
may lead to differences in the generic product characteristics. In an
application for generic biological veterinary medicinal product the
bioequivalence should be demonstrated in order to ensure, based on the existing
knowledge, that quality, safety and efficacy are similar.

(30)     In order to avoid
unnecessary administrative and financial burdens both for the competent
authorities and for the pharmaceutical industry, as a general rule a marketing
authorisation for a veterinary medicinal product should be granted for an
unlimited period of time. Conditions for renewing the approval of a marketing
authorisation should be imposed only exceptionally and should be duly
justified.

(31)     It is recognised that, in
some cases, a scientific risk assessment alone cannot provide all the
information on which a risk management decision should be based, and other relevant
factors should be taken into account including societal, economical, ethical,
environmental and welfare factors and the feasibility of controls.

(32)     In certain circumstances
where a significant animal or public health concern exists but scientific uncertainty
persists, appropriate measures can be adopted taking into account Article 5(7)
of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures
which has been interpreted for the Union in the Communication from the
Commission on the precautionary principle[17]. 
In such circumstances, Member States or the Commission should seek to obtain
additional information necessary for a more objective assessment of the
particular concern and should review the measure accordingly within a reasonable
period of time.

(33)     Antimicrobial resistance to
human and veterinary medicinal products is a growing health problem in the Union and worldwide. Many of the antimicrobials used in animals are also used in humans.
Some of those antimicrobials are critical for preventing or treating
life-threatening infections in humans.  In order to fight antimicrobial
resistance a number of measures should be taken. It needs to be ensured that
appropriate warnings and guidance are included on the labels of veterinary antimicrobials.
Use not covered by the terms of the marketing authorisation of certain new or
critically important antimicrobials for humans should be restricted in the
veterinary sector. The rules for advertising veterinary antimicrobials should
be tightened, and the authorisation requirements should sufficiently address
the risks and benefits of antimicrobial veterinary medicinal products.

(34)     It is necessary to mitigate
the risk of development of antimicrobial resistance to human and veterinary
medicinal products. Therefore, an application for an antimicrobial veterinary
medicinal product should contain information about the potential risks that use
of the product may lead to the development of antimicrobial resistance in
humans or animals or in organisms associated with them. In order to ensure a
high level of public and animal health, veterinary antimicrobials should only
be authorised following a careful scientific benefit-risk assessment.  If
necessary, conditions should be laid down in the marketing authorisation in
order to restrict the use of the product. This should include restrictions on
the use of the veterinary medicinal product not in accordance with the terms of
the marketing authorisation, in particular the summary of product
characteristics of the veterinary medicinal product.

(35)     The combined use of several
antimicrobial active substances may represent a particular risk with respect to
the development of antimicrobial resistance. Combinations of antimicrobial
substances should therefore only be authorised where evidence is provided that
the benefit-risk balance of the combination is favourable.

(36)     The development of new
antimicrobials has not kept pace with the increase of resistance to existing
antimicrobials. Given the limited innovation in developing new antimicrobials
it is essential that the efficacy of existing antimicrobials is maintained for
as long as possible. The use of antimicrobials in veterinary medicinal products
may accelerate the emergence and spread of resistant micro-organisms and may
compromise the effective use of the already limited number of existing
antimicrobials to treat human infections. Therefore the misuse of
antimicrobials should not be allowed.

(37)     In order to preserve as
long as possible the efficacy of certain antimicrobials in the treatment of
infections in humans, it may be necessary to reserve those antimicrobials for
humans only. Therefore it should be possible to decide that certain
antimicrobials, following the scientific recommendations of the Agency, should
not be available on the market in the veterinary sector.

(38)     If an antimicrobial is
administered and used incorrectly, this presents a risk to public or animal
health. Therefore antimicrobial veterinary medicinal products should only be
available on veterinary prescription. Persons having the right to prescribe
have a key role in ensuring prudent use of antimicrobials and consequently they
should not be influenced, directly or indirectly, by economic incentives when
prescribing those products. Therefore the supply of veterinary antimicrobials
by those health professionals should be restricted to the amount required for
treatment of the animals under their care.

(39)     It is important to consider
the international dimension of the development of antimicrobial resistance when
assessing the benefit-risk balance of certain veterinary antimicrobials in the Union. Any measure restricting the use of those products may affect the trade of products
of animal origin or the competitiveness of certain animal production sectors in
the Union. Moreover, antimicrobial resistant organisms can spread to humans and
animals in the Union through consumption of products of animal origin imported
from third countries, from direct contact with animals or humans in third countries
or by other means. Therefore, measures restricting the use of veterinary
antimicrobials in the Union should be based on scientific advice and should be
considered in the context of cooperation with third countries and international
organisations addressing antimicrobial resistance in order the ensure
consistency with their activities and policies.

(40)     There is still a lack of
sufficiently detailed and comparable data at Union level to determine the
trends and identify possible risk factors that could lead to the development of
measures to limit the risk from antimicrobial resistance and to monitor the
effect of measures already introduced. Therefore it is important to
collect data on the sales and use of antimicrobials in animals, data on the use
of antimicrobials in humans and data on antimicrobial resistant organisms found
in animals, humans and food. To ensure that the information collected can be
used effectively, appropriate rules should be laid down concerning the
collection and the exchange of data. The Member States should be responsible
for collecting data on the use of antimicrobials under the coordination of the
Agency.

(41)     The majority of the
veterinary medicinal products on the market have been authorised under national
procedures. The lack of harmonisation of summary of product characteristics for
veterinary medicinal products authorised nationally in more than one Member State creates additional and unnecessary barriers for the circulation of veterinary
medicinal products within the Union. It is necessary to harmonise those
summaries of product characteristics. In order to avoid unnecessary costs and
burdens for the Member States, the Commission and the pharmaceutical industry,
and in order to increase the availability of veterinary medicinal products as
fast as possible, it should be possible to harmonise summaries of the products
characteristics for certain veterinary medicinal products in accordance with an
administrative procedure, while taking on board the risk to public and animal
health and to the environment. This harmonisation exercise should cover
veterinary medicinal products authorised before 2004.[18].

(42)     In order to reduce
administrative burden and maximise the availability of veterinary medicinal
products in the Member States, simplified rules should be laid down as to how
their packaging and labelling are to be presented. The textual information
provided should be reduced and, if possible, replaced by pictograms and
abbreviations. Pictograms and abbreviations should be standardised across the Union. Care should be taken so that those rules do not jeopardise public and animal health
and environmental safety.

(43)     In addition, Member States
should be empowered to choose the language of the text used in the packaging
and labelling of veterinary medicinal products authorised in their territory.
The package leaflet, however, should be provided in the official language or
languages of the Member State.

(44)     With a view to increasing
availability of veterinary medicinal products in the Union it should be
possible to grant more than one marketing authorisation for a specific
veterinary medicinal product to the same marketing authorisation holder in the
same Member State. In that case all product-related characteristics of the
product and data in support of the applications for the product should be
identical. However, multiple applications for a specific product should not be
used to circumvent the principles of mutual recognition, and therefore this
type of applications in different Member States should take place inside the
procedural framework for mutual recognition.

(45)     Pharmacovigilance rules are necessary for the protection of
public and animal health and the
environment. Collection of information on adverse
events should contribute to the good usage of veterinary medicinal products.

(46)     In the light of the
experience acquired it has become clear that it is necessary to take measures
to improve the operation of the pharmacovigilance system. It should integrate
and monitor data at Union level. It is the interest of the Union to ensure that
the veterinary pharmacovigilance systems for all authorised veterinary
medicinal products are consistent. At the same time, it is necessary to take
account of changes arising as a result of international harmonisation of
definitions, terminology and technological developments in the field of
pharmacovigilance.

(47)     Holders of marketing
authorisations should be responsible for continuously carrying out pharmacovigilance
of the veterinary medicinal products they place on the market. They should
collect reports on adverse events relating to their products, including those
concerning use outside the terms of the granted marketing authorisation.

(48)     It is necessary to increase
the shared use of resources between authorities, and to enhance efficiency of
the pharmacovigilance system. Data collected should be uploaded to a single
reporting point to ensure that the information is shared. The competent
authorities should use those data to ensure the continuous safety and efficacy
of the veterinary medicinal products that are on the market.

(49)     It is necessary, in
specific cases, or from a public health and animal health perspective, to
complement the safety and efficacy data available at the time of authorisation
with additional information following the placing of the product on the market.
Therefore the obligation to conduct post-authorisation studies should be
imposed on the marketing authorisation holder.

(50)     A pharmacovigilance
database at Union level should be established to record and integrate
information of adverse events for all veterinary medicinal products authorised
in the Union. That database should improve detection of adverse events and should
allow and facilitate the pharmacovigilance surveillance and work-sharing
between the competent authorities.

(51)     It is necessary to exercise
control over the entire chain of distribution of veterinary medicinal products,
from manufacture or import into the Union through supply to the end-user.
Veterinary medicinal products from third countries should comply with the same
requirements which apply to products manufactured in the Union, or with
requirements which are recognised to be at least equivalent thereto.

(52)     In order to facilitate the
movement of veterinary medicinal products and to prevent checks carried out in
one Member State being repeated in others, minimum requirements should be
applied to veterinary medicinal products manufactured in or imported from third
countries.

(53)     The quality of veterinary
medicinal products manufactured within the Union should be guaranteed by
requiring compliance with the principles of good manufacturing practice for
medicinal products irrespective of the final destination of the medicinal
products.

(54)     Companies should be in
possession of an authorisation to be able to wholesale or retail veterinary
medicinal products, so as to guarantee that such medicines are appropriately
stored, transported and handled. It should be the responsibility of the Member
States to ensure that those conditions are met. Those authorisations should be
valid throughout the Union.

(55)     In order to ensure
transparency, a database should be established at Union level for the purposes
of publishing a list of wholesale distributors who have been found to comply
with applicable Union legislation following an inspection by the competent
authorities of a Member State.

(56)     The conditions governing
the supply of veterinary medicinal products to the public should be harmonised
in the Union. Veterinary medicinal products should only be supplied by persons
authorised to do so by the Member State where they are established. At the same
time, in order to improve access to veterinary medicinal products in the Union,
retailers that are authorised to supply veterinary medicinal products by the competent
authority in the Member State where they are established should be allowed to
sell prescription and non-prescription veterinary medicinal products via the
Internet to buyers in other Member States.

(57)     The illegal sale of
veterinary medicinal products to the public via the Internet may represent a
threat to public and animal health, as falsified or substandard medicines may
reach the public in this way. It is necessary to address this threat. Account
should be taken of the fact that specific conditions for supply of medicinal
products to the public have not been harmonised at Union level and, therefore,
Member States may impose conditions for supplying medicinal products to the
public within the limits of the Treaty.

(58)     When examining the
compatibility with Union law of the conditions for the supply of medicinal
products, the Court of Justice of the European Union has recognised, in the
context on medicinal products for human use, the very particular nature of
medicinal products whose therapeutic effects distinguish them substantially
from other goods. The Court of Justice has also held that health and life of
humans rank foremost among the assets and interests protected by the Treaty and
that it is for Member States to determine the level of protection which they
wish to afford to public health and the way in which that level has to be
achieved. Since that level may vary from one Member State to another, Member
States must be allowed some discretion as regards the conditions for the supply
on their territory of medicinal products to the public. Therefore Member States
should be able to subject the supply of medicinal products offered for sale at
a distance by means of information society services to conditions justified by
the protection of public health. Such conditions should not unduly restrict the
functioning of the internal market.

(59)     In order to ensure high
standards and safety of the veterinary medicinal products offered for sale at a
distance, the public should be assisted in identifying websites which are
legally offering such medicinal products. A common logo should be established,
which is recognisable throughout the Union, while allowing for the
identification of the Member State where the person offering veterinary
medicinal products for sale at a distance is established. The Commission should
develop the design for such a logo. Websites offering veterinary medicinal
products for sale at a distance to the public should be linked to the website of
the competent authority concerned. The websites of the competent authorities of
Member States, as well as that of the European Medicines Agency, should give an
explanation of the use of the logo. All those websites should be linked in
order to provide comprehensive information to the public.

(60)     Collection systems for the
take-back of unused or expired veterinary medicinal products should continue to
be in place in the Member States in order to control any risk that such
products might raise with regard to the protection of animal, human health or
the environment.

(61)     Advertising, even on
non-prescription medicinal products, could affect public and animal health and
distort competition. Therefore, advertising of veterinary medicinal products
should satisfy certain criteria. Persons qualified to prescribe or supply can properly
evaluate the information available in advertising because of their knowledge,
training and experience in animal health. The advertising of veterinary
medicinal products to persons who cannot properly appreciate the risk
associated with their use may lead to medicine misuse or overconsumption which
is liable to harm public or animal health, or the environment.

(62)     Where medicinal products
are authorised within a Member State and have been prescribed in that Member State by a member of a regulated animal health profession for an individual animal or
group of animals, it should in principle be possible for that veterinary
prescription to be recognised and for the medicinal product to be dispensed in
another Member State. The removal of regulatory and administrative barriers to
such recognition should not affect any professional or ethical duty for
dispensing professionals to refuse to dispense the medicine stated in the
prescription.

(63)     The implementation of the
principle of recognition of prescriptions should be facilitated by the adoption
of a standard prescription, listing the essential information necessary to
ensure the safe and efficacious use of the product. Nothing should prevent
Member States from having further elements in their prescriptions, as long as
this does not prevent prescriptions from other Member States from being
recognised.

(64)     Information on veterinary
medicinal products is essential in order to enable health professionals,
authorities and undertakings to make informed decisions. A key aspect is the
creation of a European database that should collate information on marketing
authorisations granted in the Union. The database should enhance overall
transparency, streamline and facilitate the flow of information between
authorities and prevent multiple reporting requirements.

(65)     The verification of
compliance with the legal requirements through controls is of fundamental
importance to ensure that the objectives of the Regulation are effectively
achieved across the Union. Therefore the competent authorities of the Member
States should have the power to perform inspections at all stages of
production, distribution and use of veterinary medicinal products. In order to
preserve the effectiveness of the inspections, authorities should have the
possibility to perform unannounced inspections.

(66)     The frequency of controls
should be established by the competent authorities having regard to the risk
and to the level of compliance expected in the different situations. This
approach should allow authorities to allocate resources where the risk is the
highest. In some cases, however, controls should be performed irrespective of
the level of risk or expected non-compliance, for example prior to granting
manufacturing authorisations.

(67)     In certain cases failures
in Member States’ control system can substantially hinder the achievement of
the objectives of this Regulation and may lead to the emergence of risks to
public and animal health and the environment. To ensure a harmonised approach
to inspections throughout the Union, the Commission should be able to carry out
audits in the Member States to verify the functioning of national control
systems.

(68)     In order to ensure transparency,
impartiality and consistency in the level of enforcement activities by Member
States, it is necessary for Member States to set up an appropriate framework
for penalties with a view to imposing effective, proportionate and dissuasive
penalties for non-compliance, as non-compliance can result in damage to animal
and public health and the environment.

(69)     At the same time, the power
to adopt acts in accordance with Article 290 of the Treaty should be delegated
to the Commission in respect of laying down the
procedure for investigating the infringements and the imposition of fines to
the holders of marketing authorisations granted under this Regulation, the
maximum amounts of these penalties as well as the conditions and methods for
their collection.

(70)     Companies and authorities
are frequently confronted with the need to distinguish between veterinary
medicinal products, feed additives, biocidal products and other products. In
order to avoid inconsistencies in the treatment of such products, to increase
legal certainty, and to facilitate the decision process by Member States, a
coordination group of Member States should be established, and among other
tasks it should provide on a case-by-case basis a recommendation whether a
product falls within the definition of a veterinary medicinal product. In order
to ensure legal certainty the Commission may decide whether a specific product
is a veterinary medicinal product.

(71)     Having regard to the
special characteristics of homeopathic veterinary medicinal products,
especially the constituents of these products, it is desirable to establish a
special, simplified registration procedure and to provide specific provisions
for labelling for certain homeopathic veterinary medicinal products which are
placed on the market without therapeutic indications. Immunological homeopathic
products cannot follow the simplified registration procedure as immunologicals
may initiate a response at a high dilution rate. The quality aspect of a
homeopathic medicinal product is independent of its use so no specific
provisions should apply with regard to the necessary quality requirements and
rules.

(72)     In order to follow the
scientific developments of the sector, the power to adopt acts in accordance
with Article 290 of the Treaty should be delegated to the Commission in respect
of amending the rules on designation of homeopathic veterinary medicinal
products for which registration procedure should be allowed.

(73)     In order to protect public
health, animal health and the environment, the activities and tasks attributed
to the Agency in this Regulation should be adequately funded. Those activities,
services and tasks should be funded through fees charged to enterprises. Those
fees, however, should not affect the right of Member States to charge fees for
activities and tasks at national level.

(74)     In order to ensure that
annexes to this Regulation are adapted to the technical and scientific
developments, the power to adopt acts in accordance with Article 290 of the
Treaty should be delegated to the Commission.

(75)     In order to adapt this
Regulation to the scientific developments of the sector, the power to adopt
acts in accordance with Article 290 of the Treaty should be delegated to the
Commission in respect of the use of a product outside the terms of the granted
marketing authorisation, in particular regarding establishing a list of
antimicrobial veterinary medicinal products for which such use should be
prohibited.

(76)     In order to adapt this
Regulation to the scientific developments of the sector, the power to adopt
acts in accordance with Article 290 of the Treaty should be delegated to the
Commission in respect of amending the list of groups of veterinary medicinal
products for which the centralised authorisation procedure shall be compulsory.

(77)     In order to adapt this
Regulation to the scientific developments of the sector, the power to adopt
acts in accordance with Article 290 of the Treaty should be delegated to the
Commission in respect of establishing detailed rules on the principles for the
refusal or restriction of marketing authorisations of antimicrobial veterinary
medicinal products, in particular with a view to preserving the efficacy of
certain active substances in treating infections in humans.

(78)     In order to exercise its
supervisory powers effectively, the power to adopt acts in accordance with
Article 290 of the Treaty should be delegated to the Commission in respect of laying down the procedure for investigating the infringements and
the imposition of fines or periodic penalty payments to the holders of
marketing authorisations granted under this Regulation, the maximum amounts of
these penalties as well as the conditions and methods for their collection.

(79)     In order to introduce
harmonised standards within the Union for the methods of gathering data on the
use of antimicrobials and the methods of transferring of these data to the
Commission, the power to adopt acts in accordance with Article 290 of the
Treaty should be delegated to the Commission in respect of establishing rules
on these methods.

(80)     In order to ensure uniform
conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exercised in
accordance with Regulation (EU) No 182/2011 of the European Parliament and of
the Council[19].

(81)     Taking into account the
main changes that should be made to the existing rules, and aiming to improve
the functioning of the internal market, a regulation is the appropriate legal
instrument to replace Directive 2001/82/EC in order to lay down clear, detailed
and directly applicable rules. Moreover, a regulation ensures that legal
requirements are implemented at the same time and in a harmonised manner
throughout the Union.

(82)     Since the objectives of
this Regulation, namely to establish rules on veterinary medicinal products
ensuring the protection of human and animal health and the environment as well
as the functioning of the internal market, cannot be sufficiently achieved by
the Member States, but can rather, by reason of its effects, be better achieved
at Union level, the Union may adopt measures, in accordance with the principle
of subsidiarity as set out in Article 5 of the Treaty on European Union. In
accordance with the principle of proportionality, as set out in that Article,
this Regulation does not go beyond what is necessary in order to achieve those
objectives,

HAVE ADOPTED THIS REGULATION:

Chapter I 
Subject matter, scope and definitions

Article 1
Subject matter

This Regulation lays down rules for the placing
on the market, manufacture, import, export, supply, pharmacovigilance, control
and use of veterinary medicinal products.

Article 2
Scope

1.           This Regulation shall
apply to veterinary medicinal products prepared industrially or by a method involving
an industrial process and intended to be placed on the market.

2.           In addition to the
products referred to in paragraph 1, Chapter VI shall also apply to active
substances, intermediate products and excipients used as starting materials in
veterinary medicinal products.

3.           In addition to the
products referred to in paragraph 1, Chapter VII shall also apply to:

(a) 
substances that have anabolic, anti-infectious,
anti-parasitic, anti-inflammatory, hormonal or psychotropic properties and that
may be used in animals;

(b) 
veterinary medicinal products prepared in a
pharmacy in accordance with a veterinary prescription for an individual animal
or a small group of animals (‘magistral formula’);

(c) 
veterinary medicinal products prepared in a
pharmacy in accordance with the directions of a pharmacopoeia and intended to
be supplied directly to the end-user (‘officinal formula’).

4.           This Regulation shall not
apply to:

(a) 
inactivated immunological veterinary medicinal
products which are manufactured from pathogens and antigens obtained from an
animal or animals from a holding and used for the treatment of that animal or
those animals in the same locality;

(b) 
veterinary medicinal products containing
autologous or allogeneic cells or tissues that have not been subjected to an industrial
process;

(c) 
veterinary medicinal products based on
radio-active isotopes;

(d) 
feed additives as defined in  Regulation (EC) No
1831/2003 of the European Parliament and of the Council[20];

(e) 
veterinary medicinal products intended for
research and development.

Article 3
Conflict of laws

1.           Where a veterinary
medicinal product referred to in Article 2(1) also falls within the scope of
Regulation (EU) No 528/2012 of the European Parliament and of the Council[21] or Regulation (EC) No
1831/2003 of the European Parliament and of the Council, and there is a
conflict between the provisions of this Regulation and the provisions of
Regulation (EU) No 528/2012 or Regulation (EC) No 1831/2003, the provisions of
this Regulation shall prevail.

2.           The Commission may, by
means of implementing acts, adopt decisions on whether a specific product or
group of products is to be considered as a veterinary medicinal product. Those
implementing acts shall be adopted in accordance with the examination procedure
referred to in Article 145(2).

Article 4
Definitions

For the purposes of this Regulation, the
following definitions shall apply:

(1) 
‘veterinary medicinal product’ means any
substance or combination of substances which fulfils at least one of the
following conditions:

(a) 
it is presented as having properties for
treating or preventing disease in animals;

(b) 
its purpose is to be used in or administered to
animals with a view to restoring, correcting or modifying physiological
functions by exerting a pharmacological, immunological or metabolic action, or
to making a medical diagnosis;

(c) 
its purpose is to be used for euthanasia of
animals;

(2) 
‘substance’ means any matter of the following
origin:

(a) 
human,

(b) 
animal,

(c) 
vegetable,

(d) 
chemical;

(3) 
‘immunological veterinary medicinal product’
means a veterinary medicinal product consisting of vaccines, toxins, sera or
allergen products and intended to be administered to an animal in order to
produce active or passive immunity or to diagnose its state of immunity;

(4) 
‘biological veterinary medicinal product’ means
a veterinary medicinal product an active substance of which is a biological
substance;

(5) 
‘biological substance’ means a substance that is
produced by or extracted from a biological source and that needs for its
characterisation and the determination of its quality a combination of
physico-chemical-biological testing, together with knowledge of the production
process and its control;

(6) 
‘generic veterinary medicinal product’ means a
veterinary medicinal product which has the same qualitative and quantitative
composition of active substances and the same pharmaceutical form as the
reference medicinal product, and with regard to which appropriate
bioavailability studies have demonstrated a bioequivalence with the reference
veterinary medicinal product;

(7) 
‘homeopathic veterinary medicinal product’ means
a veterinary medicinal product prepared from homeopathic stocks in accordance
with a homeopathic manufacturing procedure described by the European
Pharmacopoeia or, in the absence thereof, by the pharmacopoeias used officially
in Member States;

(8) 
‘antimicrobial resistance’ means the ability of
microorganisms to survive or to grow in the presence of a concentration of an
antimicrobial agent which is usually sufficient to inhibit or kill
microorganisms of the same species;

(9) 
‘clinical trial’ means a study which aims to examine
under field conditions the safety or efficacy of a veterinary medicinal product
or both under normal conditions of animal husbandry or as part of normal
veterinary practice for the purpose of obtaining a marketing authorisation or a
change thereof;

(10) 
‘pre-clinical study’ means a study not covered
by the definition of clinical trial which aims to investigate the safety or
efficacy of a veterinary medicinal product for the purpose of obtaining a
marketing authorisation or a change thereof;

(11) 
‘benefit-risk balance’ means an evaluation of
the positive effects of the veterinary medicinal product in relation to the
following risks relating to the use of that product:

(a) 
any risk relating to the quality, safety and
efficacy of the veterinary medicinal products as regards animal or human
health;

(b) 
any risk of undesirable effects on the
environment;

(c) 
any risk relating to the development of
antimicrobial resistance;

(12) 
‘common name’ means  the international
non-proprietary name recommended by the World Health Organisation for a
veterinary medicinal product, or, if one does not exist, the name generally
used;

(13) 
‘strength’ means  the content of active
substances in a veterinary medicinal product, expressed quantitatively per
dosage unit, per unit of volume or per unit of weight according to the
pharmaceutical form;

(14) 
‘competent authority’ means an authority
designated by a Member State in accordance with Article 136;

(15) 
‘labelling’ means  information on the immediate
packaging or the outer packaging;

(16) 
‘outer packaging’ means packaging in which is
placed the immediate packaging;

(17) 
‘immediate packaging’ means the container or any
other form of packaging that is in direct contact with the veterinary medicinal
product;

(18) 
‘package leaflet’ means a documentation leaflet
on a veterinary medicinal product which contains information to ensure its safe
and efficacious use;

(19) 
‘letter of access’ means an original document,
signed by the data owner or its representative, which states that the data may
be used for the benefit of a third party by the competent authorities, the
Agency or the Commission for the purposes of this Regulation;

(20) 
‘limited market’ means a market for one of the
following product types:

(a) 
veterinary medicinal products for the treatment
or prevention of diseases that occur infrequently or in limited geographical
areas;

(b) 
veterinary medicinal products for animal species
other than cattle, sheep, pigs, chickens, dogs and cats;

(21) 
‘pharmacovigilance’ means the process of
monitoring and investigating adverse events;

(22) 
‘pharmacovigilance system master file’ means a
detailed description of the pharmacovigilance system used by the marketing
authorisation holder with respect to one or more authorised veterinary
medicinal products;

(23) 
‘control’ means any task performed by a
competent authority, including inspections, for the verification of compliance
with this Regulation;

(24) 
‘veterinary prescription‘ means  any
prescription for a veterinary medicinal product issued by a professional person
qualified to do so in accordance with applicable national law;

(25) 
‘withdrawal period’ means the minimum period
between the last administration of a veterinary medicinal product to an animal
and the production of foodstuffs from that animal which under normal conditions
of use is necessary to ensure that such foodstuffs do not contain residues in
quantities harmful to public health;

(26) 
‘making available on the market’ means any
supply of a veterinary medicinal product for distribution, consumption or use
on the Union market in the course of a commercial activity, whether in return
for payment or free of charge;

(27) 
‘placing on the market’ means the first making
available of a veterinary medicinal product on the Union market.

Chapter II 
Marketing authorisations – general provisions and rules on applications

Section 1 
General provisions

Article 5
Marketing authorisations

1.           A veterinary medicinal
product shall be placed on the market only when a marketing authorisation has
been granted in respect of the product by a competent authority in accordance with
Articles 44, 46 or 48 or by the Commission in accordance with Article 40.

2.           A marketing authorisation
for a veterinary medicinal product shall be valid for an unlimited period of
time.

3.           Decisions to grant,
refuse, suspend, withdraw or vary a marketing authorisation shall be made
public.

4.           Applicants for marketing
authorisations and marketing authorisation holders shall be established in the Union.

Article 6
Submission of applications for marketing authorisations

1.           Applications shall be
submitted to the competent authority where they concern  the granting of
marketing authorisations in accordance with any of the following procedures:

(a) 
the national procedure laid down in Articles 42,
43 and 44;

(b) 
the decentralised procedure laid down in
Articles 45 and 46;

(c) 
the mutual recognition procedure laid down in
Articles 47 and 48.

2.           Applications for the
granting of marketing authorisations in accordance with the centralised
marketing authorisation procedure laid down in Articles 38 to 41 shall be
submitted to the European Medicines Agency (‘the Agency’) established by
Regulation (EC) No 726/2004.

3.           Applications shall be
submitted electronically. For applications submitted in accordance with the
centralised marketing authorisation procedure, the formats made available by
the Agency shall be used.

4.           The applicant shall be
responsible for the accuracy of the documents and data submitted.

5.           Within 15 days of receipt
of the application, the competent authority or the Agency shall notify the
applicant of whether all data required in accordance with Article 7 have been
presented.

6.           Where the competent
authority or the Agency considers that the application is incomplete, it shall
inform the applicant accordingly and shall set a time limit for submitting the
missing information.

Section 2 
Dossier requirements

Article 7
Data to be submitted with the application

1.           An application for a
marketing authorisation shall contain the following information:

(a) 
the administrative information set out in Annex
I;

(b) 
technical documentation satisfying the
requirements set out in Annex II;

(c) 
the information to be provided in the immediate
packaging, outer packaging and the package leaflet in accordance with Articles
9 to 14.

2.           Where the application
concerns an antimicrobial veterinary medicinal product, the following shall be
submitted in addition to the information listed in paragraph 1:

(a) 
documentation on the direct or indirect risks to
public or animal health of use of the antimicrobial veterinary medicinal
product in animals,

(b) 
information about risk mitigation measures to
limit antimicrobial resistance development related to the use of veterinary
medicinal product.

3.           Where the application
concerns a veterinary medicinal product intended for food-producing target
species and containing pharmacologically active substances that are not listed
in Table 1 of the Annex to Regulation (EU) No 37/2010 for the animal species in
question, a document certifying that a valid application for the establishment
of maximum residue limits has been submitted to the Agency in accordance with
Regulation (EC) No 470/2009 of the European Parliament and of the Council[22] shall be submitted in
addition to the information listed in paragraph 1.

4.           Paragraph 3 shall not
apply to veterinary medicinal products intended for animals of the equidae
family that have been declared as not being intended for slaughter for human
consumption in accordance with Commission Regulation (EC) 504/2008[23] and the active
substances contained in those veterinary medicinal products are not listed in
Table 2 of the Annex to Regulation (EU) No 37/2010.

5.           Where the application
concerns a veterinary medicinal product containing or consisting of genetically
modified organisms within the meaning of Article 2 of Directive 2001/18/EC of
the European Parliament and of the Council[24]
the application shall in addition to the documents listed in paragraph 1 be
accompanied by:

(a) 
a copy of the written consent of the competent
authorities to the deliberate release into the environment of the genetically
modified organisms for research and development purposes, as provided for in
Part B of Directive 2001/18/EC;

(b) 
the complete technical file supplying the
information required under Annexes III and IV to Directive 2001/18/EC;

(c) 
the environmental risk assessment in accordance
with the principles set out in Annex II to Directive 2001/18/EC; and

(d) 
the results of any investigations performed for
the purposes of research or development.

6.           Where the application is
submitted in accordance with the national procedure laid down in Articles 42, 43
and 44, the applicant shall, in addition to the information listed in paragraph
1, submit a declaration stating that he has not submitted an application for a
marketing authorisation for the veterinary medicinal product in another Member State.

7.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 146 in order to
amend Annexes I and II to adapt the information and documentation requirements
to technical and scientific progress.

Section 3 
Clinical trials

Article 8
Approval of clinical trials

1.           An application for the
approval of a clinical trial shall be submitted to a competent authority of the
  Member State in which the clinical trial is to take place.

2.           Approvals of clinical
trials shall be granted on condition that food-producing animals used in the
clinical trials or their produce do not enter the human food chain unless:

(a) 
the tested product is a veterinary medicinal
product authorised for the food-producing species used in the clinical trial,
and the withdrawal period set out in the summary of the product characteristics
is respected, or

(b) 
the tested product is an authorised veterinary
medicinal product for target species other than the food-producing species used
in the clinical trial and the withdrawal period set out in accordance with
Article 117 is respected.

3.           The competent authority
shall issue a decision on the approval of a clinical trial within 60 days after
the receipt of an application. Where the competent authority has not notified
the applicant of its decision within that time limit, the clinical trial shall
be considered to have been approved.

4.           The clinical trials
referred to in paragraph 1 shall be carried out taking due account of the
standards set by the international guidelines on good clinical practice of the
International Cooperation on Harmonisation of Technical Requirements for
Registration of Veterinary Medicinal Products.

5.           Results of clinical trials
shall be submitted with the application for a marketing authorisation for the
purposes of providing the documentation referred to in Article 7(1)(b).

6.           Data stemming from
clinical trials conducted outside the Union may be taken into consideration for
the assessment of an application for a marketing authorisation only if those trials
were designed, implemented and reported in accordance with the standards set by
the international guidelines on good clinical practice of the International
Cooperation on Harmonisation of Technical Requirements for Registration of
Veterinary Medicinal Products.

Section 4 
Labelling and package leaflet

Article 9
Labelling of the immediate packaging of veterinary medicinal products

1.           The immediate packaging of
a veterinary medicinal product shall contain only the following information:

(a) 
the name of the veterinary medicinal product,
followed by its strength and pharmaceutical form;

(b) 
a statement of the active substances expressed
qualitatively and quantitatively per unit or according to the form of
administration for a particular volume or weight, using their common names;

(c) 
the batch number, preceded by the word "Lot";

(d) 
the name or corporate name or logo name of the
marketing authorisation holder;

(e) 
the target species;

(f) 
the expiry date, in the format:
"mm/yyyy", preceded by the abbreviation "Exp.";

(g) 
special storage precautions, if any.

2.           The information listed in
paragraph 1 shall appear in easily legible and clearly comprehensible
characters, or, where appropriate, abbreviations or pictograms common
throughout the Union.

Article 10
Labelling of the outer packaging of veterinary medicinal products

1.           The outer packaging of a
veterinary medicinal product shall contain only the following information:

(a) 
the information listed in Article 9(1);

(b) 
the contents by weight, volume or number of
immediate packaging units of the veterinary medicinal product;

(c) 
warning that the veterinary medicinal product
must be kept out of the sight and reach of children;

(d) 
warning that the veterinary medicinal product is
for animal treatment only;

(e) 
recommendation to read the package leaflet;

(f) 
requirement to use take-back schemes for
veterinary medicinal products for the  disposal of unused veterinary medicinal
products or waste materials derived from the use of such products and, if
appropriate, additional precautions as regarding hazardous waste disposal of
unused veterinary medicinal products or waste materials derived from the use of
such products;

(g) 
in case of homeopathic veterinary medicinal
products, the statement "homeopathic veterinary medicinal product".

2.           The information listed in
paragraph 1 shall appear in easily legible and clearly comprehensible
characters, or, where appropriate, abbreviations or pictograms common
throughout the Union.

3.           Where there is no outer
packaging, all the particulars listed in paragraph 1 shall appear on the immediate
packaging.

Article 11
Labelling of small immediate packaging units of veterinary medicinal products

By way of derogation from Article 9, small
immediate packaging units shall contain only the following information:

(a) 
the name of veterinary medicinal product;

(b) 
the quantitative particulars of the active
substances;

(c) 
the batch number, preceded by the word "Lot";

(d) 
the expiry date, in the format:
"mm/yyyy", preceded by the abbreviation "Exp.".

Article 12
Package leaflet of veterinary medicinal products

1.           The package leaflet shall
be available for each veterinary medicinal product and shall contain at least
the following information:

(a) 
the name or corporate name and permanent address
or registered place of business of the marketing authorisation holder and of the
manufacturer and, where applicable, of the representative of the marketing
authorisation holder;

(b) 
the name of the veterinary medicinal product 
or, where applicable, a list of the names of the veterinary medicinal product,
as authorised in different Member States;

(c) 
the strength and pharmaceutical form of the
veterinary medicinal product;

(d) 
the target species, the dosage for each species,
the method and route of administration and advice on correct administration, if
necessary;

(e) 
the therapeutic indications;

(f) 
the contra-indications and adverse events in so
far as this information is necessary for the use of the veterinary medicinal
product;

(g) 
the withdrawal period, even if this is nil, in
the event that the target species are food-producing animals;

(h) 
special storage precautions, if any;

(i) 
information essential for safety or health
protection, including any special precautions relating to use and any other
warnings;

(j) 
requirement to use take-back schemes for
veterinary medicinal products for the  disposal of unused veterinary medicinal
products or waste materials derived from the use of such products and, if
appropriate, additional precautions regarding hazardous waste disposal of
unused veterinary medicinal products or waste materials derived from the use of
such products;

(k) 
the marketing authorisation number;

(l) 
in case of generic veterinary medicinal
products, the statement ‘generic veterinary medicinal product’;

(m) 
in case of homeopathic veterinary medicinal
products, the statement "homeopathic veterinary medicinal product".

2.           The package leaflet may
bear additional information concerning distribution, possession or any
necessary precaution in conformity with the marketing authorisation, provided
that the information is not promotional. This additional information shall
appear in the package leaflet clearly separated from the information referred
to in paragraph 1.

3.           The package leaflet shall
be written and designed to be clear and understandable, in terms that are
comprehensible to the general public.

Article 13
Package leaflet of homeopathic veterinary medicinal products

By way of derogation from Article 12(1),
the package leaflet for homeopathic veterinary medicinal products registered in
accordance with Articles 89 to 90 shall contain only the following information:

(a) 
the scientific name of the stock or stocks
followed by the degree of dilution, using the symbols of the European
Pharmacopoeia or, in the absence thereof, of the pharmacopoeias currently used
officially in Member States;

(b) 
name and address of the marketing authorisation
holder and, where appropriate, of the manufacturer;

(c) 
method of administration and, if necessary,
route;

(d) 
the expiry date, in the format
"mm/yyyy", preceded by the abbreviation "Exp.";

(e) 
pharmaceutical form;

(f) 
special storage precautions, if any;

(g) 
target species;

(h) 
a special warning if necessary for the medicinal
product;

(i) 
the batch number, preceded by the word "Lot";

(j) 
registration number;

(k) 
withdrawal period, if applicable.

(l) 
the statement "homeopathic veterinary
medicinal product".

Article 14
Languages

1.           The language or languages
of the information on the labelling shall be determined by Member State where the veterinary medicinal product is made available on the market.

2.           Member States shall
communicate the languages determined by them for the purpose of paragraph 1 to
the Commission. The Commission shall make this information public.

3.           Veterinary medicinal
products may be labelled in several languages.

Article 15
Abbreviations and pictograms common throughout the Union

The Commission shall, by means of implementing
acts, adopt a list of the abbreviations and pictograms common throughout the Union to be used for the purposes of Article 9(2) and Article 10(2). Those implementing
acts shall be adopted in accordance with the examination procedure referred to
in Article 145(2).

Section 5 
Dossier requirements for generic, combination and
hybrid veterinary medicinal products and for applications based on informed
consent and bibliographic data

Article 16
Generic veterinary medicinal products

1.           By way of derogation from
Article 7(1)(b), an application for a marketing authorisation for a generic
veterinary medicinal products shall not contain the documentation on safety and
efficacy if all the following conditions are fulfilled:

(a) 
the application satisfies the requirements set
out in Annex III;

(b) 
the applicant can demonstrate that the
application concerns a generic veterinary medicinal product of a veterinary
medicinal product which has been authorised by a Member State or by the
Commission, and the period of protection of the technical documentation in
respect of that reference veterinary medicinal product laid down in Articles 34
and 35 has elapsed or is due to elapse in less than 2 years (‘reference
veterinary medicinal product’);

(c) 
documentation referred to in Article 7(1)(b) is
available for the reference veterinary medicinal product to the competent
authority or to the Agency.

2.           For the purpose of this
Section, where the active substance consists of salts, esters, ethers, isomers
and mixtures of isomers, complexes or derivatives differing from the active
substance used in the reference veterinary medicinal product, it shall be
considered to be the same active substance as that used in the reference
veterinary medicinal product, unless it differs significantly in respect of
properties with regard to safety or efficacy. Where it differs significantly in
respect of those properties, the applicant shall submit additional information
in order to prove the safety and/or efficacy of the various salts, esters or
derivatives of the authorised active substance of the reference veterinary
medicinal product.

3.           Where the reference veterinary
medicinal product was not authorised in the Member State in which the
application for the generic medicinal product is submitted, or the application
is submitted in accordance with Article 38(3) where the reference medicinal
product was authorised in a Member State, the applicant shall indicate in its
application the Member State in which the reference veterinary medicinal
product has been authorised.

4.           The competent authority or
the Agency may request information on the reference veterinary medicinal
product from the competent authority of the Member State where it was
authorised. Such information shall be transmitted to the requestor within 30
days of receipt of the request.

5.           The summary of the product
characteristics of the generic veterinary medicinal product shall be identical
to that of the reference veterinary medicinal product. However, that
requirement shall not apply to those parts of the summary of the product
characteristics of the reference veterinary medicinal product that refer to
indications or pharmaceutical forms which are still covered by patent law at
the time when the generic veterinary medicinal product is authorised.

6.           A competent authority or
the Agency may require the applicant to provide safety data concerning the
potential risks posed by the generic veterinary medicinal product to the
environment in case the marketing authorisation for the reference veterinary
medicinal product was granted before 20 July 2000 or in case the second phase
environmental risk assessment was required for the reference veterinary
medicinal product.

7.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 146 concerning
amendments to Annex III in order to adapt the requirements to technical and
scientific progress.

Article 17
Combination veterinary medicinal products

By way of derogation from Article 7(1)(b)
an application for a marketing authorisation for a veterinary medicinal product
containing a combination of active substances that have each already been used
in authorised veterinary medicinal products, but have not hitherto been
authorised in that combination (‘combination veterinary medicinal product’) shall
satisfy the following criteria:

(a) 
the application satisfies the requirements set
out in Annex III;

(b) 
the applicant can demonstrate that the
veterinary medicinal product is a combination of reference veterinary medicinal
products as referred to in Article 16(1)(b);

(c) 
documentation referred to in Article 7(1)(b) is
available for the reference veterinary medicinal products to the competent
authority or to the Agency;

(d) 
documentation on the safety of that combination
is provided.

Article 18
Hybrid veterinary medicinal products

1.           By way of derogation from
Article 16(1), the results of appropriate pre-clinical studies and clinical
trials shall be required when the product does not meet all the characteristics
of a generic veterinary medicinal product because:

(a) 
there are changes in the active substance(s),
therapeutic indications, strength, pharmaceutical form or route of
administration of the generic veterinary medicinal product compared to the
reference veterinary medicinal product, or

(b) 
bioavailability studies cannot be used to
demonstrate bioequivalence with the reference veterinary medicinal product, or

(c) 
there are differences relating to raw materials
or in manufacturing processes of the biological veterinary medicinal product
and the reference biological veterinary medicinal product.

2.           The pre-clinical studies
or clinical trials may be conducted with batches of reference products manufactured
in the Union or in third countries.

When the batches are manufactured in third
countries, the applicant shall demonstrate by state of the art analytical tests
that the two reference products are so highly similar that they can substitute
to each other in the clinical trials.

Article 19
Application based on informed consent

By way of derogation from Article 16(1)(b),
an applicant for a marketing authorisation for a generic veterinary medicinal
product shall not be required to provide the documentation on safety and
efficacy if he demonstrates in the form of a letter of access that he is
allowed to use the documentation on safety and efficacy referred to in Article
7(1)(b) which is available for the reference veterinary medicinal product.

Article 20
Application based on bibliographic data

1.           By way of derogation from
Article 7(1)(b), the applicant shall not be required to provide the
documentation referred to therein if he demonstrates that the active substances
of the veterinary medicinal product have been in well-established veterinary
use within the Union for at least 10 years, that their efficacy is documented
and that they provide an acceptable level of safety.

2.           The application shall
satisfy the requirements set out in Annex III.

Section 6 
Dossier requirements for applications for limited market and in exceptional
circumstances

Article 21
Reduced data requirements for applications for limited markets

1.           By way of derogation from
Article 7(1)(b), a marketing authorisation for a veterinary medicinal product
intended for a limited market shall be granted although the quality and/or
efficacy documentation required in accordance with Annex II has not been
provided, if all the following conditions are met:

(a) 
the benefit of the immediate availability on the
market of the veterinary medicinal product to the animal or public health
outweighs the risk inherent in the fact that certain documentation has not been
provided;

(b) 
the applicant provides the evidence that the
veterinary medicinal product is intended for a limited market.

2.           By way of derogation from
Article 5(2), a marketing authorisation for a limited market shall be granted
for a period of 3 years.

3.           Where a medicinal product
has been granted a marketing authorisation in accordance with this Article, the
summary of product characteristics shall clearly state that only a limited
assessment of quality and/or efficacy has been conducted due to the lack of
comprehensive efficacy and/or quality data.

Article 22
Data requirements for applications in exceptional circumstances

1.           By way of derogation from
Article 7(1)(b), in exceptional circumstances related to animal or public
health, where the applicant has demonstrated that for objective, verifiable
reasons he is unable to provide the quality, safety and/or efficacy
documentation required in accordance with Part 1, Part 2 and Part 3 of Annex
II, a marketing authorisation may be granted subject to any of the following:

(a) 
a requirement to introduce conditions or
restrictions, in particular concerning the safety of the veterinary medicinal
product;

(b) 
a requirement to notify the competent
authorities of any incident relating to the use of the veterinary medicinal
product;

(c) 
a requirement to conduct post-authorisation
studies.

2.           By way of derogation from
Article 5(2), a marketing authorisation in exceptional circumstances shall be
granted for a period of 1 year.

3.           Where a medicinal product
has been granted a marketing authorisation in accordance with this Article, the
summary of product characteristics shall clearly state that only a limited
assessment of quality, safety and/or efficacy has been conducted due to the
lack of comprehensive quality, safety and/or efficacy data.

Section 7
Examination of applications and granting of marketing authorisations

Article 23
Examination of applications

1.           The competent authority or
the Agency to which the application has been submitted in accordance with
Article 6 shall:

(a) 
verify that the documentation submitted complies
with the requirements laid down in Article 7(1) and is satisfactory for
granting a marketing authorisation;

(b) 
assess the veterinary medicinal product
regarding the quality, safety and efficacy documentation provided.

2.           During the process of
assessing applications for marketing authorisations for veterinary medicinal
products containing or consisting of genetically modified organisms as referred
to in Article 7(5), the necessary consultations shall be held by the Agency
with the bodies set up by the Union or Member States in accordance with
Directive 2001/18/EC.

Article 24
Requests to laboratories in the course of the examination of applications

1.           The competent authority or
the Agency examining the application may require an applicant to provide
samples of the veterinary medicinal product to the Union reference laboratory,
an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose to:

(a) 
test the veterinary medicinal product, its
starting materials and if necessary intermediate products or other constituent
materials in order to ensure that the control methods employed by the
manufacturer and described in the application documents are satisfactory;

(b) 
verify, using samples provided by the applicant,
that the analytical detection method proposed by the applicant for the purposes
of safety tests and residue tests is satisfactory and suitable for use to
reveal the presence of residue levels, particularly those exceeding the maximum
residue level of the pharmacologically active substance established by the
Commission in accordance with Regulation (EC) No 470/2009 and Commission
Decision 2002/657/EC[25].

2.           The time limits laid down
in Articles 40, 44, 46 and 48 shall be suspended until the samples requested in
accordance with paragraph 1 have been provided.

Article 25
Information on manufacturers

The competent authority shall ascertain
that the manufacturers of veterinary medicinal products from third countries
are able to manufacture the veterinary medicinal product concerned and/or carry
out control tests in accordance with the methods described in the documentation
submitted in support of the application in accordance with Article 7(1).

Article 26
Information to the applicant

The competent authority or the Agency to
which the application has been submitted in accordance with Article 6 shall
inform the applicant if the documentation submitted in support of the
application is insufficient. The competent authority or the Agency shall
request the applicant to provide the documentation within a given deadline. In
such case the time limits laid down in Articles 40, 44, 46 and 48 shall be
suspended until the deadline has elapsed.

Article 27
Withdrawal of applications

1.           An applicant may withdraw
his application for marketing authorisation submitted to a competent authority
or the Agency at any time before the decision referred to in Article 31 or 32
has been taken.

2.           If an applicant withdraws
his application for marketing authorisation submitted to a competent authority
or the Agency before the assessment of the application as referred to in
Article 23 has been completed, the applicant shall communicate its reasons for
doing so to the competent authority or the Agency to which the application was
submitted in accordance with Article 6.

3.           If an assessment report
or, in case of the centralised authorisation procedure, the opinion, has been
drawn up, it shall be made public by the competent authorities or the Agency,
after deletion of any commercially confidential information.

Article 28
Outcome of the assessment

1.           In case of favourable
assessment to grant a marketing authorisation, the competent authority or the
Agency examining the application shall prepare an opinion including the
following documents:

(a) 
a summary of the product characteristics
containing the information laid down in Article 30;

(b) 
details of any conditions or restrictions to be
imposed as regards the supply or use of the veterinary medicinal product concerned,
including the classification of a veterinary medicinal product in accordance
with Article 29;

(c) 
details of any conditions or restrictions which
should be imposed as regards the safe and effective use of the veterinary medicinal
product;

(d) 
the approved text of the labelling and package
leaflet.

2.           Where the application
concerns a veterinary medicinal product for food-producing target species, the
competent authority or the Agency shall prepare a statement related to the
maximum residue levels of the pharmaceutical active substance in relation to
specific foodstuffs and species, as established by the Commission in accordance
with Regulation (EC) No 470/2009.

3.           Where the application
concerns an antimicrobial veterinary medicinal product, the competent authority
or the Commission may require the marketing authorisation holder to conduct
post-authorisation studies in order to ensure that the benefit-risk balance
remains positive with a view to the possible development of antimicrobial
resistance.

Article 29
Requirement for a veterinary prescription

1.           A competent authority or
the Commission shall classify the following veterinary medicinal products as
subject to veterinary prescription:

(a) 
veterinary medicinal products which contain
psychotropic drugs or narcotics, including those covered by the United Nations
Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol and
the United Nations Convention on Psychotropic Substances of 1971;

(b) 
veterinary medicinal products for food-producing
animals;

(c) 
antimicrobial veterinary medicinal products;

(d) 
products intended for treatments of pathological
processes which require a precise prior diagnosis or the use of which may have
effects which impede or interfere with subsequent diagnostic or therapeutic
measures;

(e) 
officinal formulae intended for food-producing
animals;

(f) 
veterinary medicinal products containing an
active substance that has been authorised for less than 5 years in the Union.

2.           A competent authority or
the Commission may classify a veterinary medicinal product as subject to
veterinary prescription where special precautions are contained in the summary
of product characteristics referred to in Article 30, and in particular
potential risks to:

(a) 
the target species,

(b) 
the person administering the products to the
animal,

(c) 
the environment.

3.           By the way of derogation
from paragraph 1, a competent authority or the Agency may not classify a
veterinary medicinal product as subject to veterinary prescription if all of
the following conditions are fulfilled:

(a) 
the administration of the veterinary medicinal
product is restricted to pharmaceutical forms requiring no particular knowledge
or skill in using the products;

(b) 
the veterinary medicinal product does not
present a direct or indirect risk, even if administered incorrectly, to the
animal(s) treated, to the person administering the product or to the
environment;

(c) 
the summary of the product characteristics of
the veterinary medicinal product does not contain any warnings of potential
serious side effects deriving from its correct use;

(d) 
neither the veterinary medicinal product nor any
other product containing the same active substance has previously been the
subject of frequent adverse event reporting;

(e) 
the summary of the product characteristics does
not refer to contraindications related to other veterinary medicinal products
commonly used without prescription;

(f) 
the veterinary medicinal product is not subject
to special storage conditions;

(g) 
there is no risk for public health as regards
residues in food obtained from treated animals even where the veterinary
medicinal products are used incorrectly;

(h) 
there is no risk to public or animal health as
regards the development of resistance to anthelmintic substances even where the
veterinary medicinal products containing those substances are used incorrectly.

Article 30
Summary of the product characteristics

1.           The summary of the product
characteristics referred to in Article 28(1)(a) shall contain the following
information:

(a) 
name of the veterinary medicinal product
followed by its strength and pharmaceutical form;

(b) 
qualitative and quantitative composition of the
active substances or other constituents stating the common name or the chemical
description of the substances or other constituents;

(c) 
clinical information:

(i) target species,

(ii) indications for use,

(iii) contra-indications,

(iv) special warnings for each target species,

(v)
special precautions for use, including special precautions to be taken by the
person administering the medicinal product to the animals,

(vi)
frequency and seriousness of adverse events,

(vii) use during pregnancy, lactation or lay,

(viii) interaction with other medicinal
products and other forms of interaction,

(ix) administration route and amounts to be
administered ,

(x)
overdose symptoms and emergency procedures and antidotes in the event of overdose,
where applicable,

(xi)
where appropriate, special indications or restrictions for use in accordance
with Articles 107 to 109,

(xii)
where appropriate, an indication of classification of an antimicrobial regarding
its strategic use,

(xiii)
special conditions for use, including restrictions on the use of antimicrobials
in order to limit the risk of development of antimicrobial resistance,

(d) 
withdrawal periods, including  animal
species/foodstuffs combinations;

(e) 
pharmacological information:

(i)
pharmacodynamics,

(ii)
pharmacokinetics,

(iii)
pharmaceutical particulars,

(iv)
major incompatibilities,

(v)
shelf life, where applicable after reconstitution of the medicinal product or
after the immediate packaging has been opened for the first time,

(vi)
special precautions for storage,

(vii)
nature and composition of immediate packaging,

(viii)
requirement to use take-back schemes for veterinary medicinal products for the
disposal of unused veterinary medicinal products or waste materials derived
from the use of such products and, if appropriate, additional precautions
regarding hazardous waste disposal of unused veterinary medicinal products or
waste materials derived from the use of such products;

(f) 
name of the marketing authorisation holder;

(g) 
marketing authorisation number(s);

(h) 
if applicable, date of the first authorisation;

(i) 
the date of the last revision of the summary of
the product characteristics;

(j) 
if applicable, for products authorised in
accordance with Article 21 or Article 22, the statement 'market authorisation
granted for a limited market/exceptional circumstances and therefore assessment
based on customised requirements for documentation'.

2.           In case of generic
veterinary medicinal products, the parts of the summary of the product
characteristics of the reference veterinary medicinal product that refer to
indications or pharmaceutical forms which are protected by patent law in a
Member State at the time of placing the generic veterinary medicinal product on
the market may be omitted.

Article 31
Decisions granting marketing authorisations

1.           Decisions granting
marketing authorisations shall be taken on the basis of the documents prepared
in accordance with Article 28 and shall set out the conditions attached to the
placing on the market of the veterinary medicinal product and the summary of
the product characteristics (‘terms of the marketing authorisation’).

2.           The competent authority or
the Commission shall make the decision granting the marketing authorisation publicly
available and record it in the database referred to in Article 51.

Article 32
Decisions refusing marketing authorisations

1.           The marketing
authorisation shall be refused on any of the following grounds:

(a) 
the benefit-risk balance of the veterinary medicinal
product is unfavourable;

(b) 
the applicant has not provided sufficient
information on the quality, safety or efficacy of the veterinary medicinal
product;

(c) 
the product is a zootechnical veterinary
medicinal product or a performance enhancer, and the applicant has not
sufficiently demonstrated the benefits of the product to the animal health and
welfare or public health;

(d) 
the product is an antimicrobial veterinary
medicinal product presented  for use as performance enhancer in order to
promote the growth of treated animals or to increase yields from treated
animals;

(e) 
the withdrawal period is not long enough to
ensure food safety;

(f) 
information to be provided in the immediate
packaging, the outer packaging and the package leaflet of the veterinary
medicinal product does not comply with the requirements set out in Articles 9
to 11;

(g) 
risk for public health in case of development of
antimicrobial resistance outweighs the benefits of the product to animal
health;

(h) 
the product has no therapeutic effect or the
applicant has not provided sufficient proof of such effect as regards the
target species;

(i) 
the qualitative or quantitative composition of
the product is not as stated in the application.

2.           A marketing authorisation
for an antimicrobial veterinary medicinal product shall be refused if the
antimicrobial is reserved for treatment of certain infections in humans.

3.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 146 in order to
establish rules for the designation of the antimicrobials which are to be
reserved for treatment of certain infections in humans in order to preserve the
efficacy of certain active substances in humans.

4.           The Commission shall, by
means of implementing acts, designate antimicrobials or groups of antimicrobials
reserved for treatment of certain infections in humans. Those implementing acts
shall be adopted in accordance with the examination procedure referred to in
Article 145(2).

Section 8
 Protection of technical documentation

Article 33
Protection of technical documentation

1.           Without prejudice to the
requirements and obligations laid down in Directive 2010/63/EU, technical
documentation on quality, safety and efficacy originally submitted with a view
to obtaining a marketing authorisation or a variation thereof shall not be used
by other applicants for a marketing authorisation or a variation of the terms
of a marketing authorisation for a veterinary medicinal product unless:

(a) 
the period of the protection of technical
documentation as set out in Articles 34 and 35 has elapsed, or

(b) 
the applicants have obtained written agreement
in the form of a letter of access with regard to that documentation.

2.           The protection of the technical
documentation as referred to in paragraph 1 ('the protection of technical
documentation') shall also apply in Member States where the product is not
authorised or is no longer authorised.

3.           Any marketing
authorisation or variation to the terms of a marketing authorisation differing
from the previously granted marketing authorisation only with regard to
strengths, pharmaceutical forms, administration routes or presentations shall
be regarded as the same marketing authorisation as the one previously granted
for the purpose of applying the rules of the protection of technical
documentation.

Article 34
Periods of the protection of technical documentation

1.           The period of the protection
of technical documentation shall be:

(a) 
10 years for the veterinary medicinal products
for cattle, sheep, pigs, chickens, dogs and cats;

(b) 
14 years for antimicrobial veterinary medicinal
products for cattle, sheep, pigs, chickens, dogs and cats containing an antimicrobial
active substance which has not been an active substance in a veterinary
medicinal product authorised within the Union on the date of the submission of
the application;

(c) 
18 years for veterinary medicinal products for
bees;

(d) 
14 years for veterinary medicinal products for
animal species other than listed in paragraph 1(a) and (c).

2.           The protection shall apply
from the day when the marketing authorisation for the veterinary medicinal
product was granted in accordance with Article 7.

Article 35
Prolongation of the periods of the protection of technical documentation

1.           Where a variation is
approved in accordance with Article 65 extending the marketing authorisation to
another species listed in Article 34(1)(a), the period of the protection
provided for in that Article shall be prolonged by 1 year for each additional
target species, provided that the variation has been submitted at least 3 years
before the expiration of the protection period laid down in Article 34(1)(a).

2.           Where a variation is
approved in accordance with Article 65 extending the marketing authorisation to
a another species not listed in Article 34(1)(a), the period of the protection
provided for in Article 34 shall be prolonged by 4 years.

3.           The period of the
protection of the first marketing authorisation prolonged by any additional
periods of protection due to any variations or new authorisations belonging to
the same marketing authorisation ('overall period of the protection of
technical documentation') shall not exceed 18 years.

4.           Where an applicant for a
marketing authorisation for a veterinary medicinal product or for a variation
to the terms of the marketing authorisation submits an application in
accordance with Regulation (EC) No 470/2009 for the establishment of a maximum
residue limit, together with clinical trials during the application procedure,
other applicants shall not use those trials for a period of 5 years from the granting
of the marketing authorisation for which they were carried out, unless the
other applicant has obtained written agreement in the form of a letter of
access with regard to those trials.

Article 36
Patent-related rights

Conducting the necessary studies, tests and
trials with a view to applying for a marketing authorisation in accordance with
Article 16 and the consequential practical requirements shall not be regarded
as contrary to patent-related rights or to supplementary-protection
certificates for medicinal products.

Chapter III
Procedures for granting marketing authorisations

Section 1
Marketing authorisations valid throughout the Union (‘centralised marketing authorisations’)

Article 38
Scope of the centralised marketing authorisation procedure

1.           Centralised marketing
authorisations shall be granted by the Commission in accordance with this
Section. They shall be valid throughout the Union.

2.           Centralised marketing
authorisation procedure shall apply in respect of the following veterinary
medicinal products:

(a) 
veterinary medicinal products developed by means
of one of the following biotechnological processes:

(i)         recombinant
DNA technology;

(ii)        controlled
expression of genes coding for biologically active proteins in prokaryotes and
eukaryotes including transformed mammalian cells;

(iii)       hybridoma
and monoclonal antibody methods;

(b) 
veterinary medicinal products intended primarily
for use as performance enhancers in order to promote the growth of treated
animals or to increase yields from treated animals;

(c) 
veterinary medicinal products containing an active
substance which has not been authorised as a veterinary medicinal product
within the Union at the date of the submission of the application;

(d) 
biological veterinary medicinal products which
contain or consist of engineered allogeneic tissues or cells;

(e) 
generic veterinary medicinal products of
reference veterinary medicinal products authorised under the centralised
authorisation procedure.

3.           For veterinary medicinal
products other than those listed in paragraph 2 a centralised marketing
authorisation may be granted if no other marketing authorisation has been
granted for the veterinary medicinal product within the Union.

4.           The Commission, taking
into account the state of animal and public health in the Union, shall be
empowered to adopt delegated acts in accordance with Article 146 in order to
amend the list set out in paragraph 2.

Article 39
Application for centralised marketing authorisation

1.           Applications for
centralised marketing authorisations shall be submitted to the Agency. The
application shall be accompanied by the fee payable to the Agency for the
examination of the application.

2.           The application for a
centralised authorisation of veterinary medicinal product shall state a single
name for the veterinary medicinal product to be used throughout the Union.

3.           Translations of the
labelling, package leaflet and the summary of the product characteristics shall
be submitted in the languages determined by the Member States in accordance
with Article 14.

Article 40
Procedure for centralised marketing authorisation

1.           Centralised marketing
authorisations shall be granted by the Commission following an assessment by
the Agency.

2.           As an outcome of the
assessment of an application for marketing authorisation for a veterinary
medicinal product, the Agency shall draw up an opinion as referred to in
Article 28.

3.           The opinion shall be given
within 210 days of receipt of a valid application. Exceptionally, where a
particular expertise is required, the deadline may be extended by a maximum of
90 days.

4.           When an application is
submitted for a marketing authorisation in respect of veterinary medicinal
products of major interest, particularly from the point of view of animal
health and therapeutic innovation, the applicant may request an accelerated
assessment procedure. The request shall be duly substantiated. If the Agency
accepts the request, the time limit of 210 days shall be reduced to 150 days.

5.           The opinion of the Agency
shall be forwarded to the applicant. Within 15 days of receipt of the opinion
the applicant may provide written notice to the Agency that he wishes to
request a re-examination of the opinion. In such case, Article 41 shall apply.

6.           After the completion of
the procedure referred to in paragraph 5 the opinion shall be forwarded without
delay to the Commission.

7.           The Commission may request
clarifications from the Agency as regards the content of the opinion, in which
case the Agency shall provide a response to this request within 90 days.

8.           Within 15 days of receipt
of the opinion, the Commission shall prepare a draft of the decision to be
taken in respect of the application. Where a draft decision envisages granting
of a marketing authorisation, it shall include or make reference to the
documents listed in Article 28. Where the draft decision is not in accordance
with the opinion of the Agency, the Commission shall annex a detailed
explanation of the reasons for the differences. The draft decision shall be
forwarded to Member States and the applicant.

9.           The Commission shall, by
means of implementing acts, take a final decision on the granting of a centralised
marketing authorisation. Those implementing acts shall be adopted in accordance
with the examination procedure referred to in Article 145(2).

10.         The Agency shall
disseminate the documents referred to in Article 28 to the applicant.

11.         The Agency shall make the
opinion publicly available, after deleting any commercially confidential
information.

Article 41
Re-examination of the opinion of the Agency

1.           Where the applicant
requests a re-examination of the opinion in accordance with Article 40(5), he
shall forward to the Agency detailed grounds for the request within 60 days
after receipt of the opinion.

2.           Within 60 days after receipt
of the grounds for the request, the Agency shall re-examine its opinion. The
reasons for the conclusions reached shall be annexed to the opinion.

3.           Within 15 days after its
adoption, the Agency shall forward its opinion to the Commission and the applicant.

Section 2
 Marketing authorisations valid in a single Member State (‘national marketing
authorisation’)

Article 42
Scope of national marketing authorisation

National marketing authorisations shall be
granted by the competent authorities in accordance with this Section and
applicable national provisions. A national marketing authorisation shall be
valid in the Member State which granted it.

National marketing authorisations shall
only be granted in respect of veterinary medicinal products not falling within
the scope of Article 38(2).

Article 43
Applications for national marketing authorisations

Competent authorities shall verify whether
an application for a national marketing authorisation has been submitted or
granted for the same veterinary medicinal product in another Member State. Where that is the case, the competent authority of that Member State shall decline to assess the application and inform the applicant of the possibility to
submit an application under the mutual recognition procedure or the
decentralised authorisation procedure.

Article 44
Procedure for national marketing authorisation

1.           The procedure for granting
a national marketing authorisation for a veterinary medicinal product shall be
completed within a maximum of 210 days after the submission of the complete
application.

2.           Competent authorities
shall make the assessment report publicly available, after deleting any
commercially confidential information.

Section 3
Marketing authorisations valid in several Member States (‘decentralised
marketing authorisations’)

Article 45
Scope of decentralised marketing authorisation

1.           Decentralised marketing
authorisations shall be granted by the competent authorities in accordance with
this Section. They shall be valid in the Member States stated therein.

2.           Decentralised marketing
authorisations shall only be granted in respect of veterinary medicinal
products for which no national marketing authorisation has been granted at the
time of application for a decentralised marketing authorisation and which does
not fall within the scope of Article 38(2).

Article 46
Procedure for decentralised marketing authorisation

1.           Applications for
decentralised marketing authorisation shall be submitted to the Member State chosen by the applicant (‘reference Member State’).

2.           The application shall list
Member States where the applicant seeks to obtain a marketing authorisation
(‘Member States concerned’).

3.           Within 120 days of receipt
of a valid application, the reference Member State shall prepare an assessment
report. The assessment report together with the approved summary of the product
characteristics and text to appear in the labelling and package leaflet shall
be forwarded to all Member States and the applicant, together with the list of
the Member States concerned.

4.           Within 90 days after
receipt of the documents referred to in paragraph 3, Member States shall
examine the assessment report, the summary of the product characteristics, the
labelling and the package leaflet and inform the reference Member State of
whether they have no objections to the assessment report, summary of product
characteristics, labelling and package leaflet.

5.           Where all Member States
agree, the reference Member State shall record the agreement, close the
procedure and inform the applicant and the Member States accordingly. Each Member State from the list referred to in paragraph 2 shall grant a marketing authorisation in
conformity with the approved assessment report, summary of the product
characteristics, labelling and package leaflet within 30 days of the receipt of
the information regarding the agreement from the reference Member State.

6.           If at any stage of the
procedure a Member State concerned invokes the reasons referred to in Article 113(1)
for prohibiting the veterinary medicinal product it shall no longer be
considered as a Member State where the applicant seeks to obtain a marketing
authorisation. However, a Member State having invoked those reasons may
subsequently recognise the marketing authorisation in accordance with Article 57.

7.           Competent authorities
shall make the assessment report publicly available, after deleting any
commercially confidential information.

Section 4
 Mutual recognition of marketing authorisations granted by national authorities

Article 47
Scope of mutual recognition marketing authorisation

A national marketing authorisation for a
veterinary medicinal product shall be recognised by other Member States in
accordance with the procedure laid down in Article 48.

Article 48
Procedure for mutual recognition marketing authorisation

1.           Applications for mutual
recognition of marketing authorisations shall be submitted to the Member State that granted the first national marketing authorisation ("reference Member State").

2.           A minimum of 6 months shall
elapse between the decision granting the first national marketing authorisation
and the submission of the application for mutual recognition of the national
marketing authorisation.

3.           An application for mutual
recognition of a marketing authorisation shall be accompanied by the following:

(a) 
an information about the Member States where the
applicant seeks to obtain recognition of the marketing authorisation;

(b) 
copies of marketing authorisations granted for
the veterinary medicinal product in other Member States;

(c) 
an information about the Member States in which
an application for a marketing authorisation submitted by the applicant for the
same veterinary medicinal product is under examination;

(d) 
a summary of the product characteristics
proposed by the applicant;

(e) 
the text to appear in the labelling and package
leaflet;

(f) 
information on refusals to grant a marketing
authorisation in the Union or in a Member State or in a third country and the
reasons for the refusal.

4.           Within 90 days of receipt
of a valid application, the reference Member State shall prepare an updated
assessment report for the veterinary medicinal product. The updated assessment
report together with the approved summary of the product characteristics and
the text to appear in the labelling and package leaflet shall be forwarded to
all Member States and the applicant, together with the list of Member States
where the applicant seeks to obtain recognition of the marketing authorisation
(‘concerned Member States’).

5.           Within 90 days after
receipt of the documents referred to in paragraph 3, Member States shall
examine the assessment report, the summary of the product characteristics, the
labelling and the package leaflet and inform the reference Member State of
whether it has no objections to the assessment report, summary of product
characteristics, labelling and package leaflet.

6.           Where all Member States
agree, the reference Member State shall record the agreement, close the
procedure and inform the applicant and the Member States accordingly. Each Member State referred to in paragraph 3 shall grant a marketing authorisation in conformity
with the approved assessment report, summary of the product characteristics,
labelling and package leaflet within 30 days of the receipt of the information
regarding the agreement from the reference Member State.

7.           If at any stage of the
procedure a concerned Member State invokes the reasons referred to in Article
113(1) for prohibiting the veterinary medicinal product, it shall no longer be
considered as a Member State where the applicant seeks to obtain a marketing
authorisation. However, a Member State having invoked those reasons may
subsequently recognise the marketing authorisation in accordance with Article
57.

8.           Competent authorities
shall make the assessment report publicly available, after deleting any
commercially confidential information.

Section 5
Coordination group review and scientific re-examination

Article 49
Coordination group review procedure

1.           If a Member State raises,
within the time period referred to in Article 46(4) or Article 48(5) its
objections to the assessment report, proposed summary of product
characteristics or proposed labelling and package leaflet, a detailed statement
of the reasons shall be provided to the reference Member State, the other
Member States and the applicant. The points of disagreement shall be referred
without delay to the coordination group for mutual recognition and
decentralised procedures set up by Article 142(‘the coordination group’) by the
reference Member State.

2.           Within the coordination
group, a rapporteur shall be appointed in order to prepare a second assessment
report for the veterinary medicinal product.

3.           The second assessment
report shall be presented by the rapporteur to the coordination group within
the period of 90 days. Upon presentation of the second assessment report, the
coordination group shall adopt an opinion by a majority of the votes cast by
the members of the coordination group represented at the meeting.

4.           In the event of an opinion
in favour of granting a marketing authorisation, the reference Member State shall record the agreement of Member States, close the procedure and inform Member States and the applicant accordingly.

5.           Each Member State
concerned shall grant a marketing authorisation in conformity with the
agreement within 30 days of receipt of the information regarding the agreement
from the reference Member State.

6.           In the event of an
unfavourable opinion, the marketing authorisation shall be refused by each Member State concerned within 30 days of acknowledgement of the agreement. The scientific
conclusions and grounds for revocation of the marketing authorisation shall be
annexed to the unfavourable opinion.

Article 50
Request for scientific re-examination

1.           Within 15 days after
receipt of the assessment report referred to in Article 46(3) or in Article
48(4) the applicant may provide written notice to the Agency requesting a
re-examination of the assessment report. In that case the applicant shall
forward to the Agency detailed grounds for the request within 60 days of
receipt of the assessment report. The application shall be accompanied by proof
of payment of the fee payable to the Agency for the re-examination.

2.           Within 120 days of receipt
of the grounds for the request, the Committee for Medicinal Products for
Veterinary Use set up by Article 139 (‘the Committee’) shall re-examine the
assessment report. The reasons for the conclusion reached shall be annexed to
the opinion.

3.           The re-examination
procedure shall deal only with the points of the assessment report identified
by the applicant in the written notice.

4.           Within 15 days of its
adoption, the Agency shall forward the opinion of the Committee to the
coordination group, together with a report describing the assessment of the
veterinary medicinal product by the Committee and stating the reasons for its
conclusions. Those documents shall be forwarded to the Commission, to Member
States and to the applicant for information purposes.

5.           Upon presentation of the
Agency's opinion, the coordination group shall act by the majority of the votes
cast by its members represented at the meeting. The reference Member State shall record the agreement, close the procedure and inform the applicant. Article 49
shall apply accordingly. Where the decision is not in accordance with the
opinion of the Agency, the coordination group shall annex a detailed
explanation of the reasons for the differences.

Chapter IV
Post marketing authorisation measures

Section 1
 Union product database

Article 51
Union database on veterinary medicinal products

1.           A Union database on
veterinary medicinal products (‘product database’) shall be set up and
maintained by the Agency.

2.           The product database shall
contain information on:

(a) 
veterinary medicinal products authorised within
the Union by the Commission and by the competent authorities, together with
their summaries of product characteristics, package leaflets and lists of sites
where each product is manufactured;

(b) 
homeopathic veterinary medicinal products
registered within the Union by the Commission and by the competent authorities,
together with their package leaflet and lists of sites where each product is
manufactured;

(c) 
veterinary medicinal products allowed to be used
in a Member State in accordance with Articles 119 and 120.

3.           Within 12 months from the
date of the entry into force of this Regulation, the Agency shall make public a
format for electronic submissions of information on marketing authorisations of
veterinary medicinal products granted by the competent authorities.

4.           The competent authorities
shall submit information on marketing authorisations granted by them to the
product database, using the format referred to in paragraph 3.

5.           The Agency shall submit
information on marketing authorisations granted by the Commission to the
product database, using the format referred to in paragraph 3.

6.           Within 12 months from the
date of application of this Regulation, the competent authorities shall submit
electronically information on all veterinary medicinal products authorised in
their Member State before the date of application of this Regulation to the
Agency, using the format referred to in paragraph 3.

7.           The Agency shall, in
collaboration with Member States and the Commission, draw up the functional
specifications for the product database.

8.           The Commission shall
ensure that information reported to the product database is collected, collated
and made accessible and that the information is shared.

Article 52
Access to the product database

1.           The competent authorities,
the Agency and the Commission shall have full access to the information in the
product database.

2.           Marketing authorisation
holders shall have full access to the information in the product database
concerning their own marketing authorisations.

3.           The general public shall
have access to information in the product database as regards the list of the
authorised veterinary medicinal products, their summaries of product
characteristics and package leaflets.

Section 2
 Placing on the market

Article 53
Placing on the market

1.           Marketing authorisation
holders shall record in the product database the dates when their authorised
veterinary medicinal products are placed on the market in a Member State.

2.           Generic veterinary
medicinal products shall not be placed on the market until the period of the protection
of technical documentation for the reference veterinary medicinal product as
set out in Articles 34 and 35 has elapsed.

Article 54
Collection of data on the sales and use of antimicrobial veterinary medicinal
products

1.           Member States shall
collect relevant and comparable data on the volume of sales and the use of
veterinary antimicrobial medicinal products.

2.           Member States shall send
data on the volume of sales and the use of veterinary antimicrobial medicinal
products to the Agency. The Agency shall analyse the data and publish an annual
report.

3.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 146 in order to
establish detailed rules on the methods of gathering data on the use of
antimicrobials and the method of transfer of these data to the Agency.

4.           The Commission may, by
means of implementing acts, set up the format and the requirements for the data
to be collected in accordance with this Article. Those implementing acts shall
be adopted in accordance with the examination procedure referred to in Article
145(2).

Article 55
Responsibilities of the marketing authorisation holders

1.           In respect of the
manufacturing process and control methods stated in the application for a
marketing authorisation for the veterinary medicinal product and in order to
take account of scientific and technical progress, the marketing authorisation
holders shall ensure that any changes that may be required to enable that
veterinary medicinal product to be manufactured and verified by means of
generally accepted scientific methods are introduced. The introduction of such
changes shall be subject to the procedures laid down in Section 4 of this
Chapter.

2.           Competent authorities may
require marketing authorisation holders to provide them with sufficient
quantities of the veterinary medicinal products to enable controls to be made
on the identification of the presence of residues of the veterinary medicinal
products in question.

3.           Upon request of a
competent authority, the marketing authorisation holder shall provide technical
expertise to facilitate the implementation of the analytical method for
detecting residues of the veterinary medicinal products in the national reference
laboratory designated under Council Directive 96/23/EC[26].

4.           In order to permit
continuous assessment of the benefit-risk balance, a competent authority or the
Agency may at any time ask the marketing authorisation holder to forward data
demonstrating that the benefit-risk balance remains favourable.

5.           The marketing
authorisation holder shall without delay inform the competent authority or the
Commission of any prohibition or restriction imposed by a competent authority
and of any other new information which might influence the assessment of the
benefits and risks of the veterinary medicinal product concerned.

6.           Upon request from a
competent authority, the Commission or the Agency, the marketing authorisation
holder shall provide the competent authority, the Commission or the Agency with
all data in his possession relating to the volume of sales.

Article 56
National helpdesks for small and medium-sized enterprises

1.           In order to help small and
medium-sized enterprises to comply with the requirements of this Regulation,
Member States shall establish national helpdesks.

2.           National helpdesks shall
provide advice to applicants, marketing authorisation holders, manufacturers,
importers and any other interested parties which are small or medium-sized enterprises
on their responsibilities and obligations under this Regulation and on
applications for the authorisation of veterinary medicinal products.

Section 3
Subsequent recognition in the mutual recognition and decentralised marketing
authorisation procedures

Article 57
Subsequent recognition of marketing authorisations by other Member States

1.           After completion of a
mutual recognition procedure laid down in Article 48 or a decentralised
procedure laid down in Article 46, the marketing authorisation holder may
submit an application for a marketing authorisation for a veterinary medicinal
product to additional Member States. The application shall include the
following:

(a) 
a list of all decisions granting marketing
authorisations concerning this veterinary medicinal product;

(b) 
a list of variations introduced since the first
marketing authorisation in the Union was granted;

(c) 
a summary report on pharmacovigilance data.

2.           The additional Member State shall adopt a decision granting a marketing authorisation in conformity with
the assessment report referred to in Articles 46(3) and 48(4) or, where
appropriate, an updated assessment report, summary of the product
characteristics, labelling and package leaflet within 30 days of receipt of the
documents listed in paragraph 1.

3.           Paragraphs 1 and 2 shall
not apply to veterinary medicinal products that have been authorised through a
mutual recognition or decentralised procedure before the date of the
application of this Regulation.

4.           Recognition of marketing
authorisations for those veterinary medicinal products shall be granted in
accordance with the procedure laid down in Article 48.

Section 4
Changes to marketing authorisations

Article 58
Variations to the terms of a marketing authorisation

1.           Variation to the terms of
a marketing authorisation means a change to the terms of the marketing
authorisation for a veterinary medicinal product as referred to in Article 31
(‘variation’).

2.           The Commission shall, by
means of implementing acts, establish a list of variations to the terms of a
marketing authorisation for a veterinary medicinal product requiring assessment
(‘variations requiring assessment’). Those implementing acts shall be adopted
in accordance with the examination procedure referred to in Article 145(2).

3.           The Commission shall take
account of the following criteria when adopting those implementing acts:

(a) 
the need for a scientific assessment of changes
in order to determine the risk to public health, animal health or the
environment;

(b) 
whether changes have an impact on the safety and
efficacy of the veterinary medicinal product;

(c) 
whether changes imply a significant alteration
to the summary of product characteristics.

Article 59
Consequential changes to product information

Where a variation entails consequential changes
to the summary of the product characteristics, the labelling or the package
leaflet, those changes shall be considered as part of that variation for the
purposes of the examination of the application for a variation.

Article 60
Variations to the terms of a marketing authorisation that do not require
assessment

1.           Where a variation does not
appear in the list established in accordance with Article 58(2), the marketing
authorisation holder shall record the change in the product database within 12
months following the implementation of the variation.

2.           If necessary, competent
authorities or, where the veterinary medicinal product is authorised under the
centralised marketing authorisation procedure, the Commission shall amend the
decision granting a marketing authorisation in accordance with the change.

Article 61
Application for variations requiring assessment

1.           Marketing authorisation
holder shall submit an application for a variation requiring assessment to a
competent authority or to the Agency.

2.           The application referred
to in paragraph 1 shall contain:

(a) 
a description of the variation;

(b) 
reference to marketing authorisations affected
by the application;

(c) 
where the variation leads to other variations to
the terms of the same marketing authorisation, a description of those other
variations;

(d) 
where the variation concerns marketing
authorisations granted under the mutual recognition or decentralised
procedures, a list of Member States which granted those marketing
authorisations.

Article 62
Groups of variations

When applying for several variations to the
terms of the same marketing authorisation, a marketing authorisation holder may
submit one application for all variations.

Article 63
Worksharing procedure

1.           When applying for
variations to the terms of several marketing authorisations held by the same
marketing authorisation holder and granted by different competent authorities
and/or the Commission, the marketing authorisation holder shall submit an
application to all competent authorities concerned and the Agency.

2.           Where one of the marketing
authorisations referred to in paragraph 1 is a centralised marketing
authorisation, the Agency shall assess the application in accordance with the
procedure laid down in Article 64.

3.           Where none of the
marketing authorisations referred to in paragraph 1 is a centralised marketing
authorisation, the coordination group shall assign a competent authority among
those having granted the marketing authorisations to assess the application in
accordance with the procedure laid down in Article 64.

Article 64
Procedure for variations requiring assessment

1.           If a variation application
fulfils the requirements laid down in Article 61, the competent authority or
the Agency, or a competent authority assigned in accordance with Article 63(3)
shall acknowledge receipt of a complete application.

2.           If the application is
incomplete, the competent authority or the Agency, or a competent authority
assigned in accordance with Article 63(3) shall require the applicant to
complete the application within a reasonable deadline.

3.           The competent authority or
the Agency, or a competent authority assigned in accordance with Article 63(3)
shall assess the application and prepare an opinion on the variation within 60
days following the receipt of a valid application. However, where it is
necessary having regard to the urgency of the matter, the opinion shall be
adopted without delay.

4.           Within the period referred
to in paragraph 3, the competent authority or the Agency may require the
applicant to provide supplementary information within a set time limit. The
procedure shall be suspended until the supplementary information has been
provided.

5.           The opinion shall be
forwarded to the applicant.

6.           Where the opinion is
prepared by the Agency, the opinion shall be forwarded to the Commission. Where
the Agency assesses the application in accordance with Article 63(2), the
opinion shall be forwarded to the Commission and all competent authorities
concerned.

7.           Where the opinion is
prepared by a competent authority assigned in accordance with Article 63(3),
the opinion shall be forwarded to all competent authorities concerned.

8.           Within 15 days of receipt
of the opinion, the applicant may submit a written request to the Agency or the
competent authority for a re-examination of the opinion. Detailed grounds for
requesting a re-examination shall be stated in the request or be forwarded to
the Agency or to the competent authority within 60 days of receipt of the
opinion.

9.           Within 60 days of receipt
of the grounds for the request, the Agency or the competent authority shall re-examine
the points of the opinion identified in the request for re-examination by the
applicant and adopt a re-examined opinion. The reasons for the conclusions
reached shall be annexed to the opinion.

Article 65
Measures to close the procedures for variations requiring assessment

1.           Within 30 days of the
completion of the procedure laid down in Article 64(6) and (7) a competent
authority or the Commission shall amend the marketing authorisation or reject
the variation and inform the applicant of the grounds for the rejection. In
case of centralised marketing authorisation, the Commission shall, by means of
implementing acts, take a final decision amending the marketing authorisation
or rejecting the variation. These implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 145(2).

2.           Where the draft decision
is not in accordance with the opinion of the Agency, the Commission shall annex
a detailed explanation of the reasons for not following the opinion of the
Agency.

3.           The competent authority or
the Agency shall notify the marketing authorisation holder of the amended
marketing authorisation without delay.

4.           The product database shall
be updated accordingly.

Article 66
Coordination group review

Where the opinion is prepared by a
competent authority assigned in accordance with Article 63(3), each competent
authority concerned shall amend the marketing authorisation granted by it or reject
the variation in line with the opinion prepared by the competent authority
assigned in accordance with Article 63(3).

However, if a competent authority does not
agree with the opinion, the coordination group review procedure laid down in
Article 49 shall apply.

Article 67
Implementation of variations requiring assessment

1.           A marketing authorisation
holder may implement a variation requiring assessment only after a competent
authority or the Commission has amended the decision granting the marketing authorisation
in accordance with that variation and the holder has been notified thereof.

2.           Where
requested by a competent authority or the Agency, a marketing authorisation
holder shall supply without delay any information related to a variation to the
terms of a marketing authorisation.

Section 5 
Harmonisation of the summaries of the product characteristics for nationally
authorised products

Article 68
Preparatory phase of the harmonisation exercise

1.           A harmonised summary of
product characteristics shall be prepared in accordance with the procedure laid
down in Article 69 for veterinary medicinal products, other than homeopathic
veterinary medicinal products, which have the same qualitative and quantitative
composition of their active substances and the same pharmaceutical form and for
which national marketing authorisations have been granted in different Member
States before 1 January 2004 (‘similar products’).

2.           For the purposes of
determining qualitative and quantitative composition of the active substances,
different salts, esters, ethers, isomers, mixtures of isomers, complexes and
derivatives of an active substance shall be considered to be the same active
substance, unless they differ significantly in properties with regard to safety
or efficacy.

Article 69
Procedure for harmonisation of summaries of products characteristics

1.           By [12 months after the
date of application of this Regulation for OP to insert the actual date] competent
authorities shall provide the coordination group with lists of all products for
which national marketing authorisations have been granted before 1 January
2004.

2.           The coordination group
shall establish groups of similar products. For each of the groups of similar
products, the coordination group shall appoint one member to act as a
rapporteur.

3.           Within 120 days of his
appointment, the rapporteur shall present the coordination group a report
regarding possible harmonisation of summaries of product characteristics for
the similar veterinary medicinal products in the group and propose a harmonised
summary of products characteristics.

4.           Harmonised summaries of
product characteristics for veterinary medicinal products shall contain all of
the following information:

(a) 
all species mentioned in the marketing
authorisations granted by Member States in respect of the similar products in
the group;

(b) 
all therapeutic indications mentioned in the
marketing authorisations granted by Member States in respect of the similar
products in the group;

(c) 
the shortest withdrawal period of those stated
in the summaries of the product characteristics.

5.           Upon presentation of a
report, the coordination group shall act by a majority of the votes cast by the
members of the coordination group represented at the meeting. The rapporteur
shall record the agreement, close the procedure and inform Member States and the marketing authorisation holders accordingly.

6.           In the event of an opinion
in favour of adopting a harmonised summary of the product characteristics, each
  Member State shall vary a marketing authorisation in conformity with the
agreement within 30 days of receipt of the information regarding the agreement
from the rapporteur.

7.           In the event of an
unfavourable opinion, the procedure referred to in Article 49 shall apply.

Article 70
Harmonisation of summary of products characteristics following reassessment

1.           By way of derogation from
Article 69, the Committee may recommend to the Commission groups of similar
veterinary medicinal products for which a scientific reassessment is necessary
before a harmonised summary of the product characteristics is prepared.

2.           The Commission shall, by
means of implementing acts, adopt decisions on groups of product for which a
reassessment is necessary. Those implementing acts shall be adopted in accordance
with the examination procedure referred to in Article 145(2).

3.           By way of derogation from
Article 69, veterinary medicinal products authorised before 20 July 2000 as
well as veterinary medicinal products authorised after that date but which were
identified as potentially harmful to the environment in the course of the
environmental risk assessment shall be reassessed before a harmonised summary
of the product characteristics is prepared.

4.           For the purposes of
paragraphs 1 and 3, the procedure for a Union interest referral in accordance
with Articles 84 to 87 shall apply accordingly.

Article 71
Position of marketing authorisation holder

Upon request from the coordination group or
the Agency, holders of the marketing authorisations for products included in a
group of similar products identified for a harmonisation of the summaries of
the product characteristics shall submit information concerning their products.

Section 6
Pharmacovigilance

Article 72
Pharmacovigilance system of the marketing authorisation holder

1.           Marketing authorisation
holders shall elaborate and maintain a system for collecting information on the
risks of veterinary medicinal products as regards animal health, public health
and the environment enabling them to fulfil their pharmacovigilance
responsibilities listed  in Articles 73, 76 and 77 (‘pharmacovigilance
system’).

2.           Competent authorities and
the Agency shall supervise the pharmacovigilance systems of marketing
authorisation holders.

Article 73
Union pharmacovigilance system

1.           Member States, the
Commission, the Agency and marketing authorisation holders shall collaborate in
setting up and maintaining a system to monitor the safety of authorised
veterinary medicinal products, enabling them to fulfil their responsibilities
as listed in Articles 77 and 79 (‘Union pharmacovigilance system’).

2.           Competent authorities, the
Agency and marketing authorisation holders shall make available to healthcare
professionals and animal holders different means of reporting to them the
following events whether or not the event is considered to be product-related
(‘adverse events’):

(a) 
any response in an animal to a veterinary or
human medicinal product,  that is  noxious and unintended;

(b) 
any observation of a lack of efficacy of a
veterinary medicinal product following administration to an animal in
accordance with the summary of product characteristics;

(c) 
any environmental incidents observed following
administration of a veterinary medicinal product to an animal;

(d) 
any infringements of withdrawal period following
administration to an animal of a veterinary or human medicinal product;

(e) 
any noxious response in humans to a veterinary
medicinal product;

(f) 
any finding of an active substance in a produce
of a food-producing animal exceeding the levels of residues established in
accordance with Regulation (EC) No 470/2009.

Article 74
Union pharmacovigilance database

1.           The Agency shall establish
and maintain a Union database on pharmacovigilance of veterinary medicinal
products (the "pharmacovigilance database").

2.           The Agency shall, in
collaboration with the Member States and the Commission, draw up the functional
specifications for the pharmacovigilance database.

3.           The Agency shall ensure
that information reported to the pharmacovigilance database is uploaded and
made accessible in accordance with Article 75.

Article 75
Access to the pharmacovigilance database

1.           The competent authorities
shall have full access to the pharmacovigilance database.

2.           Marketing authorisation
holders shall have access to the pharmacovigilance database to the extent
necessary for them to comply with their pharmacovigilance responsibilities as
specified in Article 77.

3.           The general public shall
have access to the pharmacovigilance database only as regards the following
information:

(a) 
the number of adverse events reported each year,
broken down by product, animal species and type of adverse event;

(b) 
information on the process and outcome of the
signal management referred to in Article 81 for veterinary medicinal products
and groups of products.

Article 76
Adverse events reporting

1.           Competent authorities
shall record in the pharmacovigilance database all adverse events which were
reported to them by healthcare professionals and animal holders and that
occurred in the territory of their Member State, within 30 days following the
receipt of the adverse event report.

2.           Marketing authorisation
holders shall record in the pharmacovigilance database all adverse events which
were reported to them by healthcare professionals and animal holders and that
occurred within the Union or in a third country with regard to their authorised
veterinary medicinal products, within 30 days following the receipt of the
adverse event report.

3.           Competent authorities may,
on their own initiative or on request from the Agency, request the marketing
authorisation holder to collect specific pharmacovigilance data, in particular
regarding the use of a veterinary medicinal product in specified animal
species, in the context of public and animal health, safety of the persons
administering the product, and the protection of the environment. The authority
shall state in detail the reasons for the request and inform other competent
authorities and the Agency thereof.

4.           Within 15 days after
receipt of the request referred to in paragraph 3, the marketing authorisation
holder may give written notice to the competent authority that he wishes a
re-examination of the request to collect additional specific pharmacovigilance
data.

5.           Within 60 days following
the receipt of the written notice, the competent authority shall re-examine the
request and provide the marketing authorisation holder with its decision.

Article 77
Pharmacovigilance responsibilities of the marketing authorisation holder

1.           The marketing
authorisation holder shall be responsible for the pharmacovigilance of the
products for which he holds a marketing authorisation.

2.           Where the
pharmacovigilance tasks have been contracted out by the marketing authorisation
holder to a third party, those arrangements shall be set out in details in the
pharmacovigilance system master file.

3.           The marketing
authorisation holder shall permanently have at his disposal one or more
appropriately qualified persons responsible for pharmacovigilance. Those
persons shall reside and operate in the Union. Only one qualified person shall
be designated by the marketing authorisation holder per pharmacovigilance
system master file.

4.           Where the tasks of the
qualified person responsible for pharmacovigilance listed in Article 78 have
been contracted out to a third party, those arrangements shall be detailed in
the contract.

5.           The marketing
authorisation holder shall, based on pharmacovigilance data and where
necessary, submit changes to the terms of a marketing authorisation in
accordance with Article 61.

6.           The marketing
authorisation holder shall not communicate information regarding adverse events
to the general public in relation to the veterinary medicinal product without
giving prior notification of his intention to the competent authority or
authorities having granted the marketing authorisation or to the Agency where
the marketing authorisation was granted in accordance with the centralised
authorisation procedure.

Where the marketing authorisation holder
communicates such information to the general public, he shall ensure that it is
presented objectively and is not misleading.

Article 78
Qualified person responsible for pharmacovigilance

Qualified persons responsible for
pharmacovigilance as referred to in Article 77(3) shall carry out the following
tasks:

(a) 
elaborating and maintaining a detailed
description of the pharmacovigilance system used by the marketing authorisation
holder with respect to the veterinary medicinal product for which the
authorisation has been granted (‘pharmacovigilance system master file’) for all
products under their responsibility;

(b) 
allocating reference numbers to the
pharmacovigilance system master file and communicating the reference number of
the pharmacovigilance master file of each product  to the product database;

(c) 
notifying the competent authorities and the
Agency of the place where the qualified person operates and  where the
pharmacovigilance system master file is accessible in the Union;

(d) 
establishing and maintaining a system which
ensures that all adverse events which are brought to the attention of the
marketing authorisation holder are collected and recorded in order to be
accessible at least at one site in the Union;

(e) 
preparing the adverse event reports referred to
in Article 76;

(f) 
ensuring that collected adverse event reports
are recorded in the pharmacovigilance database;

(g) 
ensuring that any request from the competent
authorities or the Agency for the provision of additional information necessary
for the evaluation of the benefit-risk balance of  a veterinary medicinal
product is answered fully and promptly, including providing information about
the volume of sales or prescriptions of the veterinary medicinal product
concerned;

(h) 
providing competent authorities or the Agency
with any other information relevant to detecting a change to the benefit-risk
balance of a veterinary medicinal product, including appropriate information on
post-marketing surveillance studies;

(i) 
evaluating by means of the pharmacovigilance
system all information, considering options for risk minimisation and
prevention and taking appropriate measures if necessary;

(j) 
monitoring the pharmacovigilance system and
ensuring that if needed, an appropriate corrective action plan is prepared and
implemented;

(k) 
ensuring that all personnel involved in the performance
of pharmacovigilance activities receives continued training;

(l) 
communicating any regulatory measure that is
taken in a third country and is based on pharmacovigilance data to the
competent authorities and the Agency within 15 days of receipt of such
information.

Article 79
Pharmacovigilance responsibilities of the competent authorities and the Agency

1.           Competent authorities
shall evaluate all adverse events reported to them by healthcare professionals
and animal holders, manage risks and take the measures referred to in Articles 130
to 135 concerning marketing authorisations where necessary.

2.           Competent authorities
shall take all appropriate measures to encourage the reporting of adverse
events by healthcare professionals and animal holders.

3.           Competent authorities may
impose specific requirements on veterinarians and other healthcare
professionals in respect of the reporting of adverse events. The Agency and the
competent authorities may organise meetings or a network for groups of
veterinarians or other healthcare professionals, where there is a specific need
for collecting, collating or analysing specific pharmacovigilance data.

4.           Competent authorities and
the Agency shall provide the general public, veterinarians and other healthcare
professionals with all important information on adverse events relating to the
use of a veterinary medicinal product in a timely manner electronically or
through other publicly available means of communication.

5.           Competent authorities
shall verify by means of inspections referred to in Article 125 that marketing
authorisation holders comply with the requirements relating to
pharmacovigilance laid down in this Section.

6.           The Agency shall evaluate
the adverse events to the centrally authorised veterinary medicinal products,
manage risks and recommend measures to the Commission. The Commission shall
take the measures referred to in Articles 130 to 135 concerning marketing
authorisations where necessary.

Article 80
Delegation of tasks by competent authority

1.           A competent authority may
delegate any of the tasks entrusted to it as referred to in Article 79 to a
competent authority in another Member State subject to the written agreement of
the latter.

2.           The delegating competent
authority shall inform the Commission, the Agency and other Member States of the delegation in writing. The delegating competent authority and the Agency
shall make that information public.

Article 81
Signal management process

1.           Competent authorities and
the Agency shall cooperate in monitoring the data in the pharmacovigilance
database to determine whether there is any change to the benefit-risk balance
of veterinary medicinal products with a view to detecting risks to animal
health, public health and protection of the environment (‘signal management
process’).

2.           Competent authorities and
the Agency shall establish groups of veterinary medicinal products for which
signal management process can be combined with a view of detecting risks to
animal health, public health and protection of the environment.

3.           The Agency and the
coordination group shall agree on sharing of the monitoring of data on groups
of veterinary medicinal products recorded in the pharmacovigilance database.
For each group of veterinary medicinal products a competent authority or the
Agency shall be appointed as responsible for the monitoring thereof (‘lead
authority’).

4.           The results of the signal
management process shall be agreed upon by the competent authorities and, where
appropriate, the Agency. The lead authority shall record the results in the
pharmacovigilance database.

5.           Where necessary, based on
the results of the signal management process referred to in paragraph 4 the
competent authorities or the Commission shall take appropriate measures as referred
to in Articles 130 to 135.

Section 7
Re-examination of a marketing authorisation for a limited market and in
exceptional circumstances

Article 82
Procedure for re-examination of a marketing authorisation for a limited market

1.           Before the expiry of the
period of validity of 3 years, marketing authorisations for a limited market
granted in accordance with Article 21 shall be re-examined on application from
the marketing authorisation holder. After the initial re-examination, it shall
be re-examined every 5 years.

2.           The application for a
re-examination shall be submitted to the competent authority that granted the
authorisation or to the Agency at least 6 months before the expiry of the
limited market marketing authorisation and shall demonstrate that the
veterinary medicinal product remains for use in a limited market and that the
marketing authorisation holder complies, if applicable, with the conditions
referred to in Article 21(1).

3.           When an application for
re-examination has been submitted, the limited market marketing authorisation
shall remain valid until a decision on the application has been adopted by the
competent authority or the Commission.

4.           The competent authority or
the Agency shall assess the application for a re-examination in order to
ascertain whether the benefit-risk balance is positive.

5.           The competent authority or
the Commission may at any time grant a marketing authorisation valid for an
unlimited period of time in respect of a veterinary medicinal product
authorised for a limited market, provided that the holder of the marketing
authorisation for a limited market submits the missing comprehensive quality
and efficacy data referred to in Article 21(1).

Article 83
Procedure for re-examination of a marketing authorisation in exceptional
circumstances

1.           Before the expiry of the
period of validity of 1 year, marketing authorisations granted in accordance
with Article 22 shall be re-examined on application from the marketing
authorisation holder.

2.           The application for
re-examination shall be submitted to the competent authority that granted the
authorisation or the Agency at least 3 months before the expiry of the
marketing authorisation.

3.           When an application for
re-examination has been submitted, the marketing authorisation shall remain
valid until a decision on the application has been adopted by the competent
authority or the Commission.

4.           The competent authority or
the Commission may at any time grant a marketing authorisation valid for an
unlimited period of time, provided that the marketing authorisation holder
submits the missing comprehensive safety and efficacy data referred to in
Article 22(1).

Section 8
Union interest referral

Article 84
Scope of the Union interest referral

1.           Where the interests of the
Union are involved, and in particular the interests of public or animal health
or of the environment related to the quality, safety or efficacy of veterinary
medicinal products or the free movement of products within the Union, any
Member State or the Commission may refer its concern to the Agency for the
application of the procedure laid down in Article 85. The matter of concern
shall be clearly identified.

2.           Upon request from the
Agency, Member States and marketing authorisation holders shall forward to the
Agency all available information relating to the Union interest referral.

3.           Where the referral
provided for in paragraph 1 concerns more than one veterinary medicinal product
or a therapeutic class, the Agency may limit the procedure to specific parts of
the terms of the marketing authorisation.

Article 85
Referral procedure

1.           The Agency shall publish information
about referrals made in accordance with Article 84 on its website. Interested
parties shall be invited to provide comments.

2.           The Committee shall
consider the referred matter and shall issue a reasoned opinion within 90 days
of the date on which the matter was referred to it. That period may be extended
by the Committee for a further period of up to 60 days, taking into account the
views of the marketing authorisation holders concerned.

3.           Before issuing its
opinion, the Committee shall provide the marketing authorisation holder with
the opportunity to present explanations within a specified time limit. The
Committee may suspend the time limit referred to in paragraph 2 to allow the
marketing authorisation holder to prepare the explanations.

4.           In order to consider the
matter, the Committee shall appoint one of its members to act as a rapporteur.
The Committee may appoint independent experts to give advice on specific questions.
When appointing such experts, the Committee shall define their tasks and
specify the time limit for the completion of these tasks.

5.           If it considers it
appropriate, the Committee may invite any other person to provide information
relating to the matter before it.

6.           Within 15 days after its
adoption, the Agency shall forward the final opinion of the Committee to Member
States, the Commission and the marketing authorisation holder, together with an
assessment report of the veterinary medicinal product and the reasons for its
conclusions.

Article 86
Decision following the Union interest referral

1.           Within 15 days after
receipt of the opinion referred to in Article 85(6), the Commission shall
prepare a draft decision. If the draft decision is not in accordance with the
opinion of the Agency, the Commission shall also set out a detailed explanation
of the reasons for the differences in an annex to the draft decision.

2.           The draft decision shall
be forwarded to Member States.

Article 87
Commission decision following the referral

1.           The Commission shall, by
means of implementing acts, take a final decision on the Union interest
referral. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 145(2). Unless otherwise stated in
the referral notification in accordance with Article 84, the decision shall
apply to all veterinary medicinal products subject to the marketing
authorisation that contain the active substance concerned by the referral.

2.           Where the veterinary
medicinal product has been authorised in accordance with the national, mutual
recognition or decentralised procedures, the decision referred to in paragraph
1 shall be addressed to all Member States and communicated to the marketing
authorisation holder for information.

3.           Member States shall take
any necessary action with regard to the marketing authorisations for all
veterinary medicinal products concerned to comply with the decision within 30
days of its notification, unless a different period is foreseen in the decision.

4.           In case of centrally
authorised veterinary medicinal products a decision as referred to in paragraph
1 shall be addressed to the marketing authorisation holder.

Chapter V
Homeopathic veterinary medicinal products

Article 88
Homeopathic veterinary medicinal products

1.           By way of derogation from
Article 5, homeopathic veterinary medicinal products that satisfy the requirements
set out in Article 89 and are not immunological homeopathic veterinary
medicinal products shall be registered in accordance with Article 90.

2.           The competent authorities
shall record homeopathic veterinary medicinal products registered by them in
the database referred to in Article 51.

Article 89
Registration of homeopathic veterinary medicinal products

1.           Homeopathic veterinary
medicinal products that satisfy all of the following conditions shall be
subject to a registration procedure:

(a) 
the medicinal product is administered by a route
described in the European Pharmacopoeia or, in the absence thereof, by the
pharmacopoeias currently used officially in Member States;

(b) 
there is a sufficient degree of dilution to
guarantee the safety of the medicinal product; in particular, the medicinal
product shall not contain more than one part per 10 000 of the mother tincture;

(c) 
no specific therapeutic indication appears on
the labelling of the medicinal product or in any information relating thereto.

2.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 146 in order to
adapt paragraph 1(b) and (c) in the light of new scientific evidence.

Article 90
Requirements and procedure for registration of homeopathic veterinary medicinal
products

1.           The following documents
shall be included in the application for a registration of a homeopathic
veterinary medicinal product:

(a) 
scientific name or other name given in a
pharmacopoeia of the homeopathic stock or stocks, together with a statement of
the various routes of administration, pharmaceutical forms and degree of
dilution to be registered;

(b) 
a dossier describing how the homeopathic stock
or stocks is/are obtained and controlled, and justifying its/their homeopathic
nature, on the basis of an adequate bibliography; in the case of homeopathic
veterinary medicinal products containing biological substances, a description
of the measures taken to ensure the absence of pathogens;

(c) 
the manufacturing and control file for each
pharmaceutical form and a description of the method of dilution and
potentisation;

(d) 
the manufacturing authorisation for the veterinary
medicinal products concerned;

(e) 
copies of any registrations or authorisations
obtained for the same veterinary medicinal products in other Member States;

(f) 
the text to appear on the outer packaging and
immediate packaging of the veterinary medicinal products to be registered;

(g) 
data concerning the stability of the medicinal
product;

(h) 
in the case of veterinary medicinal products
intended for food-producing species, proposed withdrawal period together with
all requisite justification;

(i) 
in the case of veterinary medicinal products
intended for food-producing species and containing pharmacologically active
substances that have not been included in Regulation (EU) No 37/2010 for the
animal species in question, a document certifying that a valid application for
the establishment of maximum residue limits has been submitted to the Agency in
accordance with Regulation (EC) No 470/2009.

2.           An application for
registration may cover a series of medicinal products derived from the same
homeopathic stock or stocks.

3.           In a decision concerning
registration the competent authority shall determine the conditions under which
the homeopathic veterinary medicinal product may be made available to end users
in accordance with Article 29.

4.           The procedure of
registering a homeopathic veterinary medicinal product shall be completed
within 210 days after the submission of a valid application.

Chapter VI
Manufacturing, import and export

Article 91
Manufacturing authorisations

1.           A manufacturing
authorisation shall be required in order to carry out any of the following
activities (‘manufacturing’):

(a) 
to produce or import veterinary medicinal
products; or

(b) 
to engage in any part of the process of
producing a veterinary medicinal product or of bringing a veterinary medicinal
product to its final state, including engaging in the processing, assembling,
packaging, labelling, storage, sterilising, testing or releasing it or any
constituent of it for supply as part of that process.

2.           Notwithstanding paragraph
1, a manufacturing authorisation shall not be required for preparation,
dividing up, changes in packaging or presentation where these processes are
carried out solely for retail in accordance with Articles 107 and 108.

3.           The competent authorities
shall record the manufacturing authorisations granted by them in the database
on manufacturing, import and wholesale distribution set up in accordance with
Article 94.

4.           Manufacturing
authorisations shall be valid throughout the Union.

Article 92
Requirements for obtaining a manufacturing authorisation

1.           Applications for
manufacturing authorisations shall be submitted to a competent authority in the
  Member State where the manufacturing site is located.

2.           An application for a
manufacturing authorisation shall contain at least the following information:

(a) 
veterinary medicinal products which are to be
manufactured or imported;

(b) 
pharmaceutical forms which are to be
manufactured or imported;

(c) 
details about the manufacturing site where the
veterinary medicinal products are to be manufactured or tested;

(d) 
statement to the effect that the applicant
fulfils the requirements laid down in Article 98.

Article 93
Granting of manufacturing authorisations

1.           Before granting a
manufacturing authorisation, the competent authority shall carry out an
inspection in accordance with Article 125 of the manufacturing site where the
veterinary medicinal products are to be manufactured or tested.

2.           An authorisation shall
apply only to the manufacturing site, the veterinary medicinal products, and
the pharmaceutical forms specified in the application.

3.           Member States shall lay
down procedures for granting manufacturing authorisations. The procedures for
granting a manufacturing authorisation shall not exceed 90 days from the day on
which the competent authority receives the application.

4.           The competent authority
may require the applicant to submit further information in addition to that
supplied in the application pursuant to Article 92. Where the competent
authority exercises this right, the time limit referred to in paragraph 3 of
this Article shall be suspended until the additional data required has been
submitted.

5.           A manufacturing
authorisation may be granted conditionally, subject to a requirement for the
applicant to undertake actions or introduce specific procedures within a given
time period. The manufacturing authorisation may be suspended if these
requirements are not complied with.

Article 94
Database on manufacturing authorisations

1.           A Union database on
manufacturing, import and wholesale distribution shall be set up and maintained
by the Agency ('manufacturing and wholesale distribution database').

2.           The database shall include
information on any manufacturing and wholesale distribution authorisations
granted by competent authorities within the Union.

3.           The Agency shall make
public a format for electronic submissions of data to the database.

4.           Competent authorities
shall record in the manufacturing and wholesale distribution database information
on authorisations and certificates granted in accordance with Articles 93, 103
and 105 together with information on the veterinary medicinal products covered
by the authorisations, using the format referred to in paragraph 3.

5.           The Agency shall, in
collaboration with Member States and the Commission, draw up functional specifications
for the manufacturing and wholesale distribution database.

6.           The Agency shall ensure
that information reported to the database is collated and made accessible and
that the information is shared.

Article 95
Access to the database on manufacturing authorisations

1.           The competent authorities
shall have full access to the database set up in accordance with Article 94.

2.           Manufacturers and
wholesalers shall have access to the database to the extent necessary for them
to comply with their obligations.

3.           The general public shall
have access to information in the database specifying the companies that have
been granted manufacturing or wholesale distribution authorisations and the
manufacturing sites and products concerned by these authorisations.

Article 96
Changes to manufacturing authorisations on request

1.           If the holder of a
manufacturing authorisation requests a change in that manufacturing
authorisation, the procedure for examining such a request shall not exceed 30
days from the day on which the competent authority receives the request. In
exceptional cases, this period of time may be extended by the competent
authority to 90 days.

2.           The application shall
contain description of the requested change and the authorised products
affected by this change.

3.           Within the period referred
to in paragraph 1, the competent authority may request the holder to provide
supplementary information within a set time limit. The procedure shall be
suspended until such time as the supplementary information has been provided.

4.           The competent authority
shall inform the holder of the outcome of the assessment and where appropriate,
amend the manufacturing authorisation, and update, where appropriate, the manufacturing
and wholesale distribution database.

Article 97
Manufacturing authorisation for import and export

1.           The manufacturing
authorisation shall also be required for imports from and exports to third
countries.

2.           The requirement referred
to in paragraph 1 shall not apply to holders of a wholesale distribution
authorisation referred to in Article 104.

Article 98
Obligations of the manufacturing authorisation holders

The holder of a manufacturing authorisation
shall:

(a) 
have at his disposal suitable and sufficient
premises, technical equipment and testing facilities for the manufacture,
export or import of the veterinary medicinal products stated in the manufacturing
authorisation;

(b) 
have at his disposal the services of at least
one qualified person within the meaning of Article 100;

(c) 
enable the qualified person referred to in
Article 100 to carry out his duties, particularly by placing at his disposal
all the necessary technical equipment and testing facilities;

(d) 
inform the competent authority if the qualified
person referred to in Article 100 is replaced;

(e) 
have at his disposal the services of staff
complying with the legal requirements existing in the Member State concerned as regards both manufacture and controls;

(f) 
allow the representatives of the competent
authority access to his premises at any time;

(g) 
keep detailed records of all veterinary
medicinal products supplied by him, including samples, in accordance with
Article 99.

Article 99
Record keeping

1.           The following information
shall be recorded in respect of all veterinary medicinal products supplied by
the holder of a manufacturing authorisation:

(a) 
date of the transaction,

(b) 
name of the veterinary medicinal product,

(c) 
quantity supplied,

(d) 
name and address of the recipient,

(e) 
batch number.

2.           The records mentioned in
paragraph 1 shall be available for inspection by competent authorities for a
period of 3 years.

Article 100
Qualified person for manufacturing

1.           The holder of a
manufacturing authorisation shall have permanently and continuously at his
disposal the services of at least one qualified person who fulfils the conditions
laid down in this Article and is responsible, in particular, for carrying out
the duties specified in Article 101.

2.           The qualified person shall
be in possession of a diploma, certificate or other evidence of appropriate
qualification and shall have acquired sufficient experience in the field of
manufacturing. The holder of the authorisation may himself assume the
responsibility referred to in paragraph 1, if he personally fulfils those
conditions as specified above.

Article 101
Batch release of veterinary medicinal products

1.           Where veterinary medicinal
products have been manufactured by the holder of a manufacturing authorisation,
the qualified person for manufacturing shall ensure that each batch of the
veterinary medicinal products has been manufactured and tested in compliance
with the terms of the marketing authorisation. The qualified person for
manufacturing shall prepare a report to this effect.

2.           Where veterinary medicinal
products have been imported from third countries, the qualified person for
manufacturing shall ensure that each imported production batch has undergone in
the Union a qualitative and a quantitative analysis of at least all the active
substances, and all the other tests necessary to ensure the quality of the
veterinary medicinal products in accordance with the requirements of the
marketing authorisation.

3.           The reports signed by the
qualified person as referred to in paragraph 1 shall be valid throughout the Union.

4.           The qualified person for
manufacturing shall keep records in respect of each released production batch.
These records shall be kept up to date as operations are carried out and shall
remain at the disposal of the competent authority for a period of 5 years.

5.           Where veterinary medicinal
products manufactured in the Union are imported into the Union from a third
country, paragraph 1 shall apply.

6.           Where veterinary medicinal
products are imported from third countries with which the Union has made
arrangements regarding application of standards of good manufacturing practice
at least equivalent to those laid down in Commission Directive 91/412/EEC[27] and it is demonstrated
that the tests referred to in paragraph 1 have been carried out in the
exporting country, the competent authority in the Member State of importation
may relieve the qualified person of the of responsibility for carrying out the
tests referred to in paragraph 2.

Article 102
Competent authorities' measures

1.           The competent authority
shall ensure that the obligations of qualified persons referred to in Article 100
are fulfilled, either by means of appropriate administrative measures or by
making such persons subject to a professional code of conduct.

2.           The competent authority
may temporarily suspend such persons upon the commencement of administrative or
disciplinary proceedings against them for failure to fulfil their obligations.

Article 103
Certificates of manufacturing authorisations

Upon request of the manufacturer or
exporter of veterinary medicinal products, or of the authorities of an
importing third country, the competent authority shall certify that the
manufacturer:

(a) 
holds a manufacturing authorisation for the
product in question, or

(b) 
possesses a certificate of good manufacturing practice
as referred to in Article 127.

When issuing such certificates, the
competent authority shall attach the approved summary of the product
characteristics or, in the absence thereof, an equivalent document, in case of
veterinary medicinal products intended for export which are already authorised
in their territory.

Chapter VII
Supply and use

Section 1 
Wholesale distribution

Article 104
Wholesale distribution of veterinary medicinal products

1.           The wholesale distribution
of veterinary medicinal products shall be subject to the holding of a wholesale
distribution authorisation. Member States shall lay down procedures for
granting a wholesale distribution authorisation.

2.           Wholesale distribution
authorisations shall be valid throughout the Union.

3.           Supplies of small
quantities of veterinary medicinal products from one retailer to another shall
not be regarded as wholesale distribution.

4.           The wholesale distributor
shall have an emergency plan guaranteeing the effective implementation of any
withdrawal ordered by the competent authorities or the Commission or undertaken
in cooperation with the manufacturer of the veterinary medicinal product in
question or marketing authorisation holder.

5.           A wholesale distributor
shall supply veterinary medicinal products only to persons permitted to carry
out retail activities in the Member State in accordance with Article 107(1),
other wholesale distributors and exporters of veterinary medicinal products.

Article 105
Procedure for granting wholesale distribution authorisations

1.           An application for a
wholesale distribution authorisation shall be submitted to the competent
authority of the Member State in which the wholesale distributor is established.

2.           The procedure for granting
a wholesale distribution authorisation shall not exceed 90 days from the date
on which the competent authority receives an application.

3.           An applicant shall
demonstrate in the application that he fulfils the following requirements:

(a) 
has at his disposal technically competent staff
and suitable and sufficient premises complying with the requirements laid down
by the Member State concerned as regards the storage and handling of veterinary
medicinal products;

(b) 
has an emergency plan guaranteeing effective
implementation of any withdrawal ordered by the competent authorities or the
Commission or undertaken in cooperation with the manufacturer of the veterinary
medicinal product in question or marketing authorisation holder;

(c) 
has an appropriate record keeping system
ensuring compliance with the requirements referred to in Article 106.

4.           The competent authority
shall inform the applicant of the outcome of the evaluation, grant or refuse
the wholesale distribution authorisation, and upload the relevant information
of the authorisation in the manufacturing and wholesale distribution database.

Article 106
Record keeping requirements for wholesale distributors

1.           The wholesale distributor
shall keep detailed records. The following minimum information shall be
recorded in respect of each purchase and sale transaction:

(a) 
date of the transaction;

(b) 
name of the veterinary medicinal product;

(c) 
batch number,

(d) 
expiry date of the veterinary medicinal product;

(e) 
quantity received or supplied;

(f) 
name and address of the supplier in the event of
purchase or of the recipient in the event of sale.

2.           At least once a year the
holder of a wholesale distribution authorisation shall carry out a detailed
audit of the stock and compare the incoming and outgoing medicinal products
with products currently held in stock. Any discrepancies found shall be
recorded. The records shall be available for inspection by the competent
authorities for a period of three years.

Section 2 
Retail

Article 107
Retail of veterinary medicinal products and record keeping

1.           The retail of veterinary
medicinal products shall be conducted only by persons who are permitted to
carry out such operations under national law.

2.           Persons qualified to
prescribe veterinary medicinal products in accordance with applicable national
law shall retail antimicrobial products only for animals which are under their
care, and only in the amount required for the treatment concerned.

3.           Retailers of veterinary
medicinal products shall keep detailed records of the following information in
respect of each purchase and sale of veterinary medicinal products:

(a) 
date of the transaction;

(b) 
name of the veterinary medicinal product;

(c) 
batch number;

(d) 
quantity received or supplied;

(e) 
name and address of the supplier in the event of
purchase, or of  the recipient in the event of sale;

(f) 
name and address of the prescribing veterinarian
and a copy of the prescription in case of veterinary medicinal products
requiring a prescription in accordance with Article 29.

4.           At least once a year a
retailer shall carry out a detailed audit of the stock and compare the incoming
and outgoing veterinary medicinal products recorded with products currently
held in stock. Any discrepancies found shall be recorded. The records shall be
available for inspection by the competent authorities in accordance with
Article 125 for a period of three years.

Article 108
Retail of veterinary medicinal products at a distance

1.           Persons permitted to
supply veterinary medicinal products in accordance with Article 107(1) may
offer veterinary medicinal products by means of information society services in
the meaning of Directive 98/34/EC of the European Parliament and of the Council[28] to natural or legal
persons established in the Union under the condition that those medicinal
products comply with the legislation of the destination Member State.

2.           In addition to the
information requirements set out in Article 6 of the Directive 2000/31/EC of
the European Parliament and of the Council[29],
websites offering veterinary medicinal products shall contain at least:

(a) 
the contact details of the competent authority
of the Member State in which the retailer offering the veterinary medicinal
products is established;

(b) 
a hyperlink to the website of the Member State of establishment set up in accordance with paragraph 5;

(c) 
the common logo established in accordance with
paragraph 3 clearly displayed on every page of the website that relates to the
offer for sale at a distance to the public of veterinary medicinal products and
containing a hyperlink to the entry of the retailer in the list of authorised
retailers referred to in point (c) of paragraph 5.

3.           A common logo shall be
established that is recognisable throughout the Union, while enabling the
identification of the Member State where the person offering veterinary
medicinal products for sale at a distance to the public is established. The
logo shall be clearly displayed on websites offering veterinary medicinal
products for sale at a distance.

4.           The Commission shall adopt
the design of the common logo by means of implementing acts. Those implementing
acts shall be adopted in accordance with the examination procedure referred to
in Article 145(2).

5.           Each Member State shall
set up a website regarding sale of veterinary medicinal products at a distance,
providing at least the following information:

(a) 
information on its national legislation
applicable to the offering of veterinary medicinal products for sale at a
distance to the public by means of information society services, including
information on the fact that there may be differences between Member States
regarding the classification of the supply of the veterinary medicinal
products;

(b) 
information on the common logo;

(c) 
a list of retailers established in the Member State authorised to offer veterinary medicinal products for sale at a distance to
the public by means of information society services in accordance with
paragraph 1 as well as the website addresses of those retailers.

The websites set up by Member States shall
contain a hyperlink to the website of the Agency set up in accordance with
paragraph 6.

6.           The Agency shall set up a
website providing information on the common logo. The Agency’s website shall
explicitly mention that the websites of Member States contain information on
persons authorised to offer veterinary medicinal products for sale at a
distance to the public by means of information society services in the Member State concerned.

7.           Members States may impose
conditions, justified on grounds of public health protection, for the retail on
their territory of medicinal products offered for sale at a distance to the
public by means of information society services.

Article 109
Retail of anabolic, anti-infectious, anti-parasitic, anti-inflammatory,
hormonal or psychotropic veterinary medicinal products

1.           Only manufacturers,
wholesale distributors and retailers authorised specifically to do so in
accordance with applicable national law shall be allowed to supply and purchase
veterinary medicinal products which have anabolic, anti-infectious,
anti-parasitic, anti-inflammatory, hormonal or psychotropic properties or
substances which may be used as veterinary medicinal products having those
properties.

2.           The competent authorities
shall maintain a register of manufacturers, wholesale distributors and
retailers authorised in accordance with paragraph 1.

3.           Those manufacturers and
suppliers shall keep detailed records of the following information in respect
of each purchase and sale transaction:

(a) 
date of transaction;

(b) 
name and marketing authorisation number of the
veterinary medicinal product;

(c) 
quantity received or supplied;

(d) 
name and address of the supplier in the event of
purchase, or of  the recipient in the event of sale.

These records shall be available for
inspection by the competent authorities in accordance with Article 125 for a
period of 3 years.

Article 110
Veterinary prescriptions

1.           A veterinary prescription
shall contain at least the following elements (‘minimum requirements’):

(a) 
identification of the animal under treatment;

(b) 
full name and contact details of the animal
owner or keeper;

(c) 
issue date;

(d) 
full name and contact details, qualifications
and professional membership number of the person writing the prescription;

(e) 
signature or an equivalent electronic form of
identification of the person writing the prescription;

(f) 
name of the prescribed product;

(g) 
pharmaceutical form (tablet, solution, etc.);

(h) 
quantity;

(i) 
strength;

(j) 
dosage regimen;

(k) 
withdrawal period if relevant;

(l) 
any necessary warnings;

(m) 
if a product is prescribed for a condition not
mentioned in the marketing authorisation for that product, a statement to that
effect.

2.           A veterinary prescription
shall only be issued by a person qualified to do so in accordance with
applicable national law.

3.           Where a veterinary
medicinal product is supplied on prescription, the quantity prescribed and
supplied shall be restricted to the amount required for the treatment or
therapy concerned.

4.           Veterinary prescriptions
shall be recognised throughout the Union. A veterinary medicinal product
prescribed shall be supplied in accordance with applicable national law.

Section 3 
Use

Article 111
Use of veterinary medicinal products

1.           Veterinary medicinal
products shall be used in accordance with the terms of the marketing
authorisation.

2.           Member States shall lay
down procedures for placing on the market of the medicinal products allowed to
be used in their territory in accordance with Articles 115, 116, 119, 120 and
121.

Article 112
Record keeping by owners and keepers of food-producing animals

1.           Owners or, where the
animals are not kept by the owners, keepers of food-producing animals shall
keep records of the veterinary medicinal products they use and, if applicable,
a copy of the veterinary prescription.

2.           The following information
shall be recorded:

(a) 
date of administering the veterinary medicinal
product to the animal;

(b) 
name of the veterinary medicinal product;

(c) 
quantity of the veterinary medicinal product
administered;

(d) 
name and address of the supplier;

(e) 
identification of the animals treated;

(f) 
name and address of the prescribing veterinarian
and, if applicable, a copy of the prescription.

3.           The information contained
in these records shall be available for inspections by the competent
authorities in accordance with Article 125 for a period of at least 3 years.

Article 113
Use of immunologicals

1.           The competent authorities
may, in accordance with their national legislation, prohibit the manufacture,
import, sale, supply and/or use of immunological veterinary medicinal products
on the whole of their territory or in a part of it if at least one of the
following conditions is fulfilled:

(a) 
the administration of the product to animals may
interfere with the implementation of a national programme for the diagnosis,
control or eradication of animal disease;

(b) 
the administration of the product to animals may
cause difficulties in certifying the absence of contamination in live animals
or in foodstuffs or other products obtained from treated animals;

(c) 
the disease to which the product is intended to
confer immunity is largely absent from the territory concerned.

2.           The competent authorities
shall inform the Commission of all instances in which the provisions of
paragraph 1 are applied.

Article 114
Veterinarians providing services in other Member States

1.           A veterinarian providing
services in a Member State other than the one where he is established (the ‘host
Member State’) may administer veterinary medicinal products authorised in the host
Member State to animals in another Member State which are under his care in the
amount required for the treatment of those animals where the following
conditions are fulfilled:

(a) 
the authorisation to place the veterinary
medicinal product on the market provided for in Article 5 has been issued by
the competent authorities of the host Member State or by the Commission;

(b) 
the veterinary medicinal products are
transported by the veterinarian in the original packaging;

(c) 
where intended for administration to
food-producing animals, the veterinary medicinal products have the same
qualitative and quantitative composition of active substances as the veterinary
medicinal products authorised in the host Member State;

(d) 
the veterinarian follows the good veterinary
practices applied in that Member State and ensures that the withdrawal period
specified on the labelling of the veterinary medicinal product is observed;

(e) 
the veterinarian does not retail any veterinary
medicinal product to an owner or keeper of animals treated in the host Member
State unless this is permissible under the rules of the host Member State, the
medicinal product is intended for animals under his care, and only the minimum
quantities of veterinary medicinal product necessary to complete the treatment
of those animals are retailed;

(f) 
the veterinarian keeps detailed records of the
animals treated, their diagnosis, the veterinary medicinal products
administered, the dose administered, the duration of treatment and the
withdrawal period applied, for inspection by the competent authorities of the
host Member State for a period of 3 years.

2.           Paragraph 1 shall not
apply to immunological veterinary medicinal products which are not authorised for
use in the host Member State.

Article 115
Use of medicinal products for species or indications outside the terms of the
marketing authorisation in non food-producing species

1.           By way of derogation from
Article 111, where there is no authorised veterinary medicinal product in a
Member State for a condition affecting a non-food producing animal, the
veterinarian responsible may, under his/her direct personal responsibility and
in particular to avoid causing unacceptable suffering, exceptionally treat the
animal concerned with the following:

(a) 
a medicinal product:

(i) a veterinary medicinal product
authorised under this Regulation in the Member State concerned for use with
another animal species, or for another condition in the same species;

(ii) a veterinary medicinal product
authorised under this Regulation in another Member State for use in the same
species or in another species, for the same condition or for another condition;

(iii) a medicinal product for human use authorised
in the Member State concerned in accordance with Directive 2001/83/EC of the
European Parliament and of the Council[30]
or Regulation (EC) No 726/2004;

(b) 
if there is no product as referred to in point (a),
a veterinary medicinal product prepared extemporaneously in accordance with the
terms of a veterinary prescription by a person authorised to do so under
national legislation.

2.           The veterinarian may
administer the medicinal product personally or allow another person to do so
under the veterinarian's responsibility.

3.           Paragraph 1 of this
Article shall also apply to the treatment by a veterinarian of an animal
belonging to the equidae family provided that it has been declared, in
accordance with Regulation (EC) No 504/2008, as not being intended for
slaughter for human consumption.

Article 116
Use of medicinal products for species or indications outside the terms of the
marketing authorisation in food-producing species

1.           By way of derogation from
Article 111, where there is no authorised veterinary medicinal product in a
Member State for a condition affecting a food-producing animal of a non-aquatic
species, the veterinarian responsible may, under his direct personal
responsibility and in particular to avoid causing unacceptable suffering,
exceptionally treat the animal concerned with any of the following:

(a) 
a veterinary medicinal product authorised under
this Regulation in the Member State concerned for use with another
food-producing animal species, or for another condition in the same species;

(b) 
a veterinary medicinal product authorised under
this Regulation in another Member State for use in the same species or in
another food-producing species for the same condition or for another condition;

(c) 
a medicinal product for human use authorised in
the Member State concerned in accordance with Directive 2001/83/EC or under
Regulation (EC) No 726/2004, or

(d) 
if there is no product as referred to in point
(a), a veterinary medicinal product prepared extemporaneously in accordance
with the terms of a veterinary prescription by a person authorised to do so
under national legislation.

2.           By way of derogation from
Article 111, where there is no authorised veterinary medicinal product in a
Member State for a condition affecting a food-producing aquatic species, the
veterinarian responsible may, under his direct personal responsibility and in
particular to avoid causing unacceptable suffering, treat the animals concerned
with any of the following medicinal products:

(a) 
veterinary medicinal products authorised under
this Regulation in the Member State concerned for use with another
food-producing aquatic species, or for another condition in the same aquatic
species;

(b) 
veterinary medicinal products authorised under
this Regulation in another Member State for use in the same aquatic species or
in another food-producing aquatic species for the condition in question or for
another condition.

3.           By way of derogation from
paragraph 2, and until an implementing act referred to in paragraph 4 is
established, if there is no product as referred to in subparagraphs (a) and (b)
of paragraph 2, a veterinarian may, under his direct personal responsibility
and in particular to avoid causing unacceptable suffering, exceptionally treat
food-producing animals of an aquatic species on a particular holding with:

(a) 
a veterinary medicinal product authorised under
this Regulation in the Member State concerned or in another Member State for use with a food-producing non-aquatic species;

(b) 
a medicinal product for human use authorised in
the Member State concerned in accordance with Directive 2001/83/EC or under
Regulation (EC) No 726/2004.

4.           The Commission may, by
means of implementing acts, establish a list of veterinary medicinal products
authorised in the Union for use in terrestrial animals which can be used for
treatment of food-producing animals of an aquatic species in accordance with
paragraph 1. Those implementing acts shall be adopted in accordance with the
examination procedure referred to in Article 145(2).

The Commission shall take account of the
following criteria when adopting those implementing acts:

(a) 
 risks to the environment if aquatic animals are
treated with these medicinal products;

(b) 
impact on animal health and public health if the
aquatic animal affected by the condition cannot receive treatment with the
potential listed antimicrobial medicinal product;

(c) 
impact on the competitiveness of certain sectors
in aquaculture in the Union if the animal affected by the condition cannot
receive treatment with the antimicrobial medicinal product concerned;

(d) 
availability or lack of availability of other
medicines, treatments or measures for prevention or treatment of diseases or
certain conditions in aquatic animals.

5.           For the purpose of
treatment in accordance with paragraphs 1 to 3, the veterinarian may administer
the medicinal product personally or allow another person to do so under the
veterinarian's responsibility.

6.           Pharmacologically active
substances included in the medicinal product used in accordance with paragraph
1 shall be listed in Table 1 of the Annex to Regulation (EU) No 37/2010. The
veterinarian shall specify an appropriate withdrawal period in accordance with
Article 117.

7.           By way of derogation from
paragraph 1 and from Article 16(1) of Regulation (EC) No 470/2009 and in case
there is no medicinal product available as referred to in paragraph 1, a
veterinarian may treat bees, during the period when no honey or other
foodstuffs is produced, with a veterinary medicinal product authorised for bees
in a third country which is a member or an observer of the International Cooperation
on Harmonisation of Technical Requirements for Registration of Veterinary
Medicinal Products.

8.           The veterinarian shall
keep records of the date of examination of the animals, details of the owner,
the number of animals treated, the diagnosis, the medicinal products
prescribed, the doses administered, the duration of the treatment and the
withdrawal periods recommended, and shall make those records available for
inspection by the competent authorities for a period of at least 5 years.

Article 117
Withdrawal period for products used outside the terms of the marketing
authorisation in food-producing species

1.           For the purpose of Article
116, unless a product used has a withdrawal period provided in its summary of
the product characteristics for the species in question, a withdrawal period
shall be set by the veterinarian  in accordance with the following criteria:

(a) 
for meat and offal of food producing mammals and
birds not less than:

(i) the longest withdrawal period provided
in its summary of the product characteristics for any animal species multiplied
by factor 1,5;

(ii) if the product is not authorised for
food producing species, 28 days;

(b) 
for animal species producing milk for human
consumption not less than:

(i) the longest withdrawal period provided
in the summary of the product characteristics for any milk producing species
multiplied by factor 1.5;

(ii) if the product is not authorised for
any milk producing species, 7 days;

(c) 
for animal species producing eggs for human
consumption not less than:

(i) the longest withdrawal period provided
in the summary of the product characteristics for eggs multiplied by factor
1.5;

(ii) if the product is not authorised for
any eggs producing species, 7 days;

(d) 
for aquatic animal species for human consumption
and aquatic animal species producing eggs for human consumption not less than:

(i) the longest withdrawal period for any
of the aquatic species indicated in the summary of the product characteristics
multiplied by factor of 50 and expressed as number of days multiplied by the average
water temperature (‘degree-days’). The withdrawal period shall not be less than
50 degree-days;

(ii) if the product is not authorised for
food producing aquatic animal species, 500 degree-days.

2.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 146 in order to
amend the rules laid down in paragraph 1 in the light of new scientific
evidence.

3.           For bees, the veterinarian
shall determine the appropriate withdrawal period by assessing the specific situation
of the particular beehive(s) on a case-by-case basis.

4.           With regard to homeopathic
veterinary medicinal products the withdrawal period shall be established at
zero days.

5.           By way of derogation from
paragraph 1, the Commission shall establish a list of substances:

(a) 
which are essential for the treatment of
equidae, or which bring added clinical benefit compared to other treatment
options available for equidae;

(b) 
for which the withdrawal period for equidae
shall not be less than six months subject to the control mechanisms laid down
in Decisions 93/623/EEC and 2000/68/EC.

Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 145(2).

Article 118
Use of antimicrobial veterinary medicinal products for species or indications
outside the terms of the marketing authorisation

1.           Antimicrobial medicinal
products shall only be used in accordance with Articles 115 and 116 to treat
conditions for which there is no other treatment available, and the use of
which would not present a risk to public or animal health.

2.           The Commission may, by
means of implementing acts in accordance with the examination procedure
referred to in Article 145(2), and taking into consideration scientific advice
of the Agency, establish a list of antimicrobial medicinal products that cannot
be used in accordance with paragraph 1, or which can only be used for treatment
in accordance with paragraph 1 subject to certain conditions.

When adopting those implementing acts, the
Commission shall take account of the following criteria:

(a) 
risks to public health if the antimicrobial
product is used in accordance with paragraph 1;

(b) 
risk for human health in case of development of
antimicrobial resistance;

(c) 
availability of other treatments for animals,

(d) 
availability of other antimicrobial treatments
for humans;

(e) 
impact on aquaculture and farming if the animal
affected by the condition receives no treatment.

Article 119
Health situation and listed diseases

1.           By way of derogation from
Article 111, a competent authority may allow the use in its territory of
veterinary medicinal products not authorised in that Member State, where the
situation of animal or public health so requires, and the marketing of those veterinary
medicinal products is authorised in another Member State.

2.           By way of derogation from
Article 111, in the event of an outbreak of a listed disease as referred to in
Article 5 of Regulation (EC) No.../.... of the European Parliament and the Council[31] [Office of
Publications, please insert number and, in a footnote, date, title and the OJ
reference for the Regulation on animal health] a competent authority may
allow, for a limited period of time and under specific restrictions, the use of
an immunological veterinary medicinal product authorised in another Member
State.

Article 120
Exemption for veterinary medicinal products for certain animals kept
exclusively as pets

Where veterinary medicinal products are intended
solely for aquatic animals, cage birds, homing pigeons, terrarium animals,
small rodents, ferrets and rabbits kept exclusively as pets, Member States may
permit exemptions, in their territory, from Article 5, provided that such
products do not contain substances the use of which requires veterinary controls
and that all possible measures are taken to prevent unauthorised use of the
products for other animals.

Article 121
Use of immunologicals from third countries

If an animal is being imported from, or
exported to, a third country and is thereby subject to specific binding health
rules, a competent authority may permit the use, for the animal in question, of
an immunological veterinary medicinal product that is not covered by a
marketing authorisation in the Member State in question but is authorised under
the legislation of the third country. A competent authority shall supervise the
importation and the use of such immunological products.

Article 122
Disposal of veterinary medicinal products

Member States shall ensure that appropriate
collection systems are in place for veterinary medicinal products that are
unused or expired.

Section 4
Advertising

Article 123
Advertising of veterinary medicinal products

1.           The advertising of a
veterinary medicinal product shall make it clear that it aims at promoting the
prescription, sale or use of the veterinary medicinal product.

2.           The advertising shall be
coherent with the summary of product characteristics and shall not include
information in any form which could be misleading or lead to overconsumption of
the veterinary medicinal product.

Article 124
Prohibition of advertising of certain veterinary medicinal products

1.           The advertising of the
following veterinary medicinal products shall be prohibited :

(a) 
veterinary medicinal products which are
available on veterinary prescription only;

(b) 
veterinary medicinal products which contain
psychotropic drugs or narcotics, including those covered by the United Nations
Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol and
the United Nations Convention on Psychotropic Substances of 1971.

2.           The prohibition laid down
in paragraph 1 shall not apply to advertising to persons permitted to prescribe
or supply veterinary medicinal products.

Chapter VIII
Inspections and controls

Article 125
Controls

1.           Competent authorities shall
perform controls of manufacturers, importers, marketing authorisation holders,
wholesale distributors and suppliers of the veterinary medicinal products
regularly, on a risk-basis, in order to verify that the requirements as set out
in this Regulation are complied with.

2.           The risk-based controls
referred to in paragraph 1 shall be carried out by the competent authorities
taking account of:

(a) 
the risk of non-compliance with the legal
requirements associated with the activities of the undertakings and the
location of the activities,

(b) 
the entity’s past record as regards the results
of inspections performed on them and their compliance with the requirements,

(c) 
any information that might indicate
non-compliance with the legal requirements,

(d) 
the potential impact of non-compliance with the
requirements on public health, animal health and the environment.

3.           Inspections may also be
carried out upon request of another competent authority, the Commission or the
Agency.

4.           The inspections shall be
carried out by authorised representatives of the competent authority who shall
be empowered to:

(a) 
inspect manufacturing or supply establishments
and any laboratories entrusted by the manufacturing authorisation holder with
the task of carrying out control tests;

(b) 
take samples of veterinary medicinal products
and starting materials, including with a view to submit them for an independent
analysis by an Official Medicines Control Laboratory or by a laboratory
designated for that purpose by a Member State;

(c) 
examine any documents relating to the object of
the inspection;

(d) 
inspect the premises, records, documents and
pharmacovigilance systems of marketing authorisation holders or any parties
performing the activities as provided in Chapter IV on behalf of a marketing
authorisation holder.

If necessary, the inspections may be
carried out unannounced.

5.           After each control, a
competent authority shall draft a report on compliance with the requirements
set out in this Regulation. Before adopting a report, the inspected entity
shall have the opportunity to submit comments.

6.           Inspection reports shall
be uploaded to the appropriate database, with continuous access for all
competent authorities.

Article 126
Audits by the Commission

The Commission may carry out audits in
Member States for the purpose of verifying the controls carried out by the
competent authorities. After each audit, the Commission shall draft a report
containing, where appropriate, recommendations to the Member State concerned. The audit report may be made public by the Commission.

Article 127
Certificates of good manufacturing practice

1.           Within 90 days after an
inspection of a manufacturer, a certificate of good manufacturing practice
shall be issued to the manufacturer if the inspection established that the
manufacturer in question is complying with the requirements as set out in this
Regulation and taking due account of the principles and guidelines on good
manufacturing practice.

2.           Competent authorities
shall enter the certificates of good manufacturing practice into the database for
manufacturing authorisations.

3.           The conclusions reached
following an inspection of a manufacturer shall be valid throughout the Union.

4.           The competent authority
may carry out inspections of starting material manufacturers at the
manufacturer's own request. The competent authority shall verify that the
manufacturing processes used in the manufacture of immunological veterinary
medicinal products are validated and batch-to-batch consistency is ensured.

5.           Without prejudice to any
arrangements which may have been concluded between the Union and a third
country, a competent authority, the Commission or the Agency may require a
manufacturer established in a third country to undergo an inspection as
referred to in paragraph 1.

6.           In order to verify whether
the data submitted for obtaining a conformity certificate comply with the
monographs of the European Pharmacopoeia, the standardisation body for
nomenclatures and quality norms within the meaning of the Convention on the
elaboration of a European Pharmacopoeia accepted by Council Decision 94/358/EC[32] (European Directorate
for the Quality of Medicines & Healthcare) may ask the Commission or the
Agency to request an inspection when the starting material concerned is subject
to a European Pharmacopoeia monograph. In the event of an inspection carried
out upon request of the European Pharmacopoeia (European Directorate for the
Quality of Medicines & Healthcare), a certificate of compliance with the
monograph shall be issued.

Article 128
Specific rules on pharmacovigilance inspections

1.           The pharmacovigilance
inspections shall be coordinated by the Agency together with the competent
authorities and shall ensure that all pharmacovigilance system master files in
the Union, as identified in the product database, are regularly checked.

2.           The competent authority in
the Member State in which the qualified person responsible for
pharmacovigilance operates shall carry out pharmacovigilance inspections. Any work-sharing
initiatives and delegation of responsibilities between competent authorities shall
ensure that there is no duplication of inspections of pharmacovigilance system
master files.

3.           The results of the pharmacovigilance
inspections shall be collected in the pharmacovigilance database.

Article 129
Proof of the product quality

1.           The marketing
authorisation holder shall provide proof of the control tests carried out on
the veterinary medicinal product or on the constituents and intermediate
products of the manufacturing process, in accordance with the methods laid down
in marketing authorisation.

2.           For the purposes of
application of paragraph 1, competent authorities may require the marketing
authorisation holder for immunological veterinary medicinal products to submit
to the competent authorities the copies of all the control reports signed by
the qualified person in accordance with Article 101.

3.           The marketing
authorisation holder for immunological veterinary medicinal products shall
ensure that an adequate number of representative samples of each batch of veterinary
medical products is held in stock at least up to the expiry date, and provide
samples promptly to the competent authorities upon request.

4.           Where necessary for
reasons of human or animal health, a competent authority may require the
marketing authorisation holder for an immunological veterinary medicinal
product to submit samples of batches of the bulk product and/or veterinary
medicinal product for control by an Official Medicines Control Laboratory
before the product is made available on the market.

5.           Upon request by the
competent authority, the marketing authorisation holder shall promptly supply
the samples referred to in paragraph 4, together with the reports of the
control referred to in this Chapter. The competent authority shall inform the
competent authorities in other Member States in which the veterinary medicinal
product is authorised as well as the European Directorate for the Quality of
Medicines & HealthCare of its intention to control batches or the batch in
question.

In such cases, the competent authorities of
another Member State shall not apply the provisions of paragraph 4.

6.           On the basis of the
control reports referred to in this Chapter, the laboratory responsible for the
control shall repeat, on the samples provided, all the tests carried out by the
manufacturer on the finished product, in accordance with the relevant
provisions shown in the dossier for marketing authorisation.

7.           The list of tests to be
repeated by the laboratory responsible for the control shall be restricted to
justified tests, provided that all competent authorities in the Member States concerned,
and if appropriate the European Directorate for the Quality of Medicines &
HealthCare, agree to this.

For immunological veterinary medicinal
products authorised under the centralised procedure, the list of tests to be
repeated by the control laboratory may be reduced only upon agreement of the
Agency.

8.           The competent authorities shall
recognise the results of the tests.

9.           Unless the Commission is
informed that a longer period is necessary to conduct the tests, the competent
authorities shall ensure that this control is completed within 60 days of
receipt of the samples.

10.         The competent authority
shall notify the competent authorities of other Member States concerned, the
European Directorate for the Quality of Medicines & HealthCare, the
marketing authorisation holder and, if appropriate, the manufacturer, of the
results of the tests within the same period of time.

11.         If a competent authority
concludes that a batch of a veterinary medicinal product is not in conformity
with the control report of the manufacturer or the specifications provided for
in the marketing authorisation, it shall take measures vis-a-vis the marketing
authorisation holder and the manufacturer, and shall inform accordingly the
competent authorities of other Member States in which the veterinary medicinal
product is authorised.

Chapter IX
Restrictions and penalties

Article 130
Temporary safety restrictions

1.           In the event of a risk to
public or animal health or to the environment that requires urgent action, the
competent authorities or, in the case of centralised marketing authorisations,
the Commission may impose temporary safety restrictions on the marketing
authorisation holder, including suspending the marketing authorisation and/or
prohibiting the supply of a veterinary medicinal product. Other Member States and, where the temporary safety restriction is imposed by a competent
authority, the Commission shall be informed of the temporary safety restriction
imposed on the following working day at the latest.

2.           Member States and the Commission may refer the issue to the Agency in accordance with Article 84.

3.           Where applicable, the marketing
authorisation holder shall submit an application for a variation to the terms
of the marketing authorisation in accordance with Article 61.

Article 131
Suspending, withdrawing or varying marketing authorisations

1.           The competent authority or
the Commission shall suspend or withdraw the marketing authorisation if the
benefit-risk balance of the veterinary medicinal product is unfavourable.

2.           The competent authority or
the Commission shall suspend or withdraw the marketing authorisation or request
the marketing authorisation holder to submit an application for a variation to
the terms of the marketing authorisation where the withdrawal period is
inadequate to ensure that foodstuffs obtained from the treated animal do not
contain residues which might constitute a public health hazard.

3.           The competent authority or
the Commission may suspend or withdraw the marketing authorisation or request
the marketing authorisation holder to submit an application for a variation to
the terms of the marketing authorisation in case of any of the following:

(a) 
the marketing authorisation holder does not
comply with the requirements set out in Article 55;

(b) 
the marketing authorisation holder does not
comply with the requirements set out in Article 129;

(c) 
the pharmacovigilance system required in
accordance with Article 72 is inadequate;

(d) 
the marketing authorisation holder does not
fulfil his obligations laid down in Article 77;

(e) 
the maximum residue limit for the active
substance established in accordance with Regulation (EC) No 470/2009 has been
amended.

4.           For the purpose of
paragraphs 1 to 3, before taking action, the Commission shall request, where
appropriate, the opinion of the Agency within time-limit which it shall
determine in the light of the urgency of the matter, in order to examine the
reasons. Whenever practicable, the holder of the marketing authorisation for
the veterinary medicinal product shall be invited to provide oral or written
explanations.

5.           Following an opinion by
the Agency, the Commission shall adopt, where necessary, provisional measures,
which shall be applied immediately. The Commission shall, by means of
implementing acts, take a final decision. Those implementing acts shall be
adopted in accordance with the examination procedure referred to in Article 145(2).

6.           Member States shall lay
down procedures for application of paragraphs 1 to 3.

Article 132
Suspending and withdrawing manufacturing authorisations

In the event of non-compliance with the
requirements laid down in Article 98, the competent authority shall take any of
the following measures:

(a) 
suspend manufacture of veterinary medicinal
products;

(b) 
suspend imports of veterinary medicinal products
from third countries;

(c) 
suspend the manufacturing authorisation for a
category of preparations or for all preparations;

(d) 
withdraw the manufacturing authorisation for a
category of preparations or for all preparations.

Article 133
Prohibiting supply of veterinary medicinal products

1.           In duly justified cases, the
competent authority or the Commission shall prohibit the supply of a veterinary
medicinal product and require the marketing authorisation holder to withdraw
the veterinary medicinal product from the market if any of the following apply:

(a) 
the benefit-risk balance of the veterinary medicinal
product is unfavourable;

(b) 
the qualitative and quantitative composition of
the veterinary medicinal product is not as stated in the summary of the product
characteristics referred to in Article 30;

(c) 
the recommended withdrawal period is inadequate
to ensure that foodstuffs obtained from the treated animal do not contain
residues which might constitute a public health hazard;

(d) 
the control tests referred to in Article 129(1)
have not been carried out.

2.           The competent authorities
or the Commission may confine the prohibition on supply and withdrawal from the
market solely to the contested production batches.

Article 134
Penalties imposed by Member States

1.           Member States may impose
financial penalties on the holders of marketing authorisations granted under
this Regulation if they fail to observe their obligations in accordance with
this Regulation.

2.           Member States shall lay
down rules concerning the initiation, duration, time-limits and conduct of the
imposition of fines or periodic penalty payments to the holders of marketing
authorisations granted under this Regulation, the maximum amounts of these
penalties as well as the conditions and methods for their collection. The
penalties provided for must be effective, dissuasive and proportionate to the
nature, duration and seriousness of the infringement as well as to the damage
caused to public health, animal health and the environment.

3.           Member States shall notify
those provisions to the Commission by [Publications Office: insert date
counting 36 months from the date of entry into force of this Regulation] and
shall notify it without delay of any subsequent amendments affecting them.

4.           Where the Member State imposes a financial penalty, it shall publish a concise summary of the case,
including the names of the marketing authorisation holders involved and the
amounts of and reasons for the financial penalties imposed, having regard to
the legitimate interest of the marketing authorisation holders in the
protection of their business secrets.

Article 135
Penalties imposed by the Commission

1.           The Commission may impose
financial penalties on the holders of marketing authorisations granted under
this Regulation if they fail to observe their obligations in accordance with
this Regulation.

2.           The Commission shall be
empowered to adopt delegated acts in accordance with Article 146 laying down
rules concerning the initiation, duration, time-limits and conduct of the
imposition of fines or periodic penalty payments to the holders of marketing
authorisations granted under this Regulation, the maximum amounts of these
penalties as well as the conditions and methods for their collection.

3.           Where the Commission
adopts a decision imposing a financial penalty, it shall publish a concise
summary of the case, including the names of the marketing authorisation holders
involved and the amounts of and reasons for the financial penalties imposed,
having regard to the legitimate interest of the marketing authorisation holders
in the protection of their business secrets.

4.           The Court of Justice shall
have unlimited jurisdiction to review decisions whereby the Commission has
imposed financial penalties. It may cancel, reduce or increase the fine or
periodic penalty payment imposed.

Chapter X
Regulatory network

Article 136
Competent authorities

1.           Member States shall
designate the competent authorities to carry out tasks under this Regulation.

2.           The competent authorities
shall cooperate with each other in the performance of their tasks under this
Regulation and shall give the competent authorities of other Member States
necessary and useful support to this end. Competent authorities shall
communicate the appropriate information to each other, particularly regarding
compliance with the requirements for the manufacturing and wholesale
distribution authorisations, for the certificates of good manufacturing
practice or for marketing authorisations.

3.           Upon reasoned request, the
competent authorities shall forthwith communicate the reports referred to in Article
125 and Article 129 to the competent authorities of other Member States.

4.           Member States shall
communicate to each other all the information necessary to guarantee the
quality and safety of homeopathic veterinary medicinal products manufactured
and marketed within the Union.

Article 137
Information to the Agency and international organisations from the competent
authorities

1.           Each competent authority
shall immediately inform the Agency of all decisions granting marketing
authorisation and of all decisions refusing or withdrawing marketing
authorisation, repealing a decision refusing or withdrawing marketing
authorisation, prohibiting supply or withdrawing a product from the market,
together with the reasons on which such decisions are based.

2.           The competent authorities
shall forthwith bring to the attention of the relevant international organisations,
with a copy to the Agency, all appropriate information about actions taken
pursuant to paragraph 1 which may affect the protection of health in third
countries.

Article 138
Scientific opinion for international organisations for animal health

1.           The Agency may give
scientific opinions, in the context of cooperation with international
organisations for animal health, for the evaluation of veterinary medicinal
products intended exclusively for markets outside the Union. For this purpose,
an application shall be submitted to the Agency in accordance with the
provisions of Article 7. The Agency may, after consulting the relevant
organisation, draw up a scientific opinion.

2.           The Committee shall
establish specific procedural rules for the application of paragraph 1.

Article 139
Committee for Medicinal Products for Veterinary Use

1.           A Committee for Medicinal
Products for Veterinary Use (‘the Committee’) is hereby set up within the
Agency.

2.           The Executive Director of
the Agency or his representative and representatives of the Commission shall be
entitled to attend all meetings of the Committee, working parties and
scientific advisory groups and all other meetings convened by the Agency or its
committees.

3.           The Committee may
establish standing and temporary working parties. The Committee may establish
scientific advisory groups in connection with the evaluation of specific types
of medicinal products or treatments, to which the Committee may delegate
certain tasks associated with drawing up the scientific opinions referred to in
Article 141(1)(b).

4.           The Committee shall
establish a standing working party with the sole remit of providing scientific
advice to undertakings. The Executive Director, in close consultation with the
Committee shall set up the administrative structures and procedures allowing
the development of advice for undertakings, as referred to in Article 57(1)(n)
of Regulation (EC) No 726/2004, particularly regarding the development of new
therapies.

5.           The Committee shall
establish its own rules of procedure. Those rules shall, in particular, lay
down:

(a) 
procedures for appointing and replacing the
Chairman;

(b) 
the appointment of members of any working
parties or scientific advisory groups on the basis of the lists of experts
referred to in the second subparagraph of Article 62(2) of Regulation (EC) No
726/2004 and procedures for consultation of working parties and scientific advisory
groups;

(c) 
a procedure for urgent adoption of opinions,
particularly in relation to the provisions of this Regulation on market
surveillance and pharmacovigilance.

The rules of procedure shall enter into
force after receiving a favourable opinion from the Commission and the
Management Board of the Agency.

6.           The Secretariat of the
Agency shall provide technical, scientific and administrative support for the
Committee, and shall ensure consistency and quality of opinions of the
Committee and appropriate coordination between this Committee, other committees
of the Agency and the coordination group.

7.           The opinions of the
Committee shall be publicly accessible.

Article 140
Members of the Committee for Medicinal Products for Veterinary Use

1.           Each Member State shall be
entitled to appoint a Member and an alternate Member of the Committee. The
alternates shall represent and vote for the Members in their absence and may
act as rapporteurs.

2.           Members and alternate
Members of the Committee shall be appointed on the basis of their relevant
expertise and experience in the scientific evaluation of medicinal products for
veterinary use, in order to guarantee the highest level of qualifications and a
broad spectrum of relevant expertise.

3.           Member States shall submit
relevant information to the Management Board of the Agency on expertise and
experience in relation to the scientific profile established by the Committee
of experts that the Member States consider for appointment for a position in
the Committee.

4.           The Management Board shall
evaluate information on the expert or experts submitted by the Member State and shall communicate its conclusions to the Member State and the Committee.

5.           Taking into account the
conclusions referred to in paragraph 4, each Member State shall appoint one
Member and one alternate to the Committee for a three-year term which may be
renewed.

6.           A Member State may
delegate its tasks within the Committee to another Member State. Each Member State may represent no more than one other Member State.

7.           The Committee may co-opt a
maximum of five additional members chosen on the basis of their specific scientific
competence. These members shall be appointed for a term of three years, which
may be renewed, and shall not have alternates.

8.           With a view to the
co-opting of such members, the Committee shall identify the specific
complementary scientific competence of the additional member(s). Co-opted
members shall be chosen among experts nominated by Member States or the Agency.

9.           The members of the
Committee may be accompanied by experts in specific scientific or technical
fields.

10.         Members of the Committee
and experts responsible for evaluating veterinary medicinal products shall rely
on the scientific evaluation and resources available to competent authorities.
Each authority shall monitor and ensure the scientific level and independence
of the evaluation carried out and the provision of appropriate contribution to
the tasks of the Committee, and facilitate the activities of appointed
Committee members and experts. To this end, Member States shall provide
adequate scientific and technical resources to the members and experts they
have nominated.

11.         Member States shall refrain
from giving Committee members and experts instructions incompatible with their
own individual tasks, or with the tasks of the Committee and responsibilities
of the Agency.

Article 141
Tasks of the Committee for Medicinal Products for Veterinary Use

1.           The Committee shall have
the following tasks:

(a) 
carry out the tasks conferred on the Committee
under this Regulation and Regulation (EC) No 726/2004;

(b) 
prepare opinions of the Agency on questions
relating to the evaluation and use of veterinary medicinal products;

(c) 
upon request from the Executive Director of the
Agency or the Commission draw up opinions on scientific matters concerning the
evaluation and use of veterinary medicinal products;

(d) 
draw up opinions of the Agency on questions
concerning the admissibility of files submitted in accordance with the
centralised procedure, and on granting, varying, suspending or withdrawing a
marketing authorisations for centrally authorised veterinary medicinal
products;

(e) 
take due account of any request from Member
States for opinions;

(f) 
formulate opinions whenever there is a request
for a scientific re-examination in the course of mutual recognition or
decentralised procedures;

(g) 
provide guidance on important questions and
issues of general scientific or ethical nature

(h) 
give a scientific opinion, in the context of
cooperation with international organisations for animal health, concerning the
evaluation of certain veterinary medicinal products or active substances
intended exclusively for markets outside the Union.

2.           The members of the
Committee shall ensure that there is appropriate coordination between the tasks
of the Agency and the work of competent authorities.

3.           When preparing opinions
the Committee shall use its best endeavours to reach a scientific consensus. If
such consensus cannot be reached, the opinion shall consist of the position of
the majority of members and divergent positions, with the grounds on which they
are based.

4.           If there is a request for
re-examination of an opinion where this possibility is provided for in the
Union law, the Committee shall appoint a different rapporteur and, where
necessary, a different co-rapporteur from those appointed for the opinion. The
re-examination procedure may deal only with the points of the opinion initially
identified by the applicant and may be based only on the scientific data
available when the Committee adopted the opinion. The applicant may request
that the Committee consults a scientific advisory group in connection with the
re-examination.

Article 142
 Coordination group for mutual recognition and decentralised procedures for
veterinary medicinal products

1.           The coordination group for
mutual recognition and decentralised procedures for veterinary medicinal
products ("the coordination group") is hereby set up.

2.           The Agency shall provide a
secretariat for the coordination group, which shall ensure effective and
efficient operation of the procedures of the coordination group and appropriate
liaison between this group, the Agency and national competent authorities.

3.           The coordination group
shall draw up its rules of procedure, which shall enter into force after
receiving a favourable opinion from the Commission. These rules of procedure
shall be made public.

4.           The Executive Director of
the Agency or his representative and representatives of the Commission shall be
entitled to attend all meetings of the coordination group.

5.           The coordination group
shall ensure that there is appropriate cooperation and coordination between the
group, the competent authorities and the Agency.

Article 143
Members of the Coordination group for mutual recognition and decentralised
procedures for veterinary medicinal products

1.           The coordination group
shall be composed of one representative per Member State appointed for a
renewable period of 3 years. Members of the group may arrange to be accompanied
by experts.

2.           Members of the
coordination group and their experts shall rely on the scientific and
regulatory resources available to their competent authorities on relevant
scientific assessments and on the recommendations of the Committee for the
fulfilment of their tasks. Each national competent authority shall monitor the
quality of the evaluations carried out by their representative and facilitate
their activities.

3.           Members of the
coordination group shall use their best endeavours to reach consensus on
matters under discussion. If such consensus cannot be reached, the position of
the simple majority of the members of the coordination group shall prevail.

Article 144
Tasks of the Coordination group for mutual recognition and decentralised
procedures for veterinary medicinal products

The coordination group shall have the
following tasks:

(a) 
examine questions concerning mutual recognition
and decentralised procedures;

(b) 
examine questions concerning pharmacovigilance
of veterinary medicinal products authorised in Member States;

(c) 
examine questions concerning variations to the terms
of marketing authorisations granted by Member States;

(d) 
provide recommendations to Member States whether
a substance or a combination of substances is to be considered a veterinary
medicinal product within the scope of this Regulation.

Chapter XI
Final provisions

Article 145
Standing Committee on Veterinary Medicinal Products

1.           The Commission shall be
assisted by the Standing Committee on Veterinary Medicinal Products (‘the
Standing Committee’). The Standing Committee shall be a committee within the
meaning of Regulation (EU) No 182/2011.

2.           Where reference is made to
this paragraph, Article 5 of Regulation (EU) No 182/2011shall apply.

Article 146
Exercise of the delegation

1.           The power to adopt
delegated acts is conferred on the Commission subject to the conditions laid
down in this Article.

2.           The power to adopt
delegated acts referred to in Articles 7(7), 16(6), 32(3), 38(4), 54(3), 89(2),
117(2) and 135(2) shall be conferred on the Commission for an indeterminate
period of time from the date of the entry into force of this Regulation.

3.           The delegation of power
referred to in Articles 7(7), 16(6), 32(3), 38(4), 54(3), 89(2), 117(2) and 135(2)
may be revoked at any time by the European Parliament or by the Council. A
decision to revoke shall put an end to the delegation of the power specified in
that decision. It shall take effect the day following the publication of the
decision in the Official Journal of the European Union or at a later
date specified therein. It shall not affect the validity of any delegated acts
already in force.

4.           As soon as it adopts a
delegated act, the Commission shall notify it simultaneously to the European
Parliament and to the Council.

5.           A delegated act adopted
pursuant to Articles 7(7), 16(6), 32(3), 38(4), 54(3), 89(2), 117(2) and 135(2)
shall enter into force only if no objection has been expressed either by the
European Parliament or the Council within a period of two months of
notification of that act to the European Parliament and the Council or if,
before the expiry of that period, the European Parliament and the Council have
both informed the Commission that they will not object. That period shall be
extended by two months at the initiative of the European Parliament or of the
Council.

Article 147
Data protection

1.           Member States shall apply
Directive 95/46/EC to the processing of personal data carried out in the Member
States pursuant to this Regulation.

2.           Regulation (EC) No 45/2001
shall apply to the processing of personal data carried out by the Commission
and the Agency pursuant to this Regulation.

Article 148
Repeal

Directive 2001/82/EC is repealed.

References to the repealed Directive shall
be construed as references to this Regulation and shall be read in accordance
with the correlation table set out in Annex IV.

Article 149
Transitional provisions

1.           Applications for marketing
authorisations for veterinary medicinal products submitted in accordance with
Regulation (EC) No 726/2004 before the date of application of this Regulation
shall be examined in accordance with Regulation (EC) No 726/2004.

2.           Applications for marketing
authorisations for veterinary medicinal products submitted in accordance with
the requirements of Directive 2001/82/EC before the date of application of this
Regulation shall be examined in accordance with Directive 2001/82/EC.

3.           Procedures initiated on
the basis of Articles 33, 34, 35, 39, 40 and 78 of Directive 2001/82/EC before
the date of application of this Regulation shall be completed in accordance
with Directive 2001/82/EC.

Article 150
Entry into force

This Regulation shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.

It shall apply from [Office of
Publications please insert date counting 24 months from the entry into force]
except for Article 15, Article 54(4), Article 58(2), Article 108(4) and Article
116(4) which shall apply from the date of entry into force of this Regulation.

This Regulation shall be binding
in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament                        For
the Council

The President                                                 The
President

LEGISLATIVE
FINANCIAL STATEMENT

1.           FRAMEWORK OF THE
PROPOSAL/INITIATIVE

1.1.    Title of the proposal/initiative

1.2.    Policy
area(s) concerned in the ABM/ABB structure

1.3.    Nature
of the proposal/initiative

1.4.    Objective(s)

1.5.    Grounds
for the proposal/initiative

1.6.    Duration
and financial impact

1.7.    Management
mode(s) planned

2.           MANAGEMENT MEASURES

2.1.    Monitoring
and reporting rules

2.2.    Management
and control system

2.3.    Measures
to prevent fraud and irregularities

3.           ESTIMATED FINANCIAL
IMPACT OF THE PROPOSAL/INITIATIVE

3.1.    Heading(s)
of the multiannual financial framework and expenditure budget line(s) affected

3.2.    Estimated
impact on expenditure

3.2.1. Summary of estimated
impact on expenditure

3.2.2. Estimated impact
on operational appropriations

3.2.3. Estimated impact
on appropriations of an administrative nature

3.2.4. Compatibility
with the current multiannual financial framework

3.2.5. Third-party
contributions

3.3.    Estimated impact on revenue

LEGISLATIVE FINANCIAL STATEMENT

1.           FRAMEWORK OF THE
PROPOSAL/INITIATIVE

1.1.        Title of the
proposal/initiative

Proposal for a Regulation of the European Parliament
and of the Council on  veterinary medicinal products

1.2.        Policy area(s) concerned
in the ABM/ABB structure[33]

Heading 3: Security and Citizenship

Public health, animal health and food safety.

1.3.        Nature of the
proposal/initiative

X The proposal/initiative relates to a new action

 ̈ The
proposal/initiative relates to a new action following a pilot
project/preparatory action[34]

 ̈ The
proposal/initiative relates to the extension of an existing action

 ̈ The
proposal/initiative relates to an action redirected towards a new action

1.4.        Objective(s)

1.4.1.     The Commission's
multiannual strategic objective(s) targeted by the proposal/initiative

Smart and
inclusive growth (competitiveness for growth and jobs) and security and
citizenship (public health and consumer protection)

1.4.2.     Specific objective(s) and
ABM/ABB activity(ies) concerned

Specific objective

The general objective of this proposal is to ensure a high level of
public health protection, high standards of quality and safety of veterinary medicinal products and the optimal
functioning of the internal market. Specific objectives are to expand the
market beyond the top four animal species, to simplify procedures for obtaining
a marketing authorisation in multiple national markets, review data
requirements in marketing authorisation procedures, simplify post authorisation
requirements and review incentives for breakthrough medicines.

ABM/ABB activity(ies) concerned

To expand the market beyond the top four
animal species, to simplify procedures for obtaining a marketing authorisation
in multiple national markets, review data requirements in marketing
authorisation procedures, simplify post authorisation requirements and review
incentives for breakthrough medicines.

1.4.3.     Expected result(s) and
impact

Specify the effects
which the proposal/initiative should have on the beneficiaries/groups targeted.

The main
effects of the proposal are a simplified regulatory environment and reduced
administrative burden whilst maintaining safeguards to ensure public and animal
health, and safety to the environment and allowing more accessible use of
medicines, stimulating the development of new medicines and facilitating the
circulation of veterinary medicinal products across the EU.

The
proposal also tackles the issue of antimicrobial resistance and introduces
provisions to minimise risks to public health arising from the use of
antimicrobials in veterinary medicine.

Effects on
the pharmaceutical industry, wholesalers and importers: reduction of
administrative burdens regarding authorisation of veterinary medicinal products and keeping them on the
market; support to innovation.

Effects on
veterinarians, farmers and companion animal owners: increased availability of
veterinary medicinal products and
greater accessibility of medicines.

1.4.4.     Indicators of results and
impact

Specify the
indicators for monitoring implementation of the proposal/initiative.

Number of new veterinary medicinal products authorised

Number of applications submitted by SMEs

Numbers of variations submitted

Ratio of number of marketing authorisations for generics and
innovative products

Number of extensions of existing marketing authorisation to new
animal species

Sales of antimicrobials used in veterinary medicinal
products

Number of referrals on veterinary antimicrobials

1.5.        Grounds for the proposal/initiative

1.5.1.     Requirement(s) to be met in
the short or long term

The
legislation on veterinary medicinal products has been criticised by the pharmaceutical industry, veterinary
surgeons, farmers and general public organisations as not adequate to the needs
of the veterinary sector. These stakeholders have indicated that the current
legislation is disproportionate and burdensome, and not conducive to
innovation. This causes an overall problem regarding availability of veterinary
medicinal products in the Union, for minor species, for rare or emerging diseases and for the treatment and
prevention of some diseases in major species. This lack of authorised
veterinary medicinal products poses
significant problems, e.g. poorer animal health and welfare, increased risk for
human health, and economic and competitive disadvantage for EU farming.

The requirement is to review the legislation to modernise it and
make it tailor-made to the needs of the sector.

1.5.2.     Added value of EU
involvement

The current EU legislation on veterinary medicinal
products provides the legal environment on
authorisation, production, marketing, distribution and use of veterinary
medicinal products . It brought some harmonisation to the procedures and rules
required to place veterinary medicinal products  on the EU market but there is
evidence that the existing provisions do not deliver a functioning internal
market. Diverging or incomplete transposition of the rules and the existence of
numerous national requirements imply that companies are confronted with
different rules and interpretation in countries and have also led to different
levels of public and animal health protection. It is critically important to
have a single market for veterinary medicinal products  as the veterinary pharmaceutical
sector is driven by commercial returns obtained through the sales of veterinary
medicinal products  on the resources spent. The current confined and fragmented
markets do not allow the pharmaceutical sector to have a positive return on
investments for developing new products for certain animal species. The
ambition to improve the availability of medicines in the Union and the
functioning of the internal market and market competition can only be carried
out at EU level. Ultimately, this would benefit animal and human health across
the Union.

1.5.3.     Lessons learned from
similar experiences in the past

Some
elements of the present initiative build on the experiences gained throughout
the years in the area of the authorisation of veterinary medicinal products .
The proposal is based on a study assessing the impact of the revision of the
veterinary pharmaceutical legislation (available at ec.europa.eu/health/files/veterinary/11-07-2011_final_report.pdf)
and feedback from public consultation that took place from April to July 2010.

1.5.4.     Compatibility and possible
synergy with other appropriate instruments

Synergy is
expected with the revision of the legislation on medicated feed, the proposal
for a regulation on official controls to ensure the application of food and
feed law, rules on animal welfare, plant reproductive material, plant
protection products, proposal for a regulation on animal health, the Regulation
(EC) No 470/2009 for the establishment of residue limits of pharmacologically
active substances in foodstuffs of animal origin, Council Regulation (EC) No
297/95 on fees payable to the European Medicines Agency (EMA) and Regulation
(EC) No 726/2004 laying down Community procedures for the authorisation and the
supervision of medicinal products for human and veterinary use.

1.6.        Duration and financial
impact

 ̈ Proposal/initiative of limited
duration

– 
 ̈  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY

– 
 ̈  Financial impact from YYYY to YYYY

X Proposal/initiative of unlimited
duration

– 
Implementation with a start-up period of 24
months (the start-up period is the time between date of entry into force of the
Regulation,  20 days after its publication, and the date of application of the
Regulation).  During this time all implementation measures have to be taken by
the Commission in order to ensure that the Regulation can function on the day
of application of the Regulation). The start-up period is followed by
full-scale operation.

1.7.              Management mode(s) planned[35]

From the
2014 budget

X Direct management by the
Commission

– 
 ̈ by its departments, including by its staff in the Union
delegations;

– 
 ̈  by the executive agencies

 ̈ Shared management with the Member States

X Indirect management by
entrusting budget implementation tasks to:

– 
 ̈ third countries or the bodies they have designated;

– 
 ̈ international organisations and their agencies (to be specified);

– 
 ̈the EIB and the European Investment Fund;

– 
 ̈ bodies referred to in Articles 208 and 209 of the Financial
Regulation;

– 
 ̈ public law bodies;

– 
 ̈ bodies governed by private law with a public service mission to the
extent that they provide adequate financial guarantees;

– 
X bodies governed by the private law of a Member
State that are entrusted with the implementation of a public-private
partnership and that provide adequate financial guarantees;

– 
 ̈ persons entrusted with the implementation of specific actions in
the CFSP pursuant to Title V of the TEU, and identified in the relevant basic
act.

– If more than one management mode is
indicated, please provide details in the ‘Comments’ section.

Comments

2.           MANAGEMENT MEASURES

2.1.        Monitoring and reporting
rules

Specify frequency
and conditions.

The
Commission has established mechanisms for working with the Member States to
monitor implementation of the EU acquis in the area of veterinary
medicinal products regulation. The Agency will provide the Commission and the
Management Board yearly information relating to veterinary activities.
'Veterinary Pharmaceutical Committee' and the co-ordination group of Member
States (CMDv) will be the main forum for the monitoring and assessment of the
application of the new Regulation. In order to evaluate the implementation and
effects of the new rules, the indicators as set out in 1.4.4 will be gathered
and monitored at regular intervals.

2.2.        Management and control
system

2.2.1.     Risk(s) identified

The Agency
may have insufficient fee income given the difficulty to predict the exact
frequency, scope and costs of all the veterinary activities at the Agency.
Moreover, the required resources for the European Medicines Agency are foreseen
by a review of the fees charged for veterinary medicinal products. It is
necessary that the new fee structure would be in place on time.

The updated EU databases for veterinary medicinal products and
pharmacovigilance may not meet the requirements of the users (authorities and
marketing authorisation holders). Thus, the revision of the rules would not
provide the reduction in burden it intends to achieve.

2.2.2.     Information concerning the
internal control system set up

The
competent authority of a Member State has the responsibility to ensure, by
means of inspections, that the legal requirements relating to veterinary
medicinal products are complied with in the Member State. The Commission will audit the control systems of the Member States.

Moreover,
monitoring will take place to ensure that the fee resources correspond with the
additional tasks of the Agency and on an annual basis the required staff levels
and resources will be reviewed.

Close and
regular contacts with the developers of the IT tools should ensure that
databases meet the requirements of users.

2.2.3.     Estimate of the costs and
benefits of the controls and assessment of the expected level of risk of error

Costs of
audits of the Commission will be limited as these will be integrated in the
audits of the Commission's Food and Veterinary Office (FVO) on the monitoring
of residues in live animals and animal products in Member States. The objective
of the audit will be the implementation by the competent authority of the
responsibility to ensure, by means of inspections, that the legal requirements
relating to veterinary medicinal products are complied with in the Member State.  The audits will assess the performance of the competent authority and other
officially authorised entities involved in controls as well as the legal and
administrative measures put in place to give effect to the EU requirements.

The
expected level of risk of error is low because in the current legislation
Member States already have the same responsibility. Audits of the Commission
will lead to further improvement and harmonisation of control systems in Member
States.

2.3.        Measures to prevent fraud
and irregularities

Specify existing or
envisaged prevention and protection measures.

[In addition to the application of all
regulatory control mechanisms, DG SANCO will devise an anti-fraud strategy in
line with the Commission's anti-fraud strategy (CAFS) adopted on 24 June 2011
in order to ensure inter alia that its internal anti-fraud related
controls are fully aligned with the CASF and that its fraud risk management
approach is geared to identify fraud risk areas and adequate responses. Where
necessary, networking groups and adequate IT tools dedicated to analysing fraud
cases related to the financing implementing activities of the Veterinary
Medicinal Products Regulation will be set up. In particular a series of
measures will be put in place such as:  
- decisions, agreements and contracts resulting from the financing implementing
activities of the Regulation will expressly entitle the Commission, including
OLAF, and the Court of Auditors to conduct audits, on-the-spot checks and
inspections;          
- during the evaluation phase of a call for proposals/tender, the proposers and
tenderers are checked against the published exclusion criteria based on
declarations and the Early Warning System (EWS);  
- the rules governing the eligibility of costs will be simplified in accordance
with the provisions of the Financial Regulation;      
- regular training on issues related to fraud and
irregularities is given to all staff involved in contract management as well as
to auditors and controllers who verify the beneficiaries' declarations on the
spot.

3.           ESTIMATED FINANCIAL
IMPACT OF THE PROPOSAL/INITIATIVE

3.1.        Heading(s) of the
multiannual financial framework and expenditure budget line(s) affected

· Existing budget lines

In order of
multiannual financial framework headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Heading.............................................] || Diff./Non-diff.[36] || from EFTA countries[37] || from candidate countries[38] || from third countries || within the meaning of Article 21(2)(b) of the Financial Regulation

3 || 17.0312 - EMA || Diff./Non-diff. || YES || NO || NO || NO

The annual
subsidy to the EMA is paid under this budget line. However, all activities
under this proposal are considered to be fee-financed. Consequently, no
additional impact is foreseen of this proposal on the budget of the EU.

· New budget lines requested  - NOT APPLICABLE

In order of
multiannual financial framework headings and budget lines.

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Heading.............................................] || Diff./Non-diff. || from EFTA countries || from candidate countries || from third countries || within the meaning of Article 21(2)(b) of the Financial Regulation

|| [XX.YY.YY.YY] || || YES/NO || YES/NO || YES/NO || YES/NO

3.2.        Estimated impact on
expenditure

[This section should
be filled in using the spreadsheet on budget data of an
administrative nature
(second document in annex to this financial statement) and uploaded to CISNET
for interservice consultation purposes.]

3.2.1.     Summary of estimated impact
on expenditure

EUR million (to three decimal places)

Heading of multiannual financial framework || Number || [Heading...........................................................................................]

DG: <.......> || || || Year N[39] || Year N+1 || Year N+2 || Year N+3 || Enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL

Ÿ Operational appropriations || || || || || || || ||

Number of budget line || Commitments || (1) || || || || || || || ||

Payments || (2) || || || || || || || ||

Number of budget line || Commitments || (1a) || || || || || || || ||

Payments || (2a) || || || || || || || ||

Appropriations of an administrative nature financed from the envelope of specific programmes[40] || || || || || || || ||

Number of budget line || || (3) || || || || || || || ||

TOTAL appropriations for DG <.......> || Commitments || =1+1a +3 || || || || || || || ||

Payments || =2+2a +3 || || || || || || || ||

Ÿ TOTAL operational appropriations || Commitments || (4) || || || || || || || ||

Payments || (5) || || || || || || || ||

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || || || || ||

TOTAL appropriations under HEADING <....> of the multiannual financial framework || Commitments || =4+ 6 || || || || || || || ||

Payments || =5+ 6 || || || || || || || ||

If more than one heading is affected by the proposal /
initiative:

Ÿ TOTAL operational appropriations || Commitments || (4) || || || || || || || ||

Payments || (5) || || || || || || || ||

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || || || || ||

TOTAL appropriations under HEADINGS 1 to 4 of the multiannual financial framework (Reference amount) || Commitments || =4+ 6 || || || || || || || ||

Payments || =5+ 6 || || || || || || || ||

Heading of multiannual financial framework || 5 || ‘Administrative expenditure’

EUR million (to three decimal places)

|| || || Year N || Year N+1 || Year N+2 || Year N+3 || Enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL

DG: <.......> ||

Ÿ Human resources || || || || || || || ||

Ÿ Other administrative expenditure || || || || || || || ||

TOTAL DG <.......> || Appropriations || || || || || || || ||

TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || || || || || || || ||

EUR million (to three decimal places)

|| || || Year N[41] || Year N+1 || Year N+2 || Year N+3 || Enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL

TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework || Commitments || || || || || || || ||

Payments || || || || || || || ||

3.2.2.     Estimated impact on
operational appropriations

– 
X  The proposal/initiative does not require the
use of operational appropriations

– 
 ̈  The proposal/initiative requires the use of operational
appropriations, as explained below:

Commitment appropriations in EUR million (to three
decimal places)

Indicate objectives and outputs ò || || || Year N || Year N+1 || Year N+2 || Year N+3 || Enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL

OUTPUTS

Type[42] || Average cost || No || Cost || No || Cost || No || Cost || No || Cost || No || Cost || No || Cost || No || Cost || Total No || Total cost

SPECIFIC OBJECTIVE No 1[43]... || || || || || || || || || || || || || || || ||

- Output || || || || || || || || || || || || || || || || || ||

- Output || || || || || || || || || || || || || || || || || ||

- Output || || || || || || || || || || || || || || || || || ||

Subtotal for specific objective No 1 || || || || || || || || || || || || || || || ||

SPECIFIC OBJECTIVE No 2 ... || || || || || || || || || || || || || || || ||

- Output || || || || || || || || || || || || || || || || || ||

Subtotal for specific objective No 2 || || || || || || || || || || || || || || || ||

TOTAL COST || || || || || || || || || || || || || || || ||

3.2.3.     Estimated impact on
appropriations of an administrative nature

3.2.3.1.  Summary

– 
X  The proposal/initiative does not require the
use of appropriations of an administrative nature

– 
 ̈  The proposal/initiative requires the use of appropriations of an
administrative nature, as explained below:

EUR million (to
three decimal places)

|| Year N [44] || Year N+1 || Year N+2 || Year N+3 || Enter as many years as necessary to show the duration of the impact (see point 1.6) || TOTAL

HEADING 5 of the multiannual financial framework || || || || || || || ||

Human resources || || || || || || || ||

Other administrative expenditure || || || || || || || ||

Subtotal HEADING 5 of the multiannual financial framework || || || || || || || ||

Outside HEADING 5[45] of the multiannual financial framework || || || || || || || ||

Human resources || || || || || || || ||

Other expenditure of an administrative nature || || || || || || || ||

Subtotal outside HEADING 5 of the multiannual financial framework || || || || || || || ||

TOTAL || || || || || || || ||

The appropriations
required for human resources and other expenditure of an administrative nature
will be met by appropriations from the DG that are already assigned to
management of the action and/or have been redeployed within the DG, together if
necessary with any additional allocation which may be granted to the managing
DG under the annual allocation procedure and in the light of budgetary
constraints.

3.2.3.2.  Estimated requirements of
human resources

– 
X  The proposal/initiative does not require the
use of human resources.

– 
 ̈  The proposal/initiative requires the use of human resources, as
explained below:

Estimate to be expressed in full time
equivalent units

|| || Year N || Year N+1 || Year N+2 || Year N+3 || Enter as many years as necessary to show the duration of the impact (see point 1.6)

|| Ÿ Establishment plan posts (officials and temporary staff) || ||

|| XX 01 01 01 (Headquarters and Commission’s Representation Offices) || || || || || || ||

|| XX 01 01 02 (Delegations) || || || || || || ||

|| XX 01 05 01 (Indirect research) || || || || || || ||

|| 10 01 05 01 (Direct research) || || || || || || ||

Ÿ External staff (in Full Time Equivalent unit: FTE)[46] ||

|| XX 01 02 01 (AC, END, INT from the ‘global envelope’) || || || || || || ||

|| XX 01 02 02 (AC, AL, END, INT and JED in the delegations) || || || || || || ||

|| XX 01 04 yy [47] || - at Headquarters || || || || || || ||

|| - in Delegations || || || || || || ||

|| XX 01 05 02 (AC, END, INT - Indirect research) || || || || || || ||

|| 10 01 05 02 (AC, END, INT - Direct research) || || || || || || ||

|| Other budget lines (specify) || || || || || || ||

|| TOTAL || || || || || || ||

XX is the policy area or budget title
concerned.

The human resources
required will be met by staff from the DG who are already assigned to
management of the action and/or have been redeployed within the DG, together if
necessary with any additional allocation which may be granted to the managing
DG under the annual allocation procedure and in the light of budgetary
constraints.

Description of
tasks to be carried out:

Officials and temporary staff ||

External staff ||

3.2.4.     Compatibility with the
current multiannual financial framework

– 
X  The proposal/initiative is compatible the
current multiannual financial framework.

– 
 ̈  The proposal/initiative will entail reprogramming of the relevant
heading in the multiannual financial framework.

Explain what reprogramming is required,
specifying the budget lines concerned and the corresponding amounts.

The Commission Communication "Programming of
human and financial resources for decentralised agencies 2014-2020" (COM
(2013)519 final) lays down the Commission's resource plans for decentralised
agencies, including EMA, for the period 2014-2020. The human resources
requested in the present Legislative Financial Statement will be included in
the financial programming already envisaged in the Communication. EMA will be
invited to cover the additional activities required under this legal proposal
on veterinary medicinal products by internal redeployment.

– 
 ̈  The proposal/initiative requires application of the flexibility
instrument or revision of the multiannual financial framework.

Explain what is required, specifying the
headings and budget lines concerned and the corresponding amounts.

3.2.5.     Third-party contributions

– 
X The proposal/initiative does not provide for
co-financing by third parties.

– 
The proposal/initiative provides for the
co-financing estimated below:

Appropriations in EUR million (to three decimal
places)

|| Year N || Year N+1 || Year N+2 || Year N+3 || Enter as many years as necessary to show the duration of the impact (see point 1.6) || Total

Specify the co-financing body || || || || || || || ||

TOTAL appropriations co-financed || || || || || || || ||

3.3.        Estimated impact on
revenue

– 
X  The proposal/initiative has no financial
impact on revenue.

– 
 ̈  The proposal/initiative has the following financial impact:

– 
 ̈         on own resources

– 
 ̈         on miscellaneous revenue

EUR
million (to three decimal places)

Budget revenue line: || Appropriations available for the current financial year || Impact of the proposal/initiative[48]

Year N || Year N+1 || Year N+2 || Year N+3 || Enter as many years as necessary to show the duration of the impact (see point 1.6)

Article ............. || || || || || || || ||

For miscellaneous
‘assigned’ revenue, specify the budget expenditure line(s) affected.

Specify the method for
calculating the impact on revenue.

Annex:
Estimate of costs and income of European Medicines Agency

It is foreseen that the entire cost
relating to veterinary medicinal products activities in the European Medicines
Agency related to the revision is recouped through fees. Cost estimations and
calculations in this Annex are based on this principle and, therefore, the
proposal is not expected to have any financial impact on the budget of the EU.
The proposal empowers the Commission to adopt delegated acts to amend fees.
This would allow the Commission to adapt the fee structure in-time to the
agreement of European Parliament and Council on this proposal.

The costs are based on a qualitative analysis
of the expected change in seven areas of activity after implementation of the
regulation: pre-authorisation activities (e.g. scientific advice), evaluation
activities (marketing authorisation applications) post-authorisation activities
(variations), arbitration and referral, monitoring activities
(pharmacovigilance), other specialised areas and activities (advice to the
Commission, international cooperation, surveillance of the use of veterinary
antimicrobials,  transparency) and inspections and compliance. The table below
provides the estimate of the incremental costs and income of the implementation
of the current legislative proposal.

The cost estimations comprise salary cost,
evaluation cost, scientific meetings direct costs, translation costs and IT
one-off costs and IT maintenance costs, and is the balance of the anticipated
change in costs and loss of fee income to EMA after implementation of the
revised regulation. Salary costs do not take into account inflation, exchange
rates and additional pension costs (applicable from 2016 for the
Agency).Evaluation cost concern the services provided by the National Competent
Authorities (costs of rapporteurs' assessment activities). The direct costs for
scientific meetings include the costs of travel and subsistence for delegates.
Translation costs are the direct costs to the Agency for translation of
opinions and other product-related documents.

For the income the revised implementing
rules to the Fee Regulation as of 1 April 2013 has been used. The estimations
do not take into account fee reductions that may be applied to stimulate the
development of medicines for minor use and minor species or for SMEs.

|| || || || ||

Estimate of costs and income for the EMA of implementing the revised rules || || || ||

|| || || || ||

Workload overview || || || || ||

|| || || || || in FTE

Workload (additional need for human resources) || 2017 || 2018 || 2019 || 2020 || 2021

FTE workload for AD function or equivalent || 0,95 || 3,92 || 7,76 || 8,72 || 8,82

FTE workload for AST function or equivalent || 0,56 || 1,57 || 3,31 || 4,07 || 4,07

|| || || || ||

Workload (savings on human resources) || || || || ||

FTE workload for AD function or equivalent || 0,95 || 0,95 || 0,95 || 0,95 || 0,95

FTE workload for AST function or equivalent || 3,9 || 3,9 || 3,9 || 3,9 || 3,9

|| || || || ||

Workload (net effect on human resources, needs less savings) || || || || ||

FTE workload for AD function or equivalent || 0 || 2,97 || 6,81 || 7,77 || 7,87

FTE workload for AST function or equivalent || -3,34 || -2,33 || -0,59 || 0,17 || 0,17

|| || || || ||

|| || || || ||

|| || || || ||

EMA Income and cost estimates due to the revision of the Veterinary medicinal products || || ||

|| || || || ||

|| || || || || in EUR

Costs (EUR) || 2017 || 2018 || 2019 || 2020 || 2021

Salary cost for AD function or equivalent (89.685 EUR/y) ||                         -   ||              266.364 ||              610.755 ||              696.852 ||              705.821

Salary cost for AST function or equivalent (55.988 EUR/y) || -           187.000 || -           130.452 || -             33.033 ||                  9.518 ||                  9.518

Evaluation cost ||              186.950 ||              344.650 ||              754.900 ||          1.062.300 ||          1.062.300

Testing and sampling ||                         -   ||                         -   ||                         -   ||                         -   ||                         -

Scientific meetings direct cost ||              173.547 ||              201.638 ||              238.365 ||              238.365 ||              238.365

Translations cost ||                14.268 ||              252.854 ||              519.976 ||              548.512 ||              548.512

IT one-off costs ||              700.000 ||                         -   ||                         -   ||                         -   ||                         -

IT maintenance costs (including running costs for ESVAC) ||              467.534 ||              769.664 ||              744.764 ||              744.764 ||              744.764

Total cost ||          1.355.299 ||          1.704.718 ||          2.835.727 ||          3.300.311 ||          3.309.280

|| || || || ||

Income || || || || ||

Estimated income from fees payable to the EMA ||          1.355.299 ||          1.704.718 ||          2.835.727 ||          3.300.311 ||          3.309.280

|| || || || ||

|| || || || ||

|| || || || ||

|| || || || ||

[1]        Council Directive 65/65/EEC of 26
January 1965 on the approximation of provisions laid down by Law, Regulation or
Administrative Action relating to proprietary medicinal products (OJ 22,
9.2.1965, p. 369–373).

[2]        Directive 2001/82/EC of the European
Parliament and of the Council of 6 November 2001 on the Community code relating
to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

[3]        Regulation (EC) No 726/2004 of the
European Parliament and of the Council of 31 March 2004 laying down Community
procedures for the authorisation and supervision of medicinal products for
human and veterinary use and establishing a European Medicines Agency (OJ L
136, 30.4.2004, p. 1).

[4]        Communication from the Commission to
the European Parliament pursuant to the second subparagraph of
Article 251(2) of the EC Treaty concerning the common position of the
Council on the adoption of a proposal for a Regulation of the European Parliament
and the Council laying down Community procedures for the establishment of
residue limits of pharmacologically active substances in foodstuffs of animal
origin, and repealing Regulation (EEC) No 2377/90 (COM(2008) 912,
8.1.2009).

[5]        Communication from the Commission to
the European Parliament and the Council on an Action Plan against the rising
threats of antimicrobial resistance (COM 2011/748, 15.11.2011).

[6]        Commission Communication on
honeybee health (COM 2010/714, 6.12.2010).

[7]        For a summary of the responses, see:
http://ec.europa.eu/health/files/veterinary/vet_pubcons_rep2011.pdf.

[8]        Study carried out by GHK Consulting,
a member of the European Policy Evaluation Consortium (EPEC), assisted by
Triveritas.

[9]               OJ C , , p. .

[10]             OJ C , , p. .

[11]             Directive 2001/82/EC of the European Parliament and of
the Council of 6 November 2001 on the Community code relating to veterinary
medicinal products (OJ L 311, 28.11.2001, p. 1).

[12]             Regulation (EC) No 726/2004 of the European Parliament
and of the Council of 31 March 2004 laying down Community procedures for the authorisation
and supervision of medicinal products for human and veterinary use and establishing
a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

[13]             COM(2010) 2020 final, 3.3.2010.

[14]             Commission Regulation (EU) No 37/2010 of 22 December
2009 on pharmacologically active substances and their classification regarding
maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p.
1).

[15]             Directive 2010/63/EU of the European Parliament and of
the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).

[16]             Regulation (EC) No 1049/2001 of the European Parliament
and of the Council of 30 May 2001 regarding public access to European
Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).

[17]             Communication from the Commission on the precautionary
principle, COM (2000) 1 (final).

[18]             Directive 2004/28/EC of the European Parliament and of
the Council of 31 March 2004 amending Directive 2001/82/EC on the Community
code relating to veterinary medicinal products (OJ L 136, 30.4.2004, p. 58).

[19]             Regulation (EU) No 182/2011 of the European Parliament
and of the Council of 16 February 2011 laying down the rules and general
principles concerning mechanisms for control by Member States of the
Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

[20]             Regulation (EC) No 1831/2003 of the European Parliament
and of the Council of 22 September 2003 on additives for use in animal
nutrition (OJ L 55, 28.3.2011, p. 13).

[21]             Regulation (EU) No 528/2012 of the European Parliament
and of the Council of 22 May 2012 concerning the making available on the market
and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

[22]             Regulation (EC) No 470/2009 of the European Parliament
and of the Council of 6 May 2009 laying down Community procedures for the
establishment of residue limits of pharmacologically active substances in
foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and
amending Directive 2001/82/EC of the European Parliament and of the Council and
Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L
152, 16.6.2009, p. 11).

[23]             Commission Regulation (EC) No 504/2008
of 6 June 2008 implementing Council Directives 90/426/EEC and 90/427/EEC as
regards methods for the identification of equidae (OJ L 149, 7.6.2008, p. 3).

[24]             Directive 2001/18/EC of the European Parliament and of
the Council of 12 March 2001 on the deliberate release into the environment of
genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L
106, 17.4.2001, p.1).

[25]             Commission Decision 2002/657/EC of 14 August 2002
implementing Council Directive 96/23/EC concerning the performance of
analytical methods and the interpretation of results, (OJ L 221, 17.8.2002, p.
8).

[26]             Council Directive 96/23/EC of
29 April 1996 on measures to monitor certain substances and residues thereof in
live animals and animal products and repealing Directives 85/358/EEC and
86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p.
10).

[27]             Commission Directive 91/412/EEC of 23 July 1991 laying
down the principles and guidelines of good manufacturing practice for
veterinary medicinal products (OJ L 228, 17/08/1991, p. 70).

[28]             Directive 98/34/EC of the European Parliament and of
the Council of 22 June 1998 laying down a procedure for the provision of
information in the field of technical standards and regulations and of rules on
Information Society services (OJ L 204, 21.7.1998, p. 37).

[29]             Directive 2000/31/EC of the European Parliament and of
the Council of 8 June 2000 on certain legal aspects of information society
services, in particular electronic commerce, in the Internal Market ('Directive
on electronic commerce') (OJ L 178, 17.7.2000, p. 1).

[30]             Directive 2001/83/EC of the European Parliament and of
the Council of 6 November 2001 on the Community code relating to medicinal
products for human use (OJ L 311, 28.11.2001, p. 67).

[31]             Regulation of the European Parliament and the Council
of..... on animal health (OJ L......).

[32]             Council Decision 94/358/EC of 16 June 1994 accepting,
on behalf of the European Community, the Convention on the elaboration of a
European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17).

[33]             ABM: activity-based management; ABB: activity-based
budgeting.

[34]             As referred to in Article 54(2)(a) or (b) of the
Financial Regulation.

[35]             Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html

[36]             Diff. = Differentiated appropriations / Non-diff. =
Non-differentiated appropriations.

[37]             EFTA: European Free Trade Association.

[38]             Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.

[39]             Year N is the year in which implementation of the
proposal/initiative starts.

[40]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former ‘BA’ lines), indirect research, direct research.

[41]             Year N is the year in which implementation of the
proposal/initiative starts.

[42]             Outputs are products and services to be supplied (e.g.:
number of student exchanges financed, number of km of roads built, etc.).

[43]             As described in point 1.4.2. ‘Specific objective(s)...’

[44]             Year N is the year in which implementation of the
proposal/initiative starts.

[45]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or
actions (former ‘BA’ lines), indirect research, direct research.

[46]             AC= Contract Staff; AL = Local Staff; END= Seconded
National Expert; INT = agency staff; JED= Junior Experts in Delegations.

[47]             Sub-ceiling for external staff covered by operational
appropriations (former ‘BA’ lines).

[48]             As regards traditional own resources (customs duties,
sugar levies), the amounts indicated must be net amounts, i.e. gross amounts
after deduction of 25 % for collection costs.

ANNEXES

to the proposal for a

REGULATION OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL

on veterinary medicinal products

ANNEX I

Administrative information referred to in Article 7(1)(a)

1. Applicant

1.1. Name or business name and address or
registered place of business of the person responsible for placing the product
on the market

1.2. Name and address of manufacturer (s)

1.3. Name and address of the sites involved
in the different stages of the manufacturing

1.4. Name and address of importer, if relevant

2. Identification of the veterinary
medicinal product

2.1. Proposed name of the veterinary
medicinal product

2.2. Active substances

2.3. Strength

2.4. Pharmaceutical form

2.5. Route of administration

2.6. Method of administration

2.7. Target species

3. Manufacturing and pharmacovigilance
information

3.1. Proof of a manufacturing authorisation

3.2. Identifier or reference number of
pharmacovigilance system master file

4. Product information

4.1. Draft summary of the product
characteristics drawn up in accordance with Article 30

4.2. Description of the final presentation
of the product, including packaging and labelling.

4.3. Draft text of the information to be
provided in the immediate packaging, outer packaging and the package leaflet in
accordance with Articles 9-14 of this Regulation.

5. Other information

5.1. List of countries in which a marketing
authorisation has been granted for the veterinary medicinal product

5.2. Copies of all the summaries of product
characteristics as included in the terms of marketing authorisations granted by
Member States, if relevant

5.3. List of countries in which an
application has been submitted or refused

5.4. List of countries where the veterinary
medicinal product is to be placed on the market, if relevant

5.5. Critical expert reports on quality,
safety and efficacy

ANNEX II

Technical requirements referred to in Article 7(1)(b)

PART 1 - Technical requirements for
veterinary medicinal products other than biologicals

1.1. INTRODUCTION

The technical documentation shall include a
detailed and full description of the tests, studies and trials conducted or
referred to, including the methods used. The data shall be relevant and of
sufficient quality to demonstrate the quality, safety and efficacy of the veterinary
product.

Data shall be sufficient to establish:

- the veterinary medicinal product’s dosage
for the various animal species, its pharmaceutical form, its method and route
of administration and its shelf life

- any precautionary and safety measures to
be taken when storing the veterinary medicinal product, administering it to
animals or disposing of waste, together with an indication of potential risks
that the veterinary medicinal product might pose to the environment, to public
and animal health;

- the withdrawal period in the case of
veterinary medicinal products intended for food-producing species;

- the therapeutic indications,
contra-indications and adverse events.

The application shall contain a description
of the testing methods employed by the manufacturer, the results of pharmaceutical
(physico-chemical, biological or microbiological) tests and safety tests,
including tests assessing the potential risks posed by the medicinal product
for the environment. In addition, results of residue tests, pre-clinical
studies and clinical trials shall also be submitted.

Where relevant, studies shall be submitted
providing information on the direct or indirect risks to human health, food
safety or animal health of the use of the antimicrobial product in animals, as
well as an assessment of the effects of risk mitigation measures proposed by
the applicant to limit antimicrobial resistance development.

Pharmacological tests, toxicological tests,
residue tests and safety tests shall be carried out in conformity with the
provisions related to good laboratory practice (GLP) laid down in Directive
2004/10/EC of the European Parliament and of the Council[1] and Directive 2004/9/EC
of the European Parliament and of the Council[2].

The environmental risk assessment connected
with the release of veterinary medicinal products containing or consisting of
Genetically Modified Organisms (GMOs) within the meaning of Article 2 of
Directive 2001/18/EC shall be provided in the dossier. The information shall be
presented in accordance with the provisions of Directive 2001/18/EC.

Experiments on animals other than clinical
trials shall be conducted in accordance with Directive 2010/63/EU.

The application shall, where necessary,
include information regarding pharmacovigilance system.

For applications submitted through the
centralised procedure, the formats made available by the Agency must be used
for the submission of the dossier.

1.2. QUALITY DOCUMENTATION

1.2.1. BASIC PRINCIPLES AND REQUIREMENTS

The quality data shall include for the
active substances and for the finished veterinary medicinal product the
following information:

- description of the manufacturing process,

- characterisation and properties,

- quality control procedures and
requirements,

- stability,

- description of the composition,

- development of the veterinary medicinal
product.

All test procedures shall fulfil the
criteria for analysis and control of the quality of the starting materials and
the finished product. The results of the validation studies shall be provided.

Information shall be submitted describing
all test procedures used in sufficiently precise detail for the tests to be
reproduced in control tests, carried out at the request of the competent
authority; any special apparatus and equipment having been used shall be
described in adequate detail.

The formulae of the laboratory reagents
shall be indicated, supplemented, if necessary, by the method of preparation.
Where test procedures are included in the European Pharmacopoeia or the
pharmacopoeia of a Member State, the description of test procedures may be
replaced by a detailed reference to the pharmacopoeia in question.

Where relevant, chemical and biological
reference material of the European Pharmacopoeia shall be used. If other
reference preparations and standards have been used, they shall be identified
and described in detail.

Where an active substance of the veterinary
medicinal product has been included in a medicinal product for human use
authorised in accordance with Directive 2001/83/EC, a quality overall summary
provided for in module 2, point 2.3. of the Annex I to this Directive may
replace the documentation related to the active substance or the product, as
appropriate.

Where the competent authority has publicly
announced that the chemical, pharmaceutical and biological/microbiological
information for the finished product may be included in the dossier in the
Common Technical Document (CTD) format laid down only, the detailed and
critical summary on the results of pharmaceutical tests required for the
manufacture of the veterinary medicinal product may be presented in the quality
overall summary format.

Where an application concerns limited
markets, the CTD format may be followed without prior agreement of the
competent authorities.

1.2.2. DATA SET REQUIREMENTS FOR QUALITY

A. Qualitative and quantitative
composition

A.1. Qualitative particulars of the
veterinary medicinal product

A.2. Qualitative particulars of the
container and its closure

A.3. Usual terminology

A.4. Quantitative particulars

A.5. Development pharmaceutics

B. Description of the manufacturing
method

C. Control of starting materials

C.1. Active Substances

(i) Active substances listed in
pharmacopoeias

(ii) Active substances not in a
pharmacopoeia

(iii) Physico-chemical characteristics
liable to affect bioavailability

C.2. Excipients

Documentation shall be submitted to show
that colouring matters for inclusion in veterinary medicinal products satisfy
the requirements of Directive 2009/35/EC of the European Parliament and of the
Council[3]
except where the application for a marketing authorisation concerns certain
veterinary medicinal products for topical use, such as insecticidal collars and
ear tags.

Documentation shall be submitted to show
that colouring matters used meet the purity criteria laid down in Commission
Directive 2008/128/EC[4].

C.3. Container-closure systems

(i) Active substance

(ii) Finished product

C.4. Substances of biological origin

D. Control tests carried out at
intermediate stages of the manufacturing process

E. Tests on the finished product

E.1. General characteristics of the
finished product

E.2. Identification and assay of active
substance(s)

E.3. Identification and assay of excipient
components

E.4. Safety tests

F. Stability tests

F.1. Active substances(s)

F.2. Finished product

1.3. SAFETY DOCUMENTATION

1.3.1. BASIC PRINCIPLES AND REQUIREMENTS

The safety documentation shall include an
assessment of:

(a) the potential toxicity of the
veterinary medicinal product and any risk of undesirable effects which may
occur under the proposed conditions of use in animals; these shall be evaluated
in relation to the severity of the pathological condition concerned;

(b) the potential harmful effects to humans
of residues of the veterinary medicinal product or active substance in
foodstuffs obtained from treated animals and any difficulties these residues
may create in the industrial processing of foodstuffs;

(c) the potential risks which may result
from the exposure of human beings to the veterinary medicinal product at any
stage of the lifecycle of the veterinary medicinal product.;

(d) the potential risks for the environment
resulting from the use of the veterinary medicinal product;

(e) the potential risks relating to the
development of antimicrobial resistance.

The safety documentation shall show that
mathematical and statistical procedures have been used in designing the pre-clinical
studies and clinical trials and in evaluating the results. Additionally,
information shall be provided regarding the therapeutic potential of the
product and about the hazards connected with its use.

In some cases it may be necessary to test
the metabolites of the parent compound where these represent the residues of
concern.

An excipient used in the pharmaceutical
field for the first time shall be treated like an active substance.

Where the veterinary medicinal product is
intended for use in food-producing animals, the residue documentation shall
show:

(a) to what extent, and for how long
residues of the veterinary medicinal product or its metabolites persist in the
edible tissues of the treated animal or in milk, eggs and/or honey obtained
therefrom;

(b) that it is possible to establish
realistic withdrawal periods which can be observed under practical farming
conditions;

(c) that the analytical method(s) used in
the residues depletion study are sufficiently validated to provide the
necessary reassurance that the residues data submitted are suitable as the
basis for a withdrawal period.

An environmental risk assessment shall be
submitted regarding any undesirable effects which the use of the veterinary
medicinal product may have on the environment and the risk of such effects. The
assessment shall also identify any precautionary measures which may be
necessary to reduce such risk.

This assessment shall normally be conducted
in two phases. The first phase of the assessment shall always be performed and
the second phase shall be performed if necessary. The details of the assessment
shall be provided in accordance with accepted guidance. The assessment shall
indicate the potential exposure of the environment to the product and the level
of risk associated with any such exposure taking into account in particular the
following items:

(a) the target animal species, and the
proposed pattern of use,

(b) the method of administration, in
particular the likely extent to which the product will enter directly into the
environment,

(c) the possible excretion of the product,
its active substances or relevant metabolites into the environment by treated
animals; persistence in such excreta,

(d) the disposal of unused veterinary
medicinal product or other waste product.

In the second phase, further specific
investigation of the fate and effects of the product on particular ecosystems
shall be conducted, in accordance with established guidance. The extent of
exposure of the product to the environment, and the available information about
the physical/chemical, pharmacological and/or toxicological properties of the substance(s)
concerned, including metabolites, shall be taken into consideration.

1.3.2. DATA SET REQUIREMENTS FOR SAFETY

A. Safety tests

A.1. Precise identification of the product
and of its active substance(s)

A.2. Pharmacology

A.2.1  Pharmacodynamics

A.2.2. Pharmacokinetics

A.3. Toxicology

A.3.1. Single-dose toxicity

A.3.2. Repeat-dose toxicity

A.3.3. Tolerance in the target species

A.3.4. Reproductive toxicity including
developmental toxicity

A.3.4.1. Study of the effects on
reproduction

A.3.4.2. Study of developmental toxicity

A.3.5. Genotoxicity

A.3.6. Carcinogenicity

A.4. Other requirements

A.4.1. Microbiological properties of
residues (potential effects on the human gut flora, potential effects on the
microorganisms used for industrial food processing)

A.4.2. Observations in humans

A.4.3. Development of resistance

A.5. User safety

A.6. Environmental risk assessment

A.6.1. Environmental risk assessment of
veterinary medicinal products not containing or consisting of genetically
modified organisms

A.6.2. Environmental risk assessment for
veterinary medicinal products containing or consisting of genetically modified
organisms

B. Residue tests

B.1. Metabolism and residue kinetics

B.1.1. Pharmacokinetics (absorption,
distribution, metabolism, excretion)

B.1.2. Depletion of residues

B.2. Residue analytical method

1.4. EFFICACY DOCUMENTATION

1.4.1. BASIC PRINCIPLES AND REQUIREMENTS

The result of pre-clinical studies and
clinical trials shall be included.

The pharmacological activity and the
tolerance of the product shall be included through pre-clinical studies.

The clinical trials shall demonstrate or
substantiate the efficacy of the veterinary medicinal product at the dosage
regimen via the route of administration and specify its indications and contra-indications
according to species, age, breed and sex, its directions for use as well as any
adverse events which it may have.

Experimental data shall be confirmed by
data obtained under normal field conditions.

Clinical trials shall be carried out with
control animals (controlled clinical trials), unless it is justified to carry
out the clinical trials without control animals. The efficacy results obtained shall
be compared with those from the target animal species that have received a
veterinary medicinal product authorised in the Union for the same indications
for use in the same target animal species, or a placebo or no treatment. All
the results obtained, whether positive or negative, shall be reported.

Established statistical principles shall be
used in protocol design, analysis and evaluation of clinical trials, unless
justified.

All veterinary clinical trials shall be
conducted in accordance with a detailed trial protocol.

Clinical field trials shall be conducted in
accordance with established principles of good clinical practice and in
accordance with the principles of replacement, reduction and refinement of
animal testing.

Before the commencement of any field trial,
the informed consent of the owner of the animals to be used in the trial shall
be obtained and documented. In particular, the animal owner shall be informed
in writing of the consequences of participation in the trial for the subsequent
disposal of treated animals or for the taking of foodstuffs from treated animals.
A copy of this notification countersigned and dated by the animal owner shall
be included in the trial documentation.

Unless a blind field trial is conducted,
the provisions on the labelling of formulations intended for use in veterinary
field trials shall apply by analogy. In all cases, the words ‘for veterinary
field trial use only’ shall appear prominently and indelibly upon the
labelling.

1.4.2. DATA SET REQUIREMENTS FOR
EFFICACY

A.Pre-clinical requirements

A.1. Studies demonstrating pharmacological
activity;

A.2. Studies demonstrating the
pharmacodynamic mechanisms underlying the therapeutic effect;

A.3. Studies demonstrating the main
pharmacokinetic profile;

A.4. Studies demonstrating target animal
safety;

A.5. Studies investigating resistance.

Should unexpected results occur during the
course of the tests, those results shall be explained in detail.

B.  Clinical requirements

B.1. Composition of the product batches
used

B.2. Target species tolerance

B.3. Bibliographical information

PART 2 - Technical requirements for
biological veterinary medicinal products

2.1. INTRODUCTION

The technical documentation shall include a
detailed and full description of the studies conducted or referred to,
including the methods used. It shall be ensured that the data available are
relevant and are of sufficient quality to fulfil the requirements.

Data submitted shall be sufficient to
establish:

-  the dosage for the various animal
species for which the veterinary medicinal product is intended, its pharmaceutical
form, its method and route of administration and its proposed shelf life.

- the reasons for any precautionary and
safety measures to be taken when storing the veterinary medicinal product,
administering it to animals or disposing of waste, together with an indication
of potential risks that the veterinary medicinal product might pose to the
environment, to public and animal health;

- an indication of the withdrawal period in
the case of veterinary medicinal products intended for food-producing species.

- the therapeutic indications, contra-indications
and adverse events.

The application shall contain a description
of the testing methods employed by the manufacturer, the results of             pharmaceutical
(physico-chemical, biological or microbiological) tests and safety tests,
including tests assessing the potential risks posed by the medicinal product
for the environment. This impact shall be studied and consideration shall be
given on a case-by-case basis to specific provisions seeking to limit it. In addition,
results of residue tests, pre-clinical studies and clinical trials shall also
be submitted.

Pharmacological, toxicological, residue and
safety tests shall be carried out in conformity with the provisions related to
good laboratory practice (GLP) laid down in Directive 2004/10/EC and Directive
2004/9/EC.

Experiments on animals, except clinical
trials, shall be conducted in accordance with Directive 2010/63/EU.

The environmental risk assessment connected
with the release of veterinary medicinal products containing or consisting of
Genetically Modified Organisms (GMOs) within the meaning of Article 2 of
Directive 2001/18/EC shall be provided in the dossier. The information shall be
presented in accordance with the provisions of Directive 2001/18/EC.

The application shall, where necessary,
include information regarding pharmacovigilance system.

For applications submitted through the
centralised procedure, the formats made available by the Agency must be used
for the submission of the dossier.

2.2. QUALITY DOCUMENTATION

2.2.1. BASIC PRINCIPLES AND REQUIREMENTS

All analytical test procedures must be
described in sufficient details to enable the procedures to be repeated if
necessary (e.g. by an official laboratory). All procedures need to be validated
by the applicant and the results of the validation studies must be provided.

Applications for immunologicals shall
contain information on diluents needed for making the final vaccine
preparation.

An immunological veterinary medicinal
product shall be regarded as one product even when more than one diluent is
required so that different preparations of the final product can be prepared,
which may be for administration by different routes or methods of
administration. Diluents may be packed together with the vaccine vials or
separately.

2.2.2. DATA SET REQUIREMENTS FOR QUALITY

A. Qualitative and quantitative
composition

A.1. Qualitative particulars

A.2. Usual terminology

A.3. Quantitative particulars

A.4. Product development

A.5. Containers

B. Description of manufacturing method

C. Production and control of starting
materials

C.1. Starting materials listed in
pharmacopoeias

C.2. Starting materials not listed in a
pharmacopoeia

C.2.1. Starting materials of biological
origin

C.2.2. Starting materials of non-biological
origin

C.2.3. Specific measures concerning the
prevention of the transmission of animal spongiform encephalopathies

D. Control tests during the
manufacturing process

E. Control tests on the finished product

E.1. General characteristics of the
finished product

E.2. Identification of active substance(s)

E.3. Batch titre or potency

E.4. Identification and assay of adjuvants

E.5. Identification and assay of excipient
components

E.6. Safety tests

E.7. Sterility and purity test

E.8. Residual humidity

E.9. Inactivation

F. Batch to batch consistency

G. Stability tests

H. Other information concerning
genetically modified organisms

2.3. SAFETY DOCUMENTATION

2.3.1. BASIC PRINCIPLES AND REQUIREMENTS

The safety tests shall be carried out in
the target species.

The safety tests shall show the potential
risks from the biological veterinary medicinal product, which may occur under
the proposed conditions of use in animals. Those risks shall be evaluated in
relation to the potential benefits of the product. Certificates of compliance
with Good Laboratory Practice shall accompany relevant studies.

The safety documentation shall be used for
assessment of the potential risks which may result from the exposure of human
beings to the veterinary medicinal product, for example during its
administration to the animal.

Where immunological veterinary medicinal
products consist of live organisms, especially those which could be shed by
vaccinated animals, the potential risk to unvaccinated animals of the same or
of any other potentially exposed species shall be evaluated. In the case of
live vaccine strains which may be zoonotic, the risk to humans shall be
assessed.

The environmental risk assessment shall
evaluate the potential harmful effects, which the use of the product may cause
to the environment and identify any precautionary measures, which may be
necessary to reduce such risks.

This assessment shall normally be conducted
in two phases. The details of the assessment shall be provided in accordance
with established guidance. The first phase of the assessment shall always be
performed and shall indicate the potential exposure of the environment to the
product and the level of risk associated with any such exposure, taking into
account in particular the following items:

— the target animal species and the
proposed pattern of use,

— the method of administration, in
particular the likely extent to which the product will enter directly into the
environment,

— the possible excretion of the product,
its active substances into the environment by treated animals, persistence in
such excreta,

— the disposal of unused or waste product.

Where the conclusions of the first phase
indicate potential exposure of the environment to the product, the applicant shall
proceed to the second phase and evaluate the potential risk(s) that the
veterinary medicinal product might pose to the environment. Where necessary,
further investigations on the impact of the product on soil, water, air,
aquatic systems, non-target organisms shall be carried out.

2.3.2. DATA SET REQUIREMENTS FOR SAFETY

A. Pre-clinical studies

A.1. Safety of the administration of one
dose

A.2. Safety of one administration of an
overdose

A.3. Safety of the repeated administration
of one dose

A.4. Examination of reproductive
performance

A.5. Examination of immunological functions

A.6. Special requirements for live vaccines

A.6.1. Spread of the vaccine strain

A.6.2. Dissemination in the vaccinated
animal

A.6.3. Reversion to virulence of attenuated
vaccines

A.6.4. Biological properties of the vaccine
strain

A.6.5. Recombination or genomic
re-assortment of strains

A.7. User safety

A.8. Residue tests

A.9. Interactions with other veterinary
medicinal products

B. Clinical trials

C. Environmental risk assessment

D. Assessment required for veterinary
medicinal products containing or consisting of genetically modified organism

2.4. EFFICACY DOCUMENTATION

2.4.1. BASIC PRINCIPLES AND REQUIREMENTS

All efficacy studies shall be conducted in
accordance with a fully considered detailed protocol, which shall be recorded
in writing prior to commencement of the study. Pre-established systematic
written procedures for the organisation, conduct, data collection,
documentation and verification of efficacy trials shall be required.

All efficacy studies and trials shall be
described in sufficiently precise details so as to be reproducible in
controlled studies or trials, carried out at the request of the competent
authorities.

Efficacy studies carried out in the
laboratory shall be controlled trials, including untreated control animals
unless this is not justified for animal welfare reasons and efficacy can be
otherwise demonstrated. In general, these laboratory studies shall be supported
by trials carried out in field conditions, including untreated control animals.

2.4.2. DATA SET REQUIREMENTS FOR
EFFICACY

A. Pre-clinical studies

A.1. Quality data on the product batches
used

A.2. Description of the study

B. Clinical trials

B.1. Qualitative data on the product
batches used

B.2. Description of the trial

C. Bibliographical information

2.5. VACCINE ANTIGEN MASTER FILES

A Vaccine Antigen Master File means a
stand-alone part of the marketing authorisation application dossier for a
vaccine, which contains all relevant information on quality concerning each of
the active substances, which are part of this veterinary medicinal product. The
stand-alone part may be common to one or more monovalent and/or combined
vaccines presented by the same applicant or marketing authorisation holder.

2.6. MULTI-STRAIN DOSSIERS

For foot-and-mouth disease, avian influenza
and bluetongue vaccines a multi-strain dossier shall be submitted.

A multi-strain dossier means a single
dossier containing the relevant data for a unique and thorough scientific
assessment of the different options of strains or combinations of strains
permitting the authorisation of vaccines against antigenically variable
viruses.

PART 3 - Technical requirements for
homeopathic veterinary medicinal products

3.1. INTRODUCTION

The requirements as described in Part 1
shall apply to the homeopathic veterinary medicinal products referred to in
Article 88 with the following modifications.

3.2. QUALITY

3.2.1. TERMINOLOGY

The Latin name of the homeopathic stock
described in the marketing authorisation application dossier shall be in
accordance with the Latin title of the European Pharmacopoeia or, in absence
thereof, of an official pharmacopoeia of a Member State. Where relevant the
traditional name(s) used in each Member State shall be provided.

3.2.2. CONTROL OF STARTING MATERIALS

The particulars and documents on the
starting materials, i.e. all of the materials used from the first step of
production of the homeopathic stock through to the final dilution to be
incorporated into the finished homeopathic veterinary medicinal product,
accompanying the application shall be supplemented by additional data on the
homeopathic stock.

The general quality requirements shall
apply to all of the starting and raw materials as well as intermediate steps of
the manufacturing process up to the final dilution to be incorporated into the
finished homeopathic product. Where a toxic component is present, this shall be
controlled if possible in the final dilution. However, if this is not possible
because of the high dilution, the toxic component shall normally be controlled
at an earlier stage. Every step of the manufacturing process from the starting
materials up to the final dilution to be incorporated into the finished product
must be fully described.

In case dilutions are involved, these
dilution steps shall be done in accordance with the homeopathic manufacturing
methods laid down in the relevant monograph of the European Pharmacopoeia or,
in absence thereof, in an official pharmacopoeia of a Member State.

3.2.3. CONTROL TESTS ON THE FINISHED
MEDICINAL PRODUCT

Any exception to the general quality
requirements shall be duly justified by the applicant.

Identification and assay of all the
constituents that may have a toxicological effect shall be carried out. If it
can be justified that identification and/or an assay on all the toxicologically
relevant constituents is not possible e.g. due to their dilution in the
finished medicinal product the quality shall be demonstrated by complete
validation of the manufacturing and dilution process.

3.2.4. STABILITY TESTS

The stability of the finished product shall
be demonstrated. Stability data from the homeopathic stocks are generally
transferable to dilutions or potentisations obtained thereof. If no
identification or assay of the active substance is possible due to the degree
of dilution, stability data of the pharmaceutical form may be considered.

3.3. SAFETY

The requirements on safety set out in Part
1 shall apply to the registration of homeopathic veterinary medicinal products
referred to in Article 88, without prejudice to the provisions of Regulation
(EC) No 470/2009 for substances included in the homeopathic stocks intended for
administration to food-producing animal species.

Any missing information must be justified,
e.g. justification must be given why demonstration of an acceptable level of
safety can be supported although some studies are lacking.

ANNEX III

Requirements for abridged and reduced
dossiers for marketing authorisation applications

1. Generic veterinary medicinal products

Applications for generic veterinary
medicinal products shall contain the documentation referred to in Annex I,
quality data and data demonstrating that the product has the same qualitative
and quantitative composition in active substances and the same pharmaceutical
form as the reference medicinal product and data showing bio- equivalence with
the reference medicinal product.

All immediate-release oral pharmaceutical
forms shall be considered to be the same pharmaceutical form.

Every claim in the summary of product
characteristics not known from or inferred from the properties of the medicinal
product and/or its therapeutic group shall be discussed in the non-clinical or
clinical overviews and summaries and substantiated by published literature,
additional studies or both.

The following information shall be
submitted as part of an application:

— the grounds for claiming essential
similarity,

— a summary of impurities present in
batches of the active substance(s) as well as those of the finished medicinal
product (and where relevant decomposition products arising during storage) as
proposed for use in the product together with an evaluation of these
impurities,

— an evaluation of the bio-equivalence
studies or a justification as to why studies were not performed,

— if applicable, additional data in order
to demonstrate the equivalence of safety and efficacy properties of different
salts, esters or derivatives of an authorised active substance shall be
provided by the applicant; those data shall include evidence that there is no
change in the pharmacokinetics or pharmacodynamics of the therapeutic moiety
and/or in toxicity, which could influence the safety/efficacy profile.

For generic veterinary medicinal products
intended to be administered by intramuscular, subcutaneous or transdermal
routes, the following additional data shall be provided:

— evidence to demonstrate equivalent or
differing depletion of residues from the administration site, which may be
substantiated by appropriate residue depletion studies,

— evidence to demonstrate target animal
tolerance at the administration site, which may be substantiated by appropriate
target animal tolerance studies.

2. Similar biological veterinary
medicinal products

Where a biological veterinary medicinal
product which is similar to a reference biological veterinary medicinal product
does not meet the conditions in the definition of generic medicinal product,
information to be supplied shall not be limited to pharmaceutical, chemical and
biological data, supplemented with bio-equivalence and bioavailability data. In
such cases, additional data shall be provided, in particular on the safety and
efficacy of the product.

3. Bibliographic applications

For veterinary medicinal products the
active substance(s) of which has/have been in ‘well-established veterinary use’
as referred to in Article 20, with documented efficacy and an acceptable level
of safety, the following is required:

A. Information as listed in the Annex I.

B. Quality data.

C. Detailed scientific bibliography
addressing all aspects of the safety and efficacy.

D. Post-marketing experience with other
products containing the same constituents.

It
shall not be allowed to refer to scientific literature in accordance with
paragraph 1 if the application provides for a new indication of a substance in
well-established use.

Assessment
reports published by the Agency as an outcome of the evaluation of applications
for maximum residue limits in accordance with Regulation (EC) No 470/2009 may
be used as appropriate scientific literature referred to in paragraph 1, in
particular for the purpose of demonstrating the safety of the active substance.

4. Combination veterinary medicinal
products

Data as described in Annex II shall be
provided for the combination veterinary medicinal product. It shall not be
necessary to provide studies on the safety and efficacy of each active
substance. It shall nevertheless be possible to include information on the
individual substances in the application for a fixed combination.

The submission of data on each individual
active substance, in conjunction with the required user safety tests, residues
depletion studies and clinical studies on the fixed combination product, may be
considered a suitable justification for omitting data on the combination
product, based on animal welfare grounds and unnecessary testing on animals,
unless there is suspected interaction leading to added toxicity.

Where applicable, information regarding the
manufacturing sites and the safety evaluation of extraneous agents shall be
provided.

5. Informed consent applications

Applications based on Article 19 shall
contain the data described in Annex I, provided that the marketing authorisation
holder for the original veterinary medicinal product has given the applicant
his consent to refer to the safety and efficacy data dossier of that product.
In this case, there is no need to submit quality, safety and efficacy detailed
and critical summaries.

6. Documentation for applications in
exceptional circumstances

A marketing authorisation may be granted
subject to certain specific conditions and restrictions requiring the applicant
to introduce specific procedures, in particular concerning the safety and
efficacy of the veterinary medicinal product, when, as provided for in Article
22, the applicant can show that he is unable to provide comprehensive data on
the efficacy and safety under normal conditions of use.

ANNEX IV

CORRELATION TABLE

Directive 2001/82/EC

Directive 2001/82/EC || This Regulation

Article 1 || Article 4

Article 2(1) Article 2(2) Article 2(3) || Article 2(1) Article 3 Article 2(2),(3),(4)

Article 3 || Article 2(4)

Article 4(2) || Article 120

Article 5 || Article 5

Article 6 || Article 7(4)

Article 7 || Article 119

Article 8 || Article 119, 121

Article 9 || Article 8

Article 10 || Article 115

Article 11 || Articles 116, 117

Article 12 || Article 7

Article 13(1) Article 13(2),(3),(4) || Article 16  Article 18

Article 13a || Article 20

Article 13b || Article 17

Article 13c || Article 19

Article 14 || Article 30

Article 16 || Article 88

Article 17 || Article 89

Article 18 || Article 90

Article 19 || Article 88

Article 20 || Article 88

Article 21(1) Article 21(2) || Article 42(1) Article43

Article 22 || Article 45

Article 23 || Article 23, 24

Article 24 || Article 25

Article 25 || Article 28

Article 26(3) || Article 22

Article 27 || Article 55

Article 27a || Article 53

Article 27b || Article 58

Article 28 || Article 5(2)

Article 30 || Article 32

Article 31 ||  Article 142

Article 32 || Article 46, 48

Article 33 || Article 49

Article 35 || Article 84

Article 36 || Article 85

Article 37 || Article 86

Article 38 || Article 87

Article 39 || Article 58

Article 44 || Article 91

Article 45 || Article 92

Article 46 || Article 93

Article 47 || Article 93

Article 48 || Article 96

Article 50 || Article 98

Article 51 || Article 92

Article 52 || Article 100

Article 53 || Article 100

Article 55 || Article 100

Article 56 || Article 102

Article 58 || Article 9, 10

Article 59 || Article 11

Article 60 || Article 10(3)

Article 61 || Article 13

Article 65 || Article 104, 105

Article 66 || Article 107

Article 67 || Article 29

Article 68 || Article 109

Article 69 || Article 112

Article 70 || Article 114

Article 71 || Article 113

Article 72 || Article 74

Article 73 || Article 74

Article 74 || Article 78

Article 75 || Article 78

Article 76 || Article 75

Article 78(2) ||  Article 131

Article 80 || Article 125

Article 81 || Article 129

Article 83 || Article 132

Article 84 || Article 133

Article 85(3) || Article 123, 124

Article 87 || Article 79(2)

Article 88 || Article 7(7)

Article 95 || Article 8(2)

Article 95a || Article 122

[1]               Directive
2004/10/EC of the European Parliament and of the Council of 11 February 2004 on
the harmonisation of laws, regulations and administrative provisions relating
to the application of the principles of good laboratory practice and the
verification of their applications for tests on chemical substances  (OJ L 50,
20.2.2004, p. 44).

[2]               Directive
2004/9/EC of the European Parliament and of the Council of 11 February 2004 on
the inspection and verification of good laboratory practice (GLP) (OJ L 50,
20.2.2004, p. 28).

[3]           Directive
2009/35/EC of the European Parliament and of the Council of 23 April 2009 on
the colouring matters which may be added to medicinal products (OJ L 109,
30.4.2009, p. 10).

[4]           Commission Directive 2008/128/EC of 22 December 2008
laying down specific purity criteria concerning colours for use in foodstuffs
(OJ L 6, 10.1.2009, p. 20).