EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 10.9.2014  
COM(2014) 558 final 
2014/0257 (COD) 
  
Proposal for a 
REGULATION OF THE EUROPEAN PA RLIAMENT AND OF THE COUNCIL 
on veterinary medicinal products 
(Text with EEA relevance) 
{SWD(2014) 273 final} 
{SWD(2014) 274 final}  EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
Justification and objectives 
Work on a European legal framework for veteri nary medicinal products started in 1965 with 
the adoption of Directive 65/65/EEC,1 which required that marketi ng authorisations be issued 
before such products could be placed on the market. Since the n, numerous other directives 
and regulations have been adopted to exte nd and refine the ru les, 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, di stribution, pharmacovigilance and use of 
veterinary medicinal products over their life time. The annex to the Directive 2001/82/EC 
specifies the data to be submitted in applica tions for marketing authorisations. Among other 
things, the Regulation (EC) No  726/2004 lays down the EU pro cedures applying to medicinal 
products for human and veterinary use and esta blishes the European Medicines Agency (‘the 
Agency’). 
In the course of the co-decision procedure for its proposal for a regula tion on residue limits of 
pharmacological active substances in foodstu ffs, the Commission submitted a declaration4 
recognising the importance of problems linked to  the availability of veterinary medicinal 
products, the use of veterinary  medicinal products in speci es for which they are not 
authorised, and disproportionate regulat ory burden hampering innovation. The present 
proposal is the Commission’s follow-up to its declaration. 
Stakeholders and Member States have expresse d concern that the curr ent legislation does not 
fully deliver a single market in veterinary me dicinal 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 n eeds of the veterinary se ctor differ substantially 
from those of the human sector in relation to medicines. In particular, the drivers for 
investment for the human and the veterinary me dicines markets are different. For example, in 
the veterinary sector there are many different animal species, which creates both a fragmented 
                                                 
1 Council Directive 65/65/EEC of 26 January 1965 on the approx imation 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 pr oducts (OJ L 311, 28.11.2001, p. 1). 
3 Regulation (EC) No 726/2004 of the European Par liament and of the Council of 31 March 2004 laying down 
Community procedures for the authorisa tion and supervision of medicinal produc ts 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 po sition of the Council on the adoption of a proposal for a 
Regulation of the European Parliament and the Council la ying 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). EN 3   EN market and the need for major investments in or der 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 th an 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 framewor k addressing the characteristic s and specificities of the 
veterinary sector, which cannot be considered as a model fo r the human medicines market. 
 The revision of Directive 2001/ 82/EC and other legislation on veterinary medicinal products 
is in line with the principl es 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, pro portionate 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 i nnovation will provide 
new and better medicines to treat and prevent di seases in animals, while avoiding damage to 
the environment. 
The spread of AMR is a major threat to pub lic and animal health. In November 2011, the 
Commission launched a fi ve-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 medicina l products. This proposal implements this 
action. 
The Commission’s Communication on honeybee health6 stresses the importance of 
proactively protecting bee health, while taking into account the particularities of beekeeping, 
and acknowledges the limited availability of medici nes to treat the diseases that afflict bees. 
As regards measures to increase availability, the Communication refers to the revision of the 
legislation on veterina ry medicinal products. 
Legal basis 
The legal bases for legislative measures on animal health, which are essential to public and 
animal health, environmental protecti on, 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 functi oning of the internal market and the 
approximation of relevant legal, regula tory and administrative provisions; and 
–  Article 168(4)(b) TFEU, whic h covers measures in the veterinary field directly 
aimed at protecting public health. 
                                                 
5 Communication from the Commission to the Eu ropean Parliament and the Council on an Action Plan against the rising 
threats of antimic robial resistance  (COM 2011/748, 15.11.2011). 
6 Commission Communication on honeybee health  (COM 2010/714, 6.12.2010). EN 4   EN 2. RESULTS  OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENTS 
Better regulation of veterinary pharmaceutical s: how to put in place a simpler legal 
framework, safeguarding public and animal hea lth while increasing th e 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 — ge neral 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 su mmary of product characteristics (SPC) included in the terms of 
the marketing authorisation. Those terms also c ontain 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 pharmacol ogically active substance it contains. 
An applicant has to provide certain details on the packaging and labell ing of the medicine. 
The proposal introduces a major simplificatio n of the rules by redu cing the compulsory 
information and introducing harmonised pictog rams and abbreviations. This should reduce 
translation and packaging costs and encourage multilingual packages and labelling. Member 
States will have a degree of flex ibility 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 au thorisation may be granted w ithout 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 medici nal product, the applicant is not required to 
prove safety and efficacy and the application w ill rely on the data pr ovided 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 author isation. It addresses the characteristics and 
specificities of the veterinary sector. Experience has shown that  the needs of the veterinary 
                                                 
7 For a summary of the responses, see: http://ec.europa.eu/he alth/files/veterinar y/vet_pubcons_rep2011.pdf . 
8 Study carried out by GHK Consulting, a member of the Eu ropean Policy Evaluation Consortium (EPEC), assisted by 
Triveritas. EN 5   EN sector differ substantially from those of the human sector. Also the drivers for investment 
differ for the human and veterina ry medicines market, for example in animal health there is 
more than one species, creating a fragmented ma rket and necessitating major investments to 
add other animal species. Therefore, the provi sions in this proposal to stimulate innovation 
cannot be considered as a model for th e human medicines market. The protection 
arrangements prevent applican ts 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 fo r in Directive 2001/82/EC should create 
incentives and stimulate innovation in the animal health sector. The curre nt ten-year period 
would be maintained for the initial marketing au thorisation. In order to  encourage industry to 
extend already authorised products to other spec ies, a further 1 year would be added for any 
extension of the veterinary me dicinal products to another sp ecies (up to a maximum of 18 
years).  
In order to encourage the an imal health industry to deve lop 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 applicati on for an extension must be submitted at least 3 
years before expiry of the data protection pe riod. This ensures that companies can place a 
generic product on the market immediately afte r expiry of the protection period for the 
reference product. Product developments for bee medicines will re ceive 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 protec tion 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 procedur e for the authorisation of  clinical trials is 
provided for (this is cu rrently 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 an timicrobials in the veterinary 
sector. 
Chapter III:  Procedures for gran ting marketing authorisations 
Various marketing authorisation procedures are provided for: 
• a centralised procedure, in which the Commission grants an  authorisation; 
• procedures in which Member St ates 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 asse ssment 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 medicina l product. For products EN 6   EN that are of interest in the majority of the Me mber States, access to the centralised procedure 
can lead to savings for the ma rketing authorisation holder.  
The mutual recognition  procedure applies for veterina ry medicinal products already 
authorised in one Member State for which authoris ation is requested in re spect 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 aut horisation has been granted for the group of 
Member States in the original  application, marketing authoris ation holders can obtain an 
authorisation for additional Memb er 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 authoris ations to other Member States and therefore 
increase the availability of veteri nary medicinal products in the Union. 
For the decentralised and mutual recognition pro cedures, 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 sc ientific opinion to th e 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 veteri nary 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 ve terinarians will be able to 
identify the products they need  from other Member States. 
Post-marketing authorisation measures incl ude amending marketing authorisations and 
monitoring products after they have been on th e 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 (E C) No 1234/2008 should no longer apply to 
variations to veterina ry medicinal products. The Regulati on lays down a system for varying 
the terms of marketing authorisat ions 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 unint ended effects when actually brought into use. 
Pharmacovigilance involves iden tifying adverse events and determining what action, if any, is 
required. The objective is to en sure the continuous safety of products once they are 
authorised. This proposal intr oduces a risk-based approach to pharmacovigilance whereby 
certain requirements that do not contribute e ffectively to public health, animal health or 
environmental protection (e.g. submitting periodi c safety update reports) are relaxed. The 
Agency will manage a database of adverse ev ents linked to medicines authorised in the 
Union. It will work together with  competent authorities to mon itor and evaluate collated data 
on adverse events linked to similar groups of veterinary medicinal products (signal 
management process). EN 7   EN Many SPCs of nationally authorised products ma y 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 s eeks 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 subj ect to an administrative procedure; and  
• products that are by nature more likely to pres ent a risk to animal or public health or 
the environment will be scientifically re-assessed.  
This harmonisation should increase the av ailability of products in the Union. 
Member States or the Commission can reques t 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 Co mmission adopts a decision that will apply 
throughout the Union.  
In addition, a system will be se t up to record and report the use of antimicrobials. This is one 
of measures in the Commission’s AMR action plan. 
Chapter V: Homeopathic vet erinary medicinal products 
This part lays down requireme nts and a simplified registratio n procedure for homeopathic 
veterinary medicinal products. 
Chapter VI: Manufacturing, import and export 
This part covers the procedure and require ments for obtaining an authorisation to 
manufacture, import or export veterinary medicina l products. It lays dow n the obligations of a 
manufacturing authorisation holder. These ru les 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 vete rinary medicinal products after a marketing 
authorisation has been granted. It imposes ne w 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 medi cinal products in the Un ion, retailers should be 
allowed to sell products via the in ternet if they are authorised to supply them in the Member 
State in which the buyer is established. On line sales of veterina ry 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 reason s, on supplying veterinary medicinal products 
to the public via the internet. 
The provisions on the use of veterinary medicina l 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 availabl e treatment for animals under their care; 
• withdrawal periods are determined accordi ng to a multiplication factor system which 
takes account of relevant available information; EN 8   EN • specific provisions are include d for the use of products in an aquatic environment in 
order to better protect the environment; and 
• the Commission is empowered to exclude or re strict the use of certain antimicrobials. 
Chapter VIII: Controls 
Inspections by Member States’ competent authorit ies should ensure that the Union rules are 
complied with and enforced at national level. The Agency should coordi nate the controls of 
veterinary medicinal products au thorised by the centralised proce dure. The key change is that 
the Commission will be able to check Member States’ inspection systems to ensure that the 
legislation is enforced consiste ntly. 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 varyin g marketing authorisations; or 
• prohibiting the supply of vete rinary 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 networ k between the competent authorities of the 
Member States, the Agency and th e Commission should ensure that: 
• veterinary medicinal products ar e 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 func tioning and the tasks of the Agency’s Committee 
for Medicinal Products for Veterinary Use (C VMP) and the Coordination Group for Mutual 
Recognition and Decentralised Procedures (vet erinary) (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 majo rity 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 repla ces Directive 2001/82/EC. To gi ve 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 f act that centralised 
marketing authorisation for veterinary medicina l products is being decoupled from that for 
medicines for humans. The amendments are pr oposed in a separate act accompanying this 
proposal. EN 9   EN 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 ha ve any financial impact on the budget of the EU. 
As set out in the legislative financial statemen t the additional resource needs for the European 
Medicines Agency are approximate ly 8 staff plus expenditure for meetings, translation, IT, 
etc.  
The level of fees, their structure, modalities an d exceptions will be set at a later stage by the 
Commission by way of implementing acts. This hol ds 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 
 EN 10   EN 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 CO UNCIL 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 Eu ropean Economic and Social Committee
9, 
Having regard to the opinion of  the Committee of the Regions10, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) Directive 2001/82/EC of the Eur opean Parliament and of the Council
11 and Regulation 
(EC) No 726/2004 of the European Parliament and of the Council12 constitute the 
Union regulatory framework for the placing on the market, manufacture, import, export, supply, pharmacovigilance, contro l and the use of veterinary medicinal 
products.  
(2) In the light of the experience acqui red and following the assessment by the 
Commission of the functioning of the mark et for veterinary medicinal products, the 
legal framework for veterinary medicinal pr oducts should be ad apted to scientific 
progress, the current market c onditions 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 ma jor policy objectives set out in the 
Communication from the Commission of 3 March 2010 "Europe 2020 A Strategy for 
smart, sustainable a nd inclusive growth"
13. 
(4) Experience has shown that the needs of th e 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 veterina ry medicines markets are different. For 
                                                 
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. EN 11   EN 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 th e 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 fr action of the size of the pharmaceutical 
industry for human medicines.It is theref ore appropriate to de velop a regulatory 
framework addressing the characteristics and specificities of the veterinary sector, 
which cannot be considered as a mode l 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, anim al 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 hi gh standards of animal and public 
health, and for the development of the ag riculture and aquaculture sectors.   
(7) This Regulation should set high standards of  quality, safety and efficacy for veterinary 
medicinal products in order to meet comm on concerns as regards the protection of 
public and animal health. At the same time , this Regulation shoul d harmonise the rules 
for the authorisation of veterinary medici nal 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 pr oducts that ensure the same conditions for 
all applications and a transparent fra mework for all interested parties. 
(9) The scope of the mandatory use of a cen tralised authorisatio n procedure under which 
the authorisations are valid th roughout 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 Uni on, the centralised aut horisation procedure 
should be extended to allow for applications for authorisations unde r that procedure to 
be submitted for any veterinary medicinal product, including for generics of nationally authorised veterinary medicinal products.  
(10) The national procedure for authorisi ng veterinary medicinal products should be 
maintained because of varying needs in di fferent geographical areas of the Union as 
well as the business models of small and medi um sized enterprises (SMEs).  It should 
be ensured that marketing authorisations gr anted in one Member State are recognised 
in other Member States.  
(11) In order to help applicants, and in partic ular SMEs, to comply with the requirements of 
this Regulation, Member States should provi de advice to the applicants, for example 
by establishing helpdesks. This advice should be provided in addition to the EN 12   EN operational guidance documents and other advice and assistance provided by the 
European Medicines Agency. 
(12) In order to avoid unnecessary administrati ve 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 mutu al recognition procedure to 
resolve any disagreements between competen t 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 pres ent a potential serious risk to human or 
animal health or to the environment, a sc ientific evalua tion of the product should be 
undertaken at Union level, leading to a single decision on the ar ea of disagreement, 
binding on the Member States concerned, be ing 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 phar macologically active 
substances which the product contains ar e 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, ve terinarians should be 
allowed to prescribe other medicinal products  to the animals under their responsibility 
in conformity with strict rules and in the in terest of animal health or animal welfare 
only. In case of food-producing animals,  veterinarians should ensure that an 
appropriate withdrawal peri od is prescribed, so that harmful residues of those 
medicinal products do not enter the food chain. 
(18) Member States should be able to a llow exceptional use of veterinary medicinal 
products without a marketing authorisation where it is necessary to respond to Union 
listed diseases and where the health situ ation in a Member State so requires. 
(19) Taking into account the need for si mple 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 scie ntific assessment. 
(20) Directive 2010/63/EU of the Eur opean Parliament and of the Council15 lays down 
provisions on the protection of animals used  for scientific purposes based on the 
principles of replacement, reduction and re finement. Clinical trials for veterinary 
medicinal products are exempted from that Directive. The design and performance of 
                                                 
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). EN 13   EN 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 shoul d 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, reductio n and refinement concer ning 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 observati ons. Regulation (EC) No 1049/2001 of the 
European Parliament and of the Council16 gives the fullest possibl e effect to the right 
of public access to documents and lays down the general principles and limits on such 
access. The European Medicines Agency s hould 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 pr otection 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 devel oping veterinary medicinal products for markets 
of a limited size. In order to promote the av ailability of veterinary medicinal products 
within the Union for those markets, in some cases it should be possible to grant marketing authorisations without a comp lete 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, th is 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 infreque ntly or in limited geographical areas.  
(24) Environmental risk assessments should be  mandatory for all new applications for a 
marketing authorisation and s hould consist of two phases. In the first phase the extent 
of environmental exposure of the product, its active substa nces 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 clini cal trials represent a major investment for 
companies which they need to make in or der 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 vete rinary medicinal product. That investment 
should be protected in order to stimulate re search and innovation, so that it is ensured 
the necessary veterinary medi cinal 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 prot ection should, however, be lim ited 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 
                                                
 
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). EN 14   EN medicinal product is a generic medicinal pr oduct of a veterinary  medicinal product 
that is authorised or has b een authorised in the Union.  
(27) It is recognised that the potential eff ect 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 applic ation 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 orde r to safeguard the e nvironment. In such 
cases applicants should endea vour to join efforts in generating such data in order to 
reduce costs and to reduce tes ting on vertebrate animals. 
(28) The protection of techni cal 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 auth orisation, for example in the 
case of extending use of an existing product to an additional animal species. In this case the variation or marketi ng 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 manuf acturing process of biological pr oducts or a change in the 
excipient used may lead to differences in the generic product ch aracteristics. In an 
application for generic biological veterina ry medicinal product the bioequivalence 
should be demonstrated in order to ensu re, based on the existing knowledge, that 
quality, safety and efficacy are similar. 
(30) In order to avoid unnecessary admini strative and financial burdens both for the 
competent authorities and for the pharm aceutical 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 excep tionally and should be duly justified.   
(31) It is recognised that, in some cases, a scientific risk assessm ent alone cannot provide 
all the information on which a risk manage ment decision should be based, and other 
relevant factors should be taken into acc ount including societal, economical, ethical, 
environmental and welfare factors and the feasibility of controls. 
(32) In certain circumstances wh ere a significant animal or public health concern exists but 
scientific uncertainty pers ists, appropriate measures can be adopted taking into 
account Article 5(7) of the WTO Agreemen t on the Application of Sanitary and 
Phytosanitary Measures which has been  interpreted for the Union in the 
Communication from the Commissi on on the precautionary principle
17.  In such 
circumstances, Member States or the Co mmission should seek to obtain additional 
information necessary for a more objective assessment of the particular concern and 
should review the measure accordingly w ithin a reasonable period of time.  
(33) Antimicrobial resistance to human and veterinary medicinal products is a growing 
health problem in the Union and worldwid e. Many of the antimicrobials used in 
animals are also used in humans. Some of those antimicrobials are critical for preventing or treating life-th reatening 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 ar e included on the labels of veterinary 
                                                
 
17 Communication from the Commission on the precautionary principle, COM (2000) 1 (final). EN 15   EN 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 advertis ing veterinary antimicrobials should be 
tightened, and the authorisati on 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. Therefor e, an application for an antimicrobial 
veterinary medicinal product should contain information about the potential risks that 
use of the product may lead to the developm ent 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 an timicrobials should only be authorised 
following a careful scientific benefit-risk a ssessment.  If necessary, conditions should 
be laid down in the marketing authorisation in  order to restrict th e 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 au thorisation, 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 de velopment of antimicrobial resistance. 
Combinations of antimicrobial substances should therefore only be  authorised where 
evidence is provided that the benefit-risk ba lance of the combination is favourable.   
(36) The development of new antimicrobials has not kept pace with the increase of 
resistance to existing antimicrobials. Gi ven 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 antimicr obials 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 reco mmendations of the Agency, should not be available on 
the market in the veterinary sector.  
(38) If an antimicrobial is ad ministered and used incorrectly, this presents a risk to public 
or animal health. Therefore antimicrobial  veterinary medicinal products should only 
be available on veterinary pr escription. Persons having the right to prescribe have a 
key role in ensuring prudent use of antimicrobials and cons equently they should not be 
influenced, directly or indirectly, by economic incentives when prescribing those 
products. Therefore the supply of veteri nary 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 inte rnational dimension of the development of 
antimicrobial resistance when assessing the be nefit-risk balance of certain veterinary 
antimicrobials in the Union. Any measure re stricting the use of those products may 
affect the trade of products of  animal origin or the compe titiveness 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 contac t with animals or EN 16   EN humans in third countries or by other means. Therefore, meas ures restricting the use of 
veterinary antimicrobials in the Union shoul d be based on scientific advice and should 
be considered in the context of cooperati on with third countries  and international 
organisations addressing antimicrobial resist ance in order the ensure consistency with 
their activities and policies. 
(40) There is still a lack of sufficiently deta iled and comparable data at Union level to 
determine the trends and identify possibl e risk factors that could lead to the 
development of measures to limit the risk fr om 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 anim als, data on the use of antimicrobials in 
humans and data on antimicrobial resistant organisms found in an imals, humans and 
food. To ensure that the information collect ed can be used eff ectively, appropriate 
rules should be laid down concerning the collection and the exchange of data. The 
Member States should be responsible for co llecting data on the use of antimicrobials 
under the coordination of the Agency. 
(41) The majority of the veterinary medicina l products on the market have been authorised 
under national procedures. The lack of harmonisati on of summary of product 
characteristics for veterinary medicinal pr oducts authorised nationally in more than 
one Member State creates additional and unne cessary barriers for the circulation of 
veterinary medicinal products within the Union. It is ne cessary to harmonise those 
summaries of product characteristics. In or der to avoid unnecessary costs and burdens 
for the Member States, the Commission and the pharmaceutical indus try, 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 anim al health and to the environment. This 
harmonisation exercise should cover veterina ry 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, si mplified 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 sta ndardised 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 em powered to choose the language of the text 
used in the packaging and labelling of ve terinary 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 me dicinal products in the Union it 
should be possible to grant more than one  marketing authorisation for a specific 
veterinary medicinal product to the same ma rketing authorisation holder in the same 
Member State. In that case all product-relat ed 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 
                                                
 
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). EN 17   EN 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 fo r the protection of public and animal health 
and the environment. Collection of informa tion on adverse events should contribute to 
the good usage of veterinary medicinal products.  
(46) In the light of the experience acquired it ha s 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 fo r 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 ha rmonisation of definitions, terminology and 
technological developments in th e field of pharmacovigilance.  
(47) Holders of marketing authorisations s hould be responsible for continuously carrying 
out pharmacovigilance of the veterinary medi cinal products they place on the market. 
They should collect reports on  adverse events relating to  their product s, 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 pharmacovigila nce system. Data collected should be 
uploaded to a single reporting point to ensu re that the information is shared. The 
competent authorities should use those data  to ensure the continuous safety and 
efficacy of the veterinary medicina l 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 av ailable at the time of  authorisation with 
additional information following the placin g of the product on the market. Therefore 
the obligation to conduct post-authorisa tion studies should be imposed on the 
marketing authorisation holder. 
(50) A pharmacovigilance databa se 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 dete ction 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 dist ribution of veterinary 
medicinal products, from manufacture or im port into the Union through supply to the 
end-user. Veterinary medicinal products fr om 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 Stat e being repeated in others, minimum 
requirements should be applied to veterina ry medicinal products manufactured in or 
imported from third countries.  
(53) The quality of veterinary medicinal pr oducts 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 posse ssion of an authoris ation to be able to  wholesale or retail 
veterinary medicinal products, so as to guara ntee that such medicines are appropriately EN 18   EN stored, transported and handled. It should be the responsibilit y of the Member States to 
ensure that those conditions are met. Thos e authorisations should be valid throughout 
the Union. 
(55) In order to ensure transparency, a databa se should be established at Union level for the 
purposes of publishing a list of wholesale di stributors 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. Vete rinary medicinal pr oducts 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, retail ers that are authorised to supply veterinary medicinal 
products by the competent aut hority in the Member State where they are established 
should be allowed to sell prescription and non-prescription ve terinary medicinal 
products via the Internet to buye rs in other Member States.  
(57) The illegal sale of vete rinary medicinal products to th e public via the Internet may 
represent a threat to public and animal h ealth, as falsified or substandard medicines 
may reach the public in this way. It is nece ssary to address this threat. Account should 
be taken of the fact that specific conditi ons 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 produc ts to the public wi thin the limits of 
the Treaty. 
(58) When examining the compa tibility with Union law of th e 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 distingu ish them substantially from other goods. 
The Court of Justice has also held that h ealth and life of huma ns rank foremost among 
the assets and interests protected by the Trea ty 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 achie ved. Since that level may vary from one 
Member State to another, Member States mu st be allowed some discretion as regards 
the conditions for the supply on their territory of medici nal 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 veterina ry medicinal products 
offered for sale at a distance, the public should be assisted in identifying websites 
which are legally offering such medici nal products. A common logo should be 
established, which is recognisable th roughout the Union, while allowing for the 
identification of the Member State where the person offering veterinary medicinal 
products for sale at a dist ance is established. The Comm ission should develop the 
design for such a logo. Websites offering vete rinary 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 author ities 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 orde r to provide comprehensive information to 
the public. EN 19   EN (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 n on-prescription medicinal produc ts, could affect public and 
animal health and distort competition. Therefore, advertising of veterinary medicinal products should satisfy certain criteria. Persons qualifi ed 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 apprec iate 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 a nd for the medicinal pr oduct to be dispensed 
in another Member State. The removal of regulatory and administrative barriers to 
such recognition should not affect any pr ofessional 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 pr escription, 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 Me mber States from being recognised.  
(64) Information on veterinary medicinal products  is essential in order to enable health 
professionals, authorities and undertakings to make inform ed decisions. A key aspect 
is the creation of a European database th at should collate information on marketing 
authorisations granted in  the Union. The database  should enhance overall 
transparency, streamline and facilitate the fl ow of information between authorities and 
prevent multiple reporting requirements. 
(65) The verification of compliance with th e legal requirements through controls is of 
fundamental importance to ensure that the ob jectives of the Regul ation 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 medicina l 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 es tablished by the competent authorities having 
regard to the risk and to the level of comp liance expected in the different situations. 
This approach should allow authorities to allocate resources wh ere the risk is the 
highest. In some cases, however, controls s hould be performed irre spective of the level 
of risk or expected non-compliance, fo r example prior to gr anting manufacturing 
authorisations. 
(67) In certain cases failures in Member Stat es’ control system can substantially hinder the 
achievement of the objectives of this Regul ation and may lead to the emergence of 
risks to public and animal health and the environment. To ensure a harmonised EN 20   EN approach to inspections throughout the Uni on, the Commission should be able to carry 
out audits in the Member States to verify the functioning of nationa l control systems.  
(68) In order to ensure transparency, impa rtiality 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 act s 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 impos ition of fines to the holders of marketing 
authorisations granted unde r this Regulation, the maximu m 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, f eed additives, biocidal products and other 
products. In order to avoid inconsistencies in the treat ment of such products, to 
increase legal certainty, and to facilitat e the decision proce ss 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 medi cinal product. In order to ensure legal 
certainty the Commission may decide whet her a specific product is a veterinary 
medicinal product. 
(71) Having regard to the special character istics of homeopathic veterinary medicinal 
products, especially the const ituents 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 therap eutic indications. Immunological homeopathic products 
cannot follow the simplified registration pr ocedure as immunologi cals may initiate a 
response at a high dilution rate. The quality aspect of a homeopath ic medicinal product 
is independent of its use so no specific pr ovisions should apply with regard to the 
necessary quality requirements and rules. 
(72) In order to follow the scie ntific developments of the sect or, the power to adopt acts in 
accordance with Article 290 of the Treaty s hould be delegated to the Commission in 
respect of amending the rules on designati on of homeopathic veterinary medicinal 
products for which registration procedure should be allowed. 
(73) In order to protec t public health, animal health and the environm ent, the activities and 
tasks attributed to the Agen cy in this Regulation should be adequately funded. Those 
activities, services and tasks should be f unded 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 th is Regulation are adapte d 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 th e scientific developments of the sector, the 
power to adopt acts in accordance with Ar ticle 290 of the Treat y should be delegated 
to the Commission in respect of the use of  a product outside the terms of the granted 
marketing authorisation, in particular rega rding establishing a list of antimicrobial 
veterinary medicinal products for which such use should be prohibited. EN 21   EN (76) In order to adapt this Regulation to th e scientific developments of the sector, the 
power to adopt acts in accordance with Ar ticle 290 of the Treat y should be delegated 
to the Commission in respect of amending the list of groups of veterinary medicinal products for which the centralised author isation procedure shall be compulsory. 
(77) In order to adapt this Regulation to th e scientific developments of the sector, the 
power to adopt acts in accordance with Ar ticle 290 of the Treat y should be delegated 
to the Commission in respect of establishi ng detailed rules on the principles for the 
refusal or restriction of mark eting authorisations of antimic robial veterinary medicinal 
products, in particular with a view to pr eserving 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 s hould be delegated to the Commission in 
respect of laying down the procedure for investigating the infringements and the 
imposition of fines or periodic penalty pa yments to the holders of marketing 
authorisations granted unde r this Regulation, the maximu m amounts of these penalties 
as well as the conditions and methods for their collection. 
(79) In order to introduce harmonised standa rds 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 Regula tion (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 th e existing rules, and 
aiming to improve the functioning of th e internal market, a regulation is the 
appropriate legal instrument to replace Directive 2001/82/EC in order to lay down 
clear, detailed and directly a pplicable 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 Regulati on, 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 th e internal market, cannot be sufficiently 
achieved by the Member States, but can rath er, 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 Ar ticle 5 of the Treaty on European Union. In 
accordance with the principle of proportional ity, as set out in that Article, this 
Regulation does not go beyond what  is necessary in order to  achieve those objectives, 
                                                 
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 concerni ng mechanisms for contro l by Member States of 
the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). EN 22   EN HAVE ADOPTED THIS REGULATION: 
Chapter I  
Subject matter, scope and definitions 
Article 1 
Subject matter 
This Regulation lays down rules for the plac ing on the market, manufacture, import, export, 
supply, pharmacovigilance, control and us e of veterinary medicinal products. 
Article 2 
Scope  
1. This Regulation shall apply to veterinary medicinal products prepared industrially or 
by a method involving an indus trial 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 us ed 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-inf ectious, anti-parasitic, anti-inflammatory, 
hormonal or psychotropic properties a nd 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 intende d 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 antigen s 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 produc ts containing autologous or  allogeneic cells or 
tissues that have not been subj ected to an industrial process; 
(c) veterinary medicinal products based on radio-active isotopes; 
(d) feed additives as defined in  Regul ation (EC) No 1831/2003 of the European 
Parliament and of the Council
20;  
(e) veterinary medicinal products intend ed for research and development. 
                                                 
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). EN 23   EN 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 
Council21 or Regulation (EC) No 1831/2003 of th e European Parliament and of the 
Council, and there is a conf lict 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 implemen ting 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 referre d 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 fo r treating or preventing disease in 
animals;  
(b) its purpose is to be used in or administer ed 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 produc t’ 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 char acterisation and the determination of its 
quality a combination of physico-chemi cal-biological testing, together with 
knowledge of the production process and its control; 
(6) ‘generic veterinary medici nal product’ means a veterina ry medicinal product which 
has the same qualitative and quantitative co mposition of active substances and the 
                                                
 
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). EN 24   EN same pharmaceutical form as the reference medicinal product, and with regard to 
which appropriate bioavailability studies ha ve demonstrated a bi oequivalence with 
the reference veterina ry medicinal product;  
(7) ‘homeopathic veterinary medicinal produc t’ means a veterinary medicinal product 
prepared from homeopathic stocks in accordance with a homeopathic manufacturing 
procedure described by the European Phar macopoeia 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 mi croorganisms 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 authorisat ion 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 aut horisation 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 a nd 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 developm ent 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 subs tances 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 aut hority 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 wh ich is placed the immediate packaging; 
(17) ‘immediate packaging’ means the container or  any other form of packaging that is in 
direct contact with the vete rinary medicinal product;  
(18) ‘package leaflet’ means a documentation l eaflet on a veterinary medicinal product 
which contains information to ensure its safe and efficacious use; 
(19) ‘letter of access’ means an original docum ent, signed by the data owner or its 
representative, which states that the data ma y 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: EN 25   EN (a) veterinary medicinal products for the trea tment 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 marke ting authorisation holde r with respect to 
one or more authorised veterinary medicinal products;  
(23) ‘control’ means any task pe rformed by a competent authority, including inspections, 
for the verification of compliance with this Regulation; 
(24) ‘veterinary prescription‘ means  any pres cription 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 peri od 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, consum ption or use on the Union ma rket in the course of a 
commercial activity, whether in return  for payment or free of charge; 
(27) ‘placing on the market’ means the first maki ng available of a veterinary medicinal 
product on the Union market. 
Chapter II  
Marketing authorisations – gen eral provisions and rules on 
applications 
SECTION 1  
GENERAL PROVISIONS  
Article 5 
Marketing authorisations 
1. A veterinary medicinal product shall be pl aced on the market only when a marketing 
authorisation has been grante d 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 sh all 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 a nd marketing authorisa tion holders shall be 
established in the Union.  EN 26   EN Article 6 
Submission of applications for marketing authorisations  
1. Applications shall be submitted to the co mpetent 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 marketi ng authorisations in accordance with the 
centralised marketing authorisation procedur e 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 electr onically. For applications submitted in 
accordance with the centralised marketing au thorisation 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 applica tion, 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 Ag ency 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 authorisa tion shall contain the following information: 
(a) the administrative information set out in Annex I; 
(b) technical documentation satisfying th e requirements set out in Annex II; 
(c) the information to be pr ovided in the immediate p ackaging, outer packaging 
and the package leaflet in accordance with Articles 9 to 14. 
2. Where the application concerns an antimic robial veterinary medicinal product, the 
following shall be submitted in addition to  the information listed in paragraph 1: 
(a) documentation on the direct or indirect ri sks to public or animal health of use 
of the antimicrobial veterinary medicinal product in animals,  
(b) information about risk mitigation measur es to limit antimicrobial resistance 
development related to the use of  veterinary medicinal product. 
3. Where the application concerns a veteri nary medicinal product intended for food-
producing target species and containing pharmacologically ac tive substances that are 
not listed in Table 1 of the Annex to Regulation (EU) No 37/2010 for the animal EN 27   EN species in question, a doc ument 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 declar ed as not being intended for slaughter for 
human consumption in accordance w ith Commission Regulation (EC) 504/200823 
and the active substances contained in t hose veterinary medici nal products are not 
listed in Table 2 of the Annex to Regulation (EU) No 37/2010. 
5. Where the application concerns a vete rinary medicinal pr oduct containing or 
consisting of genetically modified organi sms within the meaning of Article 2 of 
Directive 2001/18/EC of the Europ ean Parliament and of the Council24 the 
application shall in addition to the docume nts listed in paragra ph 1 be accompanied 
by: 
(a) a copy of the written consent of the comp etent authorities to the deliberate 
release into the environment of the gene tically modified orga nisms for research 
and development purposes, as provided fo r in Part B of Directive 2001/18/EC; 
(b) the complete technical file supplyin g 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 Direct ive 2001/18/EC; and 
(d) the results of any investigations perf ormed 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 declaratio n 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 a dopt delegated acts in accordance with 
Article 146 in order to amend Annexes I and II to adapt the information and documentation requirements to tech nical and scientific progress. 
                                                
 
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). EN 28   EN 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 th e 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 ente r the human food chain unless: 
(a) the tested product is a veterinary me dicinal product authorised for the food-
producing species used in the clinical tria l, and the withdrawal period set out in 
the summary of the product char acteristics is respected, or 
(b) the tested product is an authorised ve terinary medicinal product for target 
species other than the food-producing species  used in the clin ical trial and the 
withdrawal period set out in accord ance with Article 117 is respected. 
3. The competent authority shall issue a deci sion on the approval of a clinical trial 
within 60 days after the recei pt of an application. Wher e the competent authority has 
not notified the applicant of its decision with in that time limit, the clinical trial shall 
be considered to have been approved.  
4. The clinical trials referred to in paragra ph 1 shall be carried out taking due account of 
the standards set by the in ternational guidelin es on good clinical practice of the 
International Cooperation on Harmonisa tion of Technical Requirements for 
Registration of Veterina ry Medicinal Products. 
5. Results of clinical trials shall be submitted with the application for a marketing 
authorisation for the purposes of providi ng the documentation referred to in Article 
7(1)(b).  
6. Data stemming from clinical trials conduc ted outside the Union may be taken into 
consideration for the assessment of an app lication for a marketing authorisation only 
if those trials were designed, implemente d and reported in accordance with the 
standards set by the international guide lines on good clinical practice of the 
International Cooperation on Harmonisa tion of Technical Requirements for 
Registration of Veterina ry Medicinal Products. 
SECTION 4  
LABELLING AND PACKAGE LEAFLET  
Article 9 
Labelling of the immediat e packaging of veterinary medicinal products 
1. The immediate packaging of  a veterinary medicinal pr oduct 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 e xpressed qualitativel y and quantitatively 
per unit or according to the form of ad ministration for a particular volume or 
weight, using their common names; EN 29   EN (c) the batch number, preceded by the word "Lot"; 
(d) the name or corporate name or logo name of the marke ting 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 shal l appear in easily legible and clearly 
comprehensible characters, or, where appr opriate, abbreviati ons 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 sha ll 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 pr oduct 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 medicina l products or waste materials derived 
from the use of such products and, if appropriate, additional precautions as regarding hazardous waste disposal of unus ed 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 shal l appear in easily legible and clearly 
comprehensible characters, or, where appr opriate, abbreviati ons or pictograms 
common throughout the Union. 
3. Where there is no outer packaging, all th e particulars listed in paragraph 1 shall 
appear on the immediate packaging. 
Article 11 
Labelling of small immediate packaging un its of veterinary medicinal products 
By way of derogation from Artic le 9, small immediate packagi ng 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"; EN 30   EN (d) the expiry date, in the format: " mm/yyyy", preceded by the abbreviation 
"Exp.". 
Article 12 
Package leaflet of vete rinary 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 authorisati on holder and of the manufacturer and, 
where applicable, of the representative of the marketing au thorisation holder; 
(b) the name of the veterinary medicinal produc t  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 medicina l products or waste materials derived 
from the use of such products and, if  appropriate, additional precautions 
regarding hazardous waste disposal of unus ed 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 informati on is not promotional. This additional 
information shall appear in the package leaf let 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.  EN 31   EN Article 13 
Package leaflet of homeopathic veterinary medicinal products 
By way of derogation from Ar ticle 12(1), the package leafle t 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 Eu ropean 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 a nd, 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 informati on on the labelling shal l be determined by 
Member State where the veterinary medi cinal product is made available on the 
market. 
2. Member States shall communicate the langua ges determined by them for the purpose 
of paragraph 1 to the Commission. The Co mmission 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 EN 32   EN 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 a ll the following conditions are fulfilled: 
(a) the application satisfies the re quirements set out in Annex III; 
(b) the applicant can demonstrate that the a pplication concerns a generic veterinary 
medicinal product of a veterinary medici nal product which ha s 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 co mpetent authority or to the Agency.  
2. For the purpose of this Sect ion, 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 ve terinary 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 prope rties with regard 
to safety or efficacy. Where it  differs significantly in resp ect of those properties, the 
applicant shall submit additional informati on in order to prove the safety and/or 
efficacy of the various salts, esters or deri vatives 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 co mpetent 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 characteristic s of the generic veterinary medicinal 
product shall be identical to that of th e reference veterinary medicinal product. 
However, that requirement shall not appl y to those parts of the summary of the 
product characteristics of the reference ve terinary medicinal product that refer to 
indications or pharmaceutical forms which are still covered by patent law at the time when the generic veterinary medi cinal product is authorised.   
6. A competent authority or the Agency may re quire the applicant to provide safety data 
concerning the potential risks posed by the generic veterinary medicinal product to 
the environment in case the marketing auth orisation for the reference veterinary 
medicinal product was granted before 20 July 2000 or in case the second phase EN 33   EN environmental risk assessment was require d for the reference ve terinary medicinal 
product.  
7. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 146 concerning amendments to Annex III in order to adapt the requirements 
to technical and sc ientific 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 combin ation of active substan ces that have each 
already been used in authorised veterinary me dicinal products, but have not hitherto been 
authorised in that combination (‘combination ve terinary medicinal product’) shall satisfy the 
following criteria: 
(a) the application satisfies the re quirements set out in Annex III; 
(b) the applicant can demonstrate that th e 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 appr opriate pre-clinical 
studies and clinical trials shall be requi red when the product does not meet all the 
characteristics of a generic vete rinary medicinal product because: 
(a) there are changes in the active substanc e(s), therapeutic in dications, strength, 
pharmaceutical form or route of admini stration of the ge neric veterinary 
medicinal product compared to the refere nce veterinary medicinal product, or 
(b) bioavailability studies cannot  be used to demonstrat e bioequivalence with the 
reference veterinary medicinal product, or 
(c) there are differences relating to raw mate rials or in manufact uring 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 Un ion or in third countries.  
When the batches are manufactured in third coun tries, 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 pr oduct shall not be re quired to provide the documentation on EN 34   EN 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 therei n 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 app lications 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 ma rket shall be granted although the quality 
and/or efficacy documentation required in accordance with Annex II has not been 
provided, if all the follo wing conditions are met: 
(a) the benefit of the immediate availabil ity on the market of the veterinary 
medicinal product to the animal  or public health outwei ghs the risk inherent in 
the fact that certain documen tation 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 grante d a marketing authorisation in accordance 
with this Article, the summar y of product characteristics sh all 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 appli cant 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 grante d subject to any of the following: 
(a) a requirement to introduce conditions or restrictions, in particular concerning 
the safety of the veterinary medicinal product; EN 35   EN (b) a requirement to notify the competent auth orities of any incident relating to the 
use of the veterinary medicinal product; 
(c) a requirement to conduct pos t-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 grante d a marketing authorisation in accordance 
with this Article, the summar y of product characteristics sh all 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 produc t regarding the quality, safety and 
efficacy documentation provided.  
2. During the process of assessing applica tions 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 Un ion 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 sample s of the veterinary medi cinal product to the Union 
reference laboratory, an Offi cial Medicines Cont rol 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 othe r 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 appl icant, 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 EN 36   EN accordance with Regulation (EC) No  470/2009 and Commission Decision 
2002/657/EC25.  
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 cont rol tests in accordance with the methods described in the 
documentation submitted in support of the app lication 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 in form the applicant if the documentation submitted in support 
of the application is insufficient. The compet ent 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 applicati on for marketing authorisation submitted to 
a competent authority or the Agency at a ny time before the decision referred to in 
Article 31 or 32 has been taken.  
2. If an applicant withdraws his applicati on 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 comp leted, the applicant shall communicate its 
reasons for doing so to the competent au thority 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 compet ent authorities or 
the Agency, after deletion of any co mmercially confidential information. 
Article 28 
Outcome of the assessment  
1. In case of favourable assessment to gran t a marketing authorisation, the competent 
authority or the Agency examining the app lication shall prepare an opinion including 
the following documents: 
(a) a summary of the product characteristics containing the information laid down 
in Article 30; 
                                                 
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). EN 37   EN (b) details of any conditions or restrictions to be imposed as regards the supply or 
use of the veterinary medicinal produc t 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 la belling and package leaflet. 
2. Where the application concerns a veteri nary 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 speci es, as established by the Commission in 
accordance with Regulation (EC) No 470/2009. 
3. Where the application concerns an antimic robial veterinary medicinal product, the 
competent authority or the Commission ma y 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 cont ain 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 pa thological processes which require a 
precise prior diagnosis or the use of wh ich may have effects which impede or 
interfere with subsequent diagnos tic or therapeutic measures;  
(e) officinal formulae intended for food-producing animals; 
(f) veterinary medicinal products containi ng 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 veteri nary prescription where spec ial 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 paragra ph 1, a competent authority or the Agency 
may not classify a veterinary medicinal pr oduct as subject to ve terinary prescription 
if all of the following conditions are fulfilled: EN 38   EN (a) the administration of the veterinary medicinal product is restricted to 
pharmaceutical forms requiring no particul ar knowledge or skill in using the 
products; 
(b) the veterinary medicinal product does not pr esent a direct or indirect risk, even 
if administered incorrectly, to the anim al(s) treated, to the person administering 
the product or to the environment; 
(c) the summary of the product characteristic s 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 produc t nor any other product containing the 
same active substance has previously b een the subject of frequent adverse 
event reporting; 
(e) the summary of the product characteristic s does not refer to contraindications 
related to other veterinary medici nal 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 vete rinary 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 substa nces are used incorrectly. 
Article 30 
Summary of the product characteristics 
1. The summary of the product characteristic s 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, includi ng special precautions to be taken by the 
person administering the medici nal 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, EN 39   EN (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, in cluding restrictions on the use of 
antimicrobials in order to limit the ri sk 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 r econstitution of the me dicinal 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 sc hemes for veterinary medicinal products 
for the disposal of unuse d veterinary medicinal products or waste materials 
derived from the use of such produc ts and, if appropriate, additional 
precautions regarding hazardous waste dis posal 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 produc t 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 ve terinary medicinal product that refer to 
indications or pharmaceutical forms which ar e protected by patent law in a Member 
State at the time of placing the generic ve terinary medicinal product on the market 
may be omitted.  EN 40   EN Article 31 
Decisions granting mark eting authorisations 
1. Decisions granting marketing authorisati ons shall be taken on the basis of the 
documents prepared in accordance with Ar ticle 28 and shall set out the conditions 
attached to the placing on th e market of the veterinary medicinal product and the 
summary of the product charac teristics (‘terms of the marketing authorisation’).  
2. The competent authority or the Commissi on 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 veteri nary 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 suffi ciently demonstrated the benefits of 
the product to the animal health and welfare or public health; 
(d) the product is an antimicrobial veterina ry medicinal product presented  for use 
as performance enhancer in order to pr omote 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 imme diate packaging, the outer packaging 
and the package leaflet of the veteri nary medicinal product does not comply 
with the requirements set out in Articles 9 to 11; 
(g) risk for public health in case of de velopment 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 antimicrobi al veterinary medici nal product shall be 
refused if the antimicrobial is reserved for treatment of certain infections in humans.  
3. The Commission shall be empowered to a dopt 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 implem enting acts, designate antimicrobials or 
groups of antimicrobials reserved for trea tment of certain infections in humans. 
Those implementing acts shall be adopted  in accordance with the examination 
procedure referred to in Article 145(2).  EN 41   EN 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 qual ity, safety and efficacy originally 
submitted with a view to obtaining a marke ting 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 au thorisation 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 agr eement in the form of a letter of access 
with regard to that documentation. 
2. The protection of the tec hnical documentation as referre d 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 mark eting authorisation only with regard to 
strengths, pharmaceutical forms, administration routes or presentations shall be regarded as the same marketing authorisa tion as the one previously granted for the 
purpose of applying the rules of the pr otection 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 pr oducts for cattle, sh eep, pigs, chickens, 
dogs and cats; 
(b) 14 years for antimicrobial ve terinary medicinal products  for cattle, sheep, pigs, 
chickens, dogs and cats containing an an timicrobial active substance which has 
not been an active substance in a ve terinary medicinal product authorised 
within the Union on the date of th e 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 gran ted in accordance with Article 7. 
Article 35 
Prolongation of the periods of the pr otection of techni cal documentation 
1. Where a variation is approved in accordan ce with Article 65 extending the marketing 
authorisation to another species listed in Article 34(1)(a), the pe riod of the protection 
provided for in that Article shall be prolonged by 1 year  for each additional target EN 42   EN species, provided that the variation has b een 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 accordan ce with Article 65 extending the marketing 
authorisation to a another species not list ed 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 firs t marketing authorisation prolonged by any 
additional periods of protection due to any variations or new authorisations 
belonging to the same marketing authorisat ion ('overall period of the protection of 
technical documentation') shall not exceed 18 years.  
4. Where an applicant for a marketing author isation for a veterinary medicinal product 
or for a variation to the terms of the mark eting authorisation s ubmits an application 
in accordance with Regulation (EC) No  470/2009 for the establishment of a 
maximum residue limit, together with clini cal trials during the a pplication procedure, 
other applicants shall not use those trials for a period of 5 years from the granting of 
the marketing authorisation for which th ey were carried out, unless the other 
applicant has obtained written agreement in th e 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 th e consequential practical  requirements shall 
not be regarded as contrary to patent-related ri ghts or to supplementar y-protection certificates 
for medicinal products. 
Chapter III 
Procedures for granting ma rketing authorisations  
SECTION 1 
MARKETING AUTHORISATIONS VALID THROUGHOUT THE UNION 
(‘CENTRALISED MARKETING AUTHORISATIONS ’)  
Article 38 
Scope of the centralised mar keting authorisation procedure 
1. Centralised marketing authorisations shall be granted by the Commission in 
accordance with this Section. They sh all be valid throughout the Union.  
2. Centralised marketing authorisation proce dure shall apply in respect of the following 
veterinary medicinal products: 
(a) veterinary medicinal products develope d by means of one of the following 
biotechnological processes: 
(i) recombinant DNA technology; (ii) controlled expression of genes codi ng for biologically active proteins in 
prokaryotes and eukaryotes includi ng transformed mammalian cells; 
(iii) hybridoma and monoclonal antibody methods; EN 43   EN (b) veterinary medicinal pr oducts intended pr imarily 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 containi ng an active substance which has not 
been authorised as a veterinary medicina l product within the Union at the date 
of the submission of the application; 
(d) biological veterinary medicinal produc ts which contain or consist of 
engineered allogeneic tissues or cells; 
(e) generic veterinary medicinal products  of reference veterinary medicinal 
products authorised under the centr alised 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 medici nal 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 delegate d 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 au thorisations shall be submitted to the 
Agency. The application shall be accompan ied by the fee payable to the Agency for 
the examination of the application.  
2. The application for a centralised authoris ation of veterinary medicinal product shall 
state a single name for the veterinary medicinal product to be used throughout the 
Union. 
3. Translations of the labe lling, 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 a pplication for marketing authorisation for a 
veterinary medicinal product, the Agency sh all draw up an opinion as referred to in 
Article 28.  
3. The opinion shall be given within 210 da ys 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 intere st, 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 da ys shall be reduced to 150 days. EN 44   EN 5. The opinion of the Agency shall be forwar ded 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 th e opinion. In such cas e, Article 41 shall 
apply.  
6. After the completion of the pr ocedure referred to in para graph 5 the opin ion 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 sh all provide a response to this request 
within 90 days.  
8. Within 15 days of receipt of the opini on, the Commission shall prepare a draft of the 
decision to be taken in resp ect of the application. Wher e a draft decision envisages 
granting of a marketing aut horisation, it shall include or make reference to the 
documents listed in Article 28. Where the dr aft decision is not in  accordance with the 
opinion of the Agency, the Commission shal l 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 implemen ting acts, take a final decision on the 
granting of a centralised marketing author isation. Those implemen ting acts shall be 
adopted in accordance with the examination procedure refe rred to in Article 145(2).  
10. The Agency shall disseminate the documen ts 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-examina tion 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 conc lusions 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 gran ted 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.  EN 45   EN 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 ma rketing authorisati on for a veterinary 
medicinal product shall be completed w ithin a maximum of 210 days after the 
submission of the complete application.  
2. Competent authorities shall make the a ssessment 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 sh all be granted by the competent authorities 
in accordance with this Section. They shal l be valid in the Member States stated 
therein.  
2. Decentralised marketing authorisations shal l only be granted in respect of veterinary 
medicinal products for which no national mark eting authorisation has been granted at 
the time of application for a decentralise d 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 a pplication, the reference Member State shall 
prepare an assessment report. The assessm ent 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 Me mber States and the applicant, together 
with the list of the Member States concerned.  EN 46   EN 4. Within 90 days after receipt of the docum ents 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 obj ections to the assessment report, summary 
of product characteristics, la belling and package leaflet. 
5. Where all Member States agree, the re ference Member State shall record the 
agreement, close the procedure and inform  the applicant and the Member States 
accordingly. Each Member State from the lis t referred to in paragraph 2 shall grant a 
marketing authorisation in conformity with the approved assessment report, summary of the product characteristics, la belling 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 Me mber State concerned invokes the reasons 
referred to in Article 113(1) for prohibiti ng the veterinary medi cinal product it shall 
no longer be considered as a Member Stat e where the applican t seeks to obtain a 
marketing authorisation. However, a Me mber State having invoked those reasons 
may subsequently recognise the marketing authorisation in accordance with Article 57. 
7. Competent authorities shall make the a ssessment 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 recogniti on marketing authorisation 
A national marketing authorisati on 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 mark eting 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 betw een 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 applican t seeks to obtain 
recognition of the mark eting authorisation; 
(b) copies of marketing authorisations gran ted for the veterinary medicinal product 
in other Member States; EN 47   EN (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 character istics proposed by the applicant;  
(e) the text to appear in the labelling and package leaflet;  
(f) information on refusals to grant a market ing 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 a pplication, the reference Member State shall 
prepare an updated assessment report for the veterinary medicinal product. The updated assessment report together with  the approved summa ry of the product 
characteristics and the text to appear in the labelling and package leaflet shall be 
forwarded to all Member States and the appl icant, 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 docum ents 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, labell ing and package leaflet. 
6. Where all Member States agree, the re ference 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 shal l grant a marketing 
authorisation in conformity with the a pproved assessment report, summary of the 
product characteristics, labelling and package l eaflet 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 c oncerned Member State invokes the reasons 
referred to in Article 113(1) for prohibiti ng the veterinary medicinal product, it shall 
no longer be considered as a Member Stat e where the applican t seeks to obtain a 
marketing authorisation. However, a Me mber State having invoked those reasons 
may subsequently recognise the marketing authorisation in accordance with Article 57. 
8. Competent authorities shall make the a ssessment 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, w ithin 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 pack age 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 disagreemen t 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.  EN 48   EN 2. Within the coordination group, a rapporteur sh all 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 shal l adopt an opinion by a majority of the 
votes cast by the members of the coordi nation 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 r eceipt of the information regarding the 
agreement from the reference Member State.  
6. In the event of an unfavourable opinion, th e 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 annexe d 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 writt en notice to the Agency requesting a re-
examination of the assessment report. In th at case the applicant shall forward to the 
Agency detailed grounds for the request with in 60 days of receipt of the assessment 
report. The application shall be accompanie d 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 se t up by Article 139 (‘the Committee’) shall 
re-examine the assessment report. The reas ons for the conclusion reached shall be 
annexed to the opinion. 
3. The re-examination procedur e shall deal only with the points of the assessment 
report identified by the appli cant in the written notice. 
4. Within 15 days of its adoption, the Ag ency shall forward the opinion of the 
Committee to the coordination group, toge ther with a report describing the 
assessment of the veterinary medicina l product by the Committee and stating the 
reasons for its conclusions. Those documen ts shall be forwarded to the Commission, 
to Member States and to the a pplicant for information purposes.  
5. Upon presentation of the Agency's opini on, 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 c oordination group shal l annex a detailed 
explanation of the reasons for the differences. EN 49   EN 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 medicina l products (‘product data base’) shall be set 
up and maintained by the Agency.  
2. The product database shall contain information on: 
(a) veterinary medicinal produc ts authorised within the Union by the Commission 
and by the competent authorities, toge ther 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 wh ere 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 el ectronic 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, usi ng the format referred to in paragraph 3. 
5. The Agency shall submit information on marketing authorisations granted by the 
Commission to the product da tabase, using the format referred to in paragraph 3. 
6. Within 12 months from the date of app lication of this Regulation, the competent 
authorities shall submit electronically in formation on all veterinary medicinal 
products authorised in their Member State before the date  of application of this 
Regulation to the Agency, using the fo rmat referred to in paragraph 3. 
7. The Agency shall, in collaboration with  Member States and the Commission, draw 
up the functional specificati ons for the product database. 
8. The Commission shall ensure that informa tion reported to the product database is 
collected, collated and made accessible a nd that the information is shared.  
Article 52 
Access to the product database 
1. The competent authorities, the Agency a nd 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.  EN 50   EN 3. The general public shall have access to information in the product database as 
regards the list of the authorised veterina ry medicinal products, their summaries of 
product characteristics a nd package leaflets.  
SECTION 2 
 PLACING ON THE MARKET  
Article 53 
Placing on the market 
1. Marketing authorisation holders shall reco rd 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 sh all not be placed on the market until the 
period of the protection of technical doc umentation for the reference veterinary 
medicinal product as set out in Ar ticles 34 and 35 has elapsed.  
Article 54 
Collection of data on the sales and use of ant imicrobial veterinary medicinal products 
1. Member States shall collect relevant and co mparable data on the volume of sales and 
the use of veterinary antimi crobial medicinal products.  
2. Member States shall send data on the vol ume of sales and the use of veterinary 
antimicrobial medicinal products to the Ag ency. The Agency shall analyse the data 
and publish an annual report. 
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 146 in order to estab lish 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 th is 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 vete rinary medicinal produc t and in order to 
take account of scientific and technical pr ogress, the marketing authorisation holders 
shall ensure that any changes that may be required to enable  that veterinary 
medicinal product to be manufactured and ve rified by means of generally accepted 
scientific methods are introduced. The introdu ction of such changes shall be subject 
to the procedures laid down in Section 4 of this Chapter.  
2. Competent authorities may require marketi ng 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 th e implementation of the analytical method EN 51   EN for detecting residues of the veterinary me dicinal products in the national reference 
laboratory designated under Council Directive 96/23/EC26. 
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 be nefit-risk balance remains favourable.  
5. The marketing authorisation holder shal l without delay inform the competent 
authority or the Commission of any pr ohibition or restriction imposed by a 
competent authority and of any other ne w information which might influence the 
assessment of the benefits and risks of th e veterinary medicinal product concerned.  
6. Upon request from a competent author ity, 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 na tional helpdesks. 
2. National helpdesks shall pr ovide advice to applicants , marketing authorisation 
holders, manufacturers, importers and any othe r interested parties which are small or 
medium-sized enterprises on their res ponsibilities and obligations under this 
Regulation and on applications for the au thorisation of veterinary medicinal 
products.  
SECTION 3 
SUBSEQUENT RECOGNITION IN THE MUTUAL RECOGNITION AND 
DECENTRALISED MARKETING AUTHORISATION PROCEDURES  
Article 57 
Subsequent recognition of marketing author isations by other Member States 
1. After completion of a mutual recognition procedure laid down in Article 48 or a 
decentralised procedure laid down in Artic le 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 authoris ations 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 asse ssment report referred to in Articles 46(3) 
                                                 
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). EN 52   EN and 48(4) or, where appropriate, an updated assessment report, summary of the 
product characteristics, labelling and package l eaflet within 30 days of receipt of the 
documents listed in paragraph 1.  
3. Paragraphs 1 and 2 shall not apply to vete rinary medicinal produc ts that have been 
authorised through a mutual recognition or d ecentralised procedure before the date of 
the application of this Regulation.  
4. Recognition of marketing authorisations fo r 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 veterina ry medicinal product as referred to in 
Article 31 (‘variation’).  
2. The Commission shall, by means of implemen ting acts, establish a list of variations 
to the terms of a marketing authorisation fo r a veterinary medici nal product requiring 
assessment (‘variations requiring assessment ’). Those implementing acts shall be 
adopted in accordance with the examination procedure refe rred to in Article 145(2).  
3. The Commission shall take account of th e following criteria when adopting those 
implementing acts: 
(a) the need for a scientific assessment of ch anges 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 conse quential changes to the summary of the product ch aracteristics, 
the labelling or the package leafle t, those changes shall be consider ed 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 aut horisation 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 au thorities or, where the vete rinary medicinal product is 
authorised under the centralised marketing authorisation procedure, the Commission 
shall amend the decision granting a marketi ng authorisation in accordance with the 
change. EN 53   EN Article 61 
Application for variations requiring assessment 
1. Marketing authorisation holder shall subm it 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 authorisatio ns 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 marketi ng authorisations granted under the 
mutual recognition or decentralised pro cedures, a list of Me mber States which 
granted those marke ting 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 hol der and granted by different competent 
authorities and/or the Commission, the ma rketing authorisation holder shall submit 
an application to all competent au thorities 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 dow n in Article 64.  
3. Where none of the marketing authorisations re ferred to in paragraph 1 is a centralised 
marketing authorisation, the coordination group shall assign a competent authority 
among those having granted the marketing auth orisations 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 r eceipt 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 applicat ion within a reasonable deadline. 
3. The competent authority or the Agenc y, 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, EN 54   EN 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 forwar ded to the applicant.  
6. Where the opinion is prepared by the Agen cy, the opinion shall be forwarded to the 
Commission. Where the Agency assesses the ap plication in accord ance 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 forwarde d to all competent authorities concerned.  
8. Within 15 days of receipt of the opini on, the applicant may submit a written request 
to the Agency or the competent author ity for a re-examination of the opinion. 
Detailed grounds for requesting a re-examinati on 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 appli cant 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 pr ocedure laid down in Article 64(6) and (7) 
a competent authority or the Commission sh all amend the marketi ng authorisation or 
reject the variation and info rm the applicant of the grounds  for the rejection. In case 
of centralised marketing authorisation, the Commissi on 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 accord ance with the opinion of the Agency, the 
Commission shall annex a detailed explanat ion 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 sha ll 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 shal l amend the marketing authorisation granted 
by it or reject the variation in line with the opinion prepared by th e competent authority 
assigned in accordance with Article 63(3). EN 55   EN 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 authorisati on holder may implement a va riation requiring assessment 
only after a competent authority or th e Commission has amended the decision 
granting the marketing authorisation in accord ance 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 dela y 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 characteri stics shall be prepared in accordance 
with the procedure laid dow n in Article 69 for veterina ry 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 author isations have been granted in different 
Member States before 1 January 2004 (‘similar products’).  
2. For the purposes of determining qualit ative and quantitative composition of the 
active substances, different sa lts, esters, ethers, isomer s, mixtures of isomers, 
complexes and derivatives of an active substa nce shall be consider ed to be the same 
active substance, unless they differ significantly  in properties with regard to safety or 
efficacy.  
Article 69 
Procedure for harmonisation of summa ries 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 auth orisations have been granted before 1 
January 2004.  
2. The coordination group shall establish gr oups of similar products. For each of the 
groups of similar products, the coordinati on group shall appoint one member to act 
as a rapporteur.  
3. Within 120 days of his appointment, the rapporteur shall pres ent the coordination 
group a report regarding possible harm onisation 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 characteri stics for veterinary medicinal products 
shall contain all of the following information:  EN 56   EN (a) all species mentioned in the marketi ng authorisations granted by Member 
States in respect of the si milar 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 pe riod of those stated in the summaries of the product 
characteristics.  
5. Upon presentation of a repor t, the coordination group shal l act by a majority of the 
votes cast by the members of the coordi nation group represented at the meeting. The 
rapporteur shall record the agreement, clos e the procedure and inform Member States 
and the marketing authorisa tion holders accordingly.  
6. In the event of an opinion in favour of adopting a harmonised summary of the 
product characteristics, each Member State sh all vary a marketi ng 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 unfavour able opinion, the procedure referred to in Article 49 shall 
apply. 
Article 70 
Harmonisation of summary of products c haracteristics following reassessment 
1. By way of derogation from Article  69, the Committee may recommend to the 
Commission groups of similar veterinary me dicinal 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 implem enting acts, adopt decisions on groups of 
product for which a reassessment is nece ssary. Those implementing acts shall be 
adopted in accordance with the examination procedure refe rred to in Article 145(2).  
3. By way of derogation from Article 69, ve terinary medicinal products authorised 
before 20 July 2000 as well as veterinary medicinal products aut horised after that 
date but which were identified as potenti ally harmful to the environment in the 
course of the environmental risk assessment shall be reassessed before a harmonised summary of the product charac teristics is prepared.  
4. For the purposes of paragra phs 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 simila r products identified for a 
harmonisation of the summaries of the product  characteristics shall submit information 
concerning their products. EN 57   EN SECTION 6 
PHARMACOVIGILANCE  
Article 72 
Pharmacovigilance system of th e marketing authorisation holder 
1. Marketing authorisation holde rs shall elaborate and maintain a system for collecting 
information on the risks of veterinary medi cinal products as regards animal health, 
public health and the environment enabling them to fulfil their pharmacovigilance responsibilities listed  in Articles 73, 76 and 77 (‘pha rmacovigilance 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 maintain ing a system to monitor the safety of 
authorised veterinary medicinal products, en abling them to fulfil their responsibilities 
as listed in Articles 77 and 79 (‘U nion pharmacovigilance system’).  
2. Competent authorities, the Agency and ma rketing authorisation holders shall make 
available to healthcare professionals and an imal holders different means of reporting 
to them the following events whether or not  the event is consid ered 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 fo llowing administration of a veterinary 
medicinal product to an animal; 
(d) any infringements of withdrawal period following administration to an animal 
of a veterinary or hum an 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 establ ished 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 inform ation reported to the pharmacovigilance 
database is uploaded and made acce ssible in accordance with Article 75. EN 58   EN 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 report ed 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 medi cinal 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 reco rd in the pharmacovigilance database all 
adverse events which were reported to th em 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, w ithin 30 days followi ng the receipt of the 
adverse event report. 
3. Competent authorities may, on their own in itiative or on request from the Agency, 
request the marketing authorisation holde r 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 th e 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. EN 59   EN 2. Where the pharmacovigilance tasks have been contracted out by the marketing 
authorisation holder to a third party, those arrangements sha ll 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 re sponsible 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 re sponsible 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 sha ll, based on pharmacovigilance data and 
where necessary, submit changes to the te rms of a marketing authorisation in 
accordance with Article 61. 
6. The marketing authorisation holder sha ll not communicate information regarding 
adverse events to the general public in rela tion to the veterinary medicinal product 
without giving prior notifica tion of his intention to th e competent authority or 
authorities having granted the marketing authorisation or to the Agency where the marketing authorisation was granted in acco rdance with the centralised authorisation 
procedure.  
Where the marketing authorisation holder communicates such information to the general 
public, he shall ensure that it is pres ented 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 author isation 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 pharm acovigilance system master file and 
communicating the reference number of th e 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 accessi ble at least at one site in the Union; 
(e) preparing the adverse event repo rts referred to in Article 76; 
(f) ensuring that collected adverse ev ent reports are recorded in the 
pharmacovigilance database; EN 60   EN (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 medicina l 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 balanc e of a veterinary 
medicinal product, including appropria te information on post-marketing 
surveillance studies; 
(i) evaluating by means of the pharmacovi gilance system all information, 
considering options for risk mini misation 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 th ird 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 con cerning marketing authorisations where 
necessary. 
2. Competent authorities shall take all appr opriate 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 th e reporting of adverse events. The Agency 
and the competent aut horities 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 sp ecific pharmacovigilance data.  
4. Competent authorities and the Agency sha ll provide the general public, veterinarians 
and other healthcare professi onals with all important information on adverse events 
relating to the use of a veterinary medicina l product in a timely manner electronically 
or through other publicly availa ble means of communication. 
5. Competent authorities shall verify by mean s of inspections referred to in Article 125 
that marketing authorisation holders co mply with the requirements relating to 
pharmacovigilance laid dow n in this Section.  
6. The Agency shall evaluate the adverse even ts to the centrally authorised veterinary 
medicinal products, manage risks and reco mmend measures to the Commission. The 
Commission shall take the measures referred  to in Articles 130 to 135 concerning 
marketing authorisations where necessary. EN 61   EN Article 80 
Delegation of tasks by competent authority  
1. A competent authority may delegate any of th e tasks entrusted to it as referred to in 
Article 79 to a competent authority in an other Member State subject to the written 
agreement of the latter.  
2. The delegating competent authority sha ll 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 sha ll cooperate in monitoring the data in the 
pharmacovigilance database to determine whet her there is any change to the benefit-
risk balance of veterinary medicinal products with a view to detec ting risks to animal 
health, public health and protection of  the environment (‘signal management 
process’). 
2. Competent authorities and th e Agency shall establish groups  of veterinary medicinal 
products for which signal ma nagement process can be co mbined with a view of 
detecting risks to animal health, public he alth and protection of the environment. 
3. The Agency and the coordination group shal l agree on sharing of  the monitoring of 
data on groups of veterinary medicinal products recorded in the pharmacovigilance 
database. For each group of veterinary me dicinal products a competent authority or 
the Agency shall be appointed as respons ible for the monitoring thereof (‘lead 
authority’).  
4. The results of the signal management pr ocess shall be agreed upon by the competent 
authorities and, where appropr iate, 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 marketi ng 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 authorisati on holder. After the in itial 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 Agen cy 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 EN 62   EN authorisation holder complies, if applicable, with the condi tions referred to in Article 
21(1). 
3. When an application for re-examination has been submitted, the limited market 
marketing authorisation shall remain vali d 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 whethe r 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 pe riod 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 de cision 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 co mprehensive 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 involve d, and in particular th e interests of public 
or animal health or of the environment re lated 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 re fer 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 St ates and marketing au thorisation holders 
shall forward to the Agency all available information relating to the Union interest referral.  
3. Where the referral provided for in paragra ph 1 concerns more th an one veterinary 
medicinal product or a therapeutic class,  the Agency may limit the procedure to 
specific parts of the terms of the marketing authorisation.  EN 63   EN Article 85 
Referral procedure 
1. The Agency shall publish information a bout referrals made in accordance with 
Article 84 on its website. Interested part ies shall be invited to provide comments. 
2. The Committee shall consider the referre d matter and shall issue a reasoned opinion 
within 90 days of the date on which the matte r was referred to it. That period may be 
extended by the Committee for a further pe riod of up to 60 days, taking into account 
the views of the marketing aut horisation holders concerned.  
3. Before issuing its opinion, the Committee shall provide the marketing authorisation 
holder with the opportun ity to present explan ations within a spec ified time limit. The 
Committee may suspend the time limit referr ed to in paragraph 2 to allow the 
marketing authorisation holder to  prepare the explanations.  
4. In order to consider the matter, the Co mmittee shall appoint one of its members to 
act as a rapporteur. The Committee may appoi nt independent expert s to give advice 
on specific questions. When appointing su ch 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 Agen cy shall forward the final opinion of the 
Committee to Member States, the Commi ssion and the marketing authorisation 
holder, together with an assessment repor t of the vete rinary medicinal product and 
the reasons for its conclusions.  
Article 86 
Decision following the Union interest referral 
1. Within 15 days after receipt of the opi nion 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 Co mmission shall also set out a detailed 
explanation of the reasons for the differen ces in an annex to the draft decision.  
2. The draft decision shall be fo rwarded to Member States.  
Article 87 
Commission decision following the referral 
1. The Commission shall, by means of implemen ting 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 th e marketing authorisa tion 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 EN 64   EN decision within 30 days of its notification, unless a different  period is foreseen in the 
decision.  
4. In case of centrally authorised veterinary medicinal pr oducts 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, hom eopathic veterinary medicinal products 
that satisfy the requirements set out in Article 89 and are not immunological 
homeopathic veterinary medici nal products shall be regist ered in accordance with 
Article 90. 
2. The competent authorities shall record homeopathic veterinary medicinal products 
registered by them in the data base referred to in Article 51. 
Article 89 
Registration of homeopathic ve terinary medicinal products 
1. Homeopathic veterinary medicinal produc ts 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 pr oduct shall not contain more than one 
part per 10 000 of the mother tincture; 
(c) no specific therapeutic indication appear s on the labelling of the medicinal 
product or in any information relating thereto. 
2. The Commission shall be empowered to a dopt 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 st atement of the various routes of 
administration, pharmaceutical forms and de gree 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 biologica l substances, a description of the measures taken 
to ensure the absence of pathogens; EN 65   EN (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 authorisat ions obtained for th e same veterinary 
medicinal products in other Member States; 
(f) the text to appear on the outer pack aging 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 toge ther 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 fo r the animal species in question, a 
document certifying that a valid applica tion 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 th e competent authority shall determine the 
conditions under which the homeopathic ve terinary 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 authorisati on shall be required in orde r 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 proce ss of producing a veterinary medicinal 
product or of bringing a veterinary medicinal produc t to its final state, 
including engaging in the processi ng, assembling, packag ing, 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 packagi ng or presentation where these processes 
are carried out solely fo r retail in accordance w ith Articles 107 and 108.  
3. The competent authorities shall record th e manufacturing authorisations granted by 
them in the database on manufacturing, im port and wholesale distribution set up in 
accordance with Article 94. EN 66   EN 4. Manufacturing authorisations sha ll be valid throughout the Union.  
Article 92 
Requirements for obtaining a manufacturing authorisation 
1. Applications for manufacturing authorisa tions shall be submitted to a competent 
authority in the Member State where the manufacturing site is located.  
2. An application for a manufacturing authoris ation shall contain at least the following 
information: 
(a) veterinary medicinal products which ar e to be manufactured or imported;  
(b) pharmaceutical forms which are to be manufactured or imported; 
(c) details about the manufacturing site wh ere the veterinary medicinal products 
are to be manufactured or tested; 
(d) statement to the effect that the applican t fulfils the requirements laid down in 
Article 98. 
Article 93 
Granting of manufacturing authorisations 
1. Before granting a manufacturing authorisat ion, the competent authority shall carry 
out an inspection in accordance with Artic le 125 of the manufacturing site where the 
veterinary medicinal products are to be manufactured or tested.  
2. An authorisation shall appl y 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 au thority receives the application.  
4. The competent authority may require the a pplicant to submit further information in 
addition to that supplied in the applica tion 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 authoris ation may be granted cond itionally, subject to a 
requirement for the applicant to undertake actions or introduce specific procedures 
within a given time period. The manufacturi ng authorisation may be suspended if 
these requirements are not complied with. 
Article 94 
Database on manufacturing authorisations 
1. A Union database on manufacturing, impor t and wholesale distri bution shall be set 
up and maintained by the Agency ('ma nufacturing and whol esale distribution 
database').  
2. The database shall include informa tion on any manufactur ing and wholesale 
distribution authorisations granted by competent authorities within the Union. 
3. The Agency shall make public a format fo r electronic submissions of data to the 
database. EN 67   EN 4. Competent authorities shall record in the manufacturing and wholesale distribution 
database information on authorisations a nd certificates granted in accordance with 
Articles 93, 103 and 105 together with in formation on the veterinary medicinal 
products covered by the authoris ations, 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 ma nufacturing and whol esale distribution 
database. 
6. The Agency shall ensure that information reported to the database is collated and 
made accessible and that th e information is shared. 
Article 95 
Access to the database on m anufacturing 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 ma nufacturing or whol esale 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 aut horisation 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 paragra ph 1, the competent authority may request the 
holder to provide supplementary informati on 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 th e holder of the outcome of the assessment 
and where appropriate, amend the manuf acturing authorisation, and update, where 
appropriate, the manufacturing and wholesale distribution database. 
Article 97 
Manufacturing authorisation for import and export  
1. The manufacturing authorisati on 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 re ferred to in Article 104.  EN 68   EN Article 98 
Obligations of the manufacturing authorisation holders  
The holder of a manufacturi ng authorisation shall:  
(a) have at his disposal suit able and sufficient premises, technical equipment and 
testing facilities for th e manufacture, export or import of the veterinary 
medicinal products stated in th e 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 ca rry 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 st aff complying with the legal requirements 
existing in the Member State concerne d as regards both  manufacture and 
controls;  
(f) allow the representatives of the compet ent 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 shal l 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 sha ll 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 author isation shall have permanently and 
continuously at his disposal the services of  at least one qualifie d person who fulfils 
the conditions laid dow n in this Article and is respons ible, 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 au thorisation may himself assume the EN 69   EN responsibility referred to in  paragraph 1, if he personall y 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 produc ts has been manufactured and tested in 
compliance with the terms of the market ing 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 ensu re that each impor ted production batch 
has undergone in the Union a qu alitative and a quantitative an alysis of at least all the 
active substances, and all th e 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 paragr aph 1 shall be valid 
throughout the Union.  
4. The qualified person for manufacturing shall keep records in respec t of each released 
production batch. These records sh all be kept up to date as operations are carried out 
and shall remain at the disposal of the co mpetent authority for a period of 5 years.  
5. Where veterinary medicinal products manuf actured 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 rega rding application of standards of good 
manufacturing practice at least equivalent to thos e laid down in Commission 
Directive 91/412/EEC27 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 re ferred to in paragraph 2.  
Article 102 
Competent authorities' measures  
1. The competent authority shall ensure th at the obligations of qualified persons 
referred to in Article 100 are fulfilled, either by means of appropriate administrative measures or by making such persons subjec t to a professional code of conduct.  
2. The competent authority may tempor arily suspend such persons upon the 
commencement of administrative or disciplin ary proceedings against them for failure 
to fulfil their obligations.  
                                                
 
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). EN 70   EN Article 103 
Certificates of manufacturing authorisations 
Upon request of the manufacturer or exporter of  veterinary medicina l products, or of the 
authorities of an importing th ird country, the competent aut hority shall certify that the 
manufacturer: 
(a) holds a manufacturing authorisation for the product in question, or 
(b) possesses a certificate of good manufacturi ng practice as referre d 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 al ready authorised in their 
territory. 
Chapter VII 
Supply and use 
SECTION 1  
WHOLESALE DISTRIBUTION  
Article 104 
Wholesale distribution of vet erinary medicinal products  
1. The wholesale distribution of veterinary medicinal products shall be subject to the 
holding of a wholesale dist ribution authorisation. Member States shall lay down 
procedures for granting a wholesal e 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 ordere d by the competent authorities or the 
Commission or undertaken in cooperation w ith the manufacturer of the veterinary 
medicinal product in question or marketing authorisation holder. 
5. A wholesale distributor shall supply vete rinary medicinal products only to persons 
permitted to carry out retail activities in the Member State in accordance with Article 107(1), other wholesale distri butors and exporters of vete rinary medicinal products. 
Article 105 
Procedure for granting wholesale distribution authorisations  
1. An application for a wholesale distributi on authorisation shall be submitted to the 
competent authority of the Member State in which the wholes ale distributor is 
established.  
2. The procedure for granting a wholesale di stribution authorisation shall not exceed 90 
days from the date on which the compet ent authority receives an application. 
3. An applicant shall demonstrate in the ap plication that he fulfils the following 
requirements: EN 71   EN (a) has at his disposal tec hnically competent staff and suitable and sufficient 
premises complying with the requirements laid down by the Member State concerned as regards the storage a nd handling of veterinary medicinal 
products; 
(b) has an emergency plan guaranteeing effective implementation of any 
withdrawal ordered by the competen t authorities or the Commission or 
undertaken in cooperation with the manu facturer 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 a pplicant of the outcome of the evaluation, 
grant or refuse the wholesale distributi on authorisation, and upload the relevant 
information of the authorisation in the manufacturing and w holesale 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 vete rinary medicinal product;  
(e) quantity received or supplied;  
(f) name and address of the supplier in the ev ent of purchase or of the recipient in 
the event of sale.  
2. At least once a year the holder of a whol esale distribution aut horisation shall carry 
out a detailed audit of the stock and co mpare 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 prescr ibe veterinary medicinal pr oducts in accordance with 
applicable national law sha ll retail antimicrobial products  only for animals which are 
under their care, and only in the amount required for the treatment concerned. EN 72   EN 3. Retailers of veterinary medicinal produc ts shall keep detailed records of the 
following information in respect of each purc hase 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 even t of purchase, or of   the recipient in 
the event of sale;  
(f) name and address of the prescribing vete rinarian 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 car ry out a detailed audit of the stock and 
compare the incoming and outgoing veterina ry medicinal products recorded with 
products currently held in stock. Any discrepancies f ound 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 medici nal products at a distance 
1. Persons permitted to supply veterinary medicinal products in accordance with Article 
107(1) may offer veterinary medicinal pr oducts 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 establishe d 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 requirement s set out in Article 6 of the Directive 
2000/31/EC of the European Parliament and of the Council29, websites offering 
veterinary medicinal products shall contain at least:  
(a) the contact details of the competent aut hority of the Member State in which the 
retailer offering the veterinary medi cinal products is established;  
(b) a hyperlink to the website of the Memb er State of establishment set up in 
accordance with paragraph 5;  
(c) the common logo established in accordan ce 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 hyper link to the entry 
of the retailer in the list of authorised  retailers referred to in point (c) of 
paragraph 5.  
                                                
 
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 partic ular electronic commerce, in the Internal Market 
('Directive on electronic commerce' ) (OJ L 178, 17.7.2000, p. 1). EN 73   EN 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 webs ites offering veterinary medici nal products for sale at a 
distance.   
4. The Commission shall adopt the desi gn of the common logo by means of 
implementing acts. Those implementing acts shall be adopted in accordance with the 
examination procedure referre d 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 app licable to the offe ring 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 Memb er 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 cont ain 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 thei r territory of medicinal produ cts offered for sale at a 
distance to the public by means of  information society services.  
Article 109 
Retail of anabolic, anti-infectious, anti-par asitic, anti-inflammatory, hormonal or 
psychotropic veterinar y medicinal products 
1. Only manufacturers, wholesal e distributors and retailers authorised specifically to do 
so in accordance with app licable national law shall be allowed to supply and 
purchase veterinary medicinal products wh ich have anabolic, an ti-infectious, anti-
parasitic, anti-inflammatory, hormonal or  psychotropic propert ies or substances 
which may be used as veterinary medici nal products having those properties.  
2. The competent authorities shall maintain  a register of manuf acturers, 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;  EN 74   EN (c) quantity received or supplied;  
(d) name and address of the supplier in the even t of purchase, or of   the recipient in 
the event of sale. 
These records shall be available for inspectio n by the competent authorities in accordance 
with Article 125 for a period of 3 years.  
Article 110 
Veterinary prescriptions 
1. A veterinary prescription sh all 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, qualific ations and profe ssional 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 qua lified 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 r ecognised throughout the Union. A veterinary 
medicinal product prescribed shall be supplied in accordance with applicable 
national law.  EN 75   EN SECTION 3  
USE  
Article 111 
Use of veterinary medicinal products 
1. Veterinary medicinal products shall be us ed 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 te rritory 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 medicina l 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 me dicinal product administered;  
(d) name and address of the supplier; 
(e) identification of the animals treated;  
(f) name and address of the prescribing vete rinarian 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 accord ance with Article 125 for a pe riod 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 a nd/or use of immunol ogical 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 program me for the diagnosis, control or 
eradication of animal disease; 
(b) the administration of the product to anim als may cause difficu lties in certifying 
the absence of contamination in live anim als or in foodstuffs or other products 
obtained from treated animals;  
(c) the disease to which the pr oduct is intended to conf er immunity is largely 
absent from the territory concerned.  EN 76   EN 2. The competent authorities shall inform th e Commission of all instances in which the 
provisions of paragr aph 1 are applied.  
Article 114 
Veterinarians providing services  in other Member States  
1. A veterinarian providing services in a Me mber 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 veteri nary medicinal product on the market 
provided for in Article 5 has been issu ed by the competent authorities of the 
host Member State or by the Commission; 
(b) the veterinary medicinal products are tr ansported 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 me dicinal products auth orised in the host 
Member State;  
(d) the veterinarian follows the good veterina ry 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 veteri nary 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 admi nistered, 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 immunologi cal veterinary medicinal products which 
are not authorised for use in the host Member State. 
Article 115 
Use of medicinal products for species or indi cations outside the te rms of the marketing 
authorisation in non food-producing species  
1. By way of derogation from Article 111, wh ere there is no authorised veterinary 
medicinal product in a Member State fo r a condition affecting a non-food producing 
animal, the veterinarian responsible may, unde r his/her direct personal responsibility 
and in particular to avoid causing unaccep table suffering, exceptionally treat the 
animal concerned with the following:  
(a) a medicinal product: EN 77   EN (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 produ ct authorised under this Regu lation in another Member State 
for use in the same species or in another sp ecies, for the same condition or for another 
condition; 
(iii) a medicinal product for human use auth orised in the Member State concerned in 
accordance with Directive 2001/83/EC of the Eu ropean Parliament and of the Council30 or 
Regulation (EC) No 726/2004;  
(b) if there is no product as re ferred to in point (a), a veterinary medicinal product 
prepared extemporaneously in accorda nce with the terms of a veterinary 
prescription by a person authorised to  do so under national legislation.  
2. The veterinarian may administer the me dicinal product personally  or allow another 
person to do so under the vete rinarian's responsibility.  
3. Paragraph 1 of this Article shall also appl y to the treatment by a veterinarian of an 
animal belonging to the equidae family pr ovided 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 indi cations outside the te rms of the marketing 
authorisation in food-producing species  
1. By way of derogation from Article 111, wh ere there is no authorised veterinary 
medicinal product in a Member State fo r a condition affecting a food-producing 
animal of a non-aquatic spec ies, the veterinarian res ponsible may, under his direct 
personal responsibility and in particular  to avoid causing unacceptable suffering, 
exceptionally treat the animal concer ned with any of the following:  
(a) a veterinary medicinal pr oduct 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 authoris ed under this Regul ation in another 
Member State for use in the same speci es or in another food-producing species 
for the same condition or for another condition; 
(c) a medicinal product for human use author ised 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 re ferred to in point (a), a veterinary medicinal product 
prepared extemporaneously in accorda nce 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, wh ere there is no authorised veterinary 
medicinal product in a Member State fo r a condition affecting a food-producing 
aquatic species, the veterinarian res ponsible may, under hi s direct personal 
responsibility and in particular to avoi d causing unacceptable suffering, treat the 
animals concerned with any of the following medicinal products: 
                                                 
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). EN 78   EN (a) veterinary medicinal products authorised  under this Regula tion in the Member 
State concerned for use with another f ood-producing aquatic species, or for 
another condition in the same aquatic species;  
(b) veterinary medicinal products authoris ed under this Regulation in another 
Member State for use in the same aqua tic 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 pr oduct as referred to in subparagraphs (a) 
and (b) of paragraph 2, a veterinarian ma y, under his direct personal responsibility 
and in particular to avoid causing un acceptable suffering, exceptionally treat food-
producing animals of an aquatic spec ies on a particular holding with:  
 
(a) a veterinary medicinal pr oduct 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 author ised 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 implementi ng 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 anim als of an aquatic species in accordance 
with paragraph 1. Those implementing acts sh all be adopted in accordance with the 
examination procedure refe rred 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 an imals 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 pers onally or allow another person to do so 
under the veterinarian's responsibility.  
6. Pharmacologically active substances incl uded in the medicina l 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 speci fy an appropriate w ithdrawal period in 
accordance with Article 117.  
7. By way of derogation from paragraph 1 a nd from Article 16(1) of Regulation (EC) 
No 470/2009 and in case there is no medicina l product available as referred to in 
paragraph 1, a veterinarian may treat bees , during the period when no honey or other EN 79   EN foodstuffs is produced, with a veterinary me dicinal product authoris ed for bees in a 
third country which is a member or an obs erver of the In ternational Cooperation on 
Harmonisation of Technical Requirements fo r Registration of Ve terinary Medicinal 
Products. 
8. The veterinarian shall keep records of the date of examination of the animals, details 
of the owner, the number of animals trea ted, the diagnosis, the medicinal products 
prescribed, the doses administered, the dura tion of the treatment and the withdrawal 
periods recommended, and shall make those records available for inspection by the 
competent authorities for a pe riod of at least 5 years.  
Article 117 
Withdrawal period for products us ed 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 char acteristics for the species in question, a 
withdrawal period shall be set by the vete rinarian  in accordance with the following 
criteria: 
(a) for meat and offal of food produci ng 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 no t authorised for food pr oducing species, 28 days; 
(b) for animal species producing milk fo r human consumption not less than: 
(i) the longest withdrawal peri od provided in the summary of the product characteristics for 
any milk producing species multiplied by factor 1.5;  
(ii) if the product is no t authorised for any milk producing species, 7 days; 
(c) for animal species producing eggs fo r human consumption not less than: 
(i) the longest withdrawal peri od provided in the summary of th e product characteristics for 
eggs multiplied by factor 1.5; 
(ii) if the product is no t authorised for any eggs  producing species, 7 days; 
(d) for aquatic animal species for human c onsumption and aquatic animal species 
producing eggs for human consumption not less than: 
 (i) the longest withdrawal period for any of th e 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 (‘d egree-days’). The withdrawal period shall not 
be less than 50 degree-days; 
(ii) if the product is not authorised for f ood producing aquatic animal species, 500 degree-
days. 
2. The Commission shall be empowered to a dopt 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 determ ine the appropriate withdrawal period by 
assessing the specific situation of the particular beehive(s)  on a case-by-case basis.  EN 80   EN 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 equid ae 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 produ cts 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 ri sk to public or animal health. 
2. The Commission may, by means of implem enting acts in accordance with the 
examination procedure referred to in Artic le 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 paragra ph 1 subject to certain conditions.  
When adopting those implementing acts, th e Commission shall ta ke 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 deve lopment of antimicrobial resistance; 
(c) availability of other tr eatments for animals, 
(d) availability of other antimic robial 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 authoris ed in that Member State, 
where the situation of animal or public heal th so requires, and the marketing of those 
veterinary medicinal products is au thorised in another Member State. 
2. By way of derogation from Article 111, in th e event of an outbreak of a listed disease 
as referred to in Article 5 of Regulati on (EC) No…/…. of the European Parliament 
and the Council
31 [Office of Publications, please insert number and, in a footnote, 
                                                 
31 Regulation of the European Parliament and the Council of….. on animal health (OJ L……). EN 81   EN 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 medici nal product authorised in another Member 
State. 
Article 120 
Exemption for veterinary medici nal products for certa in animals kept exclusively as pets  
Where veterinary medicinal produ cts are intended solely for a quatic animals, cage birds, 
homing pigeons, terrarium animals, small rodents, ferrets and rabbits kept exclusively as pets, 
Member States may permit exemptions, in thei r territory, from Article 5, provided that such 
products do not contain substances the use of wh ich requires veterinary controls and that all 
possible measures are taken to prevent unautho rised use of the products for other animals. 
Article 121 
Use of immunologicals from third countries  
If an animal is being imported from, or exporte d to, a third country and is thereby subject to 
specific binding health rules, a competent aut hority may permit the use, for the animal in 
question, of an immunological veterinary me dicinal 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 au thority shall supervise the importation and the 
use of such immunological products. 
Article 122 
Disposal of veterinar y 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 veterinar y medicinal products  
1. The advertising of a veterina ry 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 mislea ding 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 ar e available on veterinary prescription 
only; EN 82   EN (b) veterinary medicinal products which cont ain 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 contro ls of manufacturers, importers, marketing 
authorisation holders, whol esale 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 Regul ation are complied with.  
2. The risk-based controls referred to in  paragraph 1 shall be carried out by the 
competent authoritie s 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 wi th the requirements, 
(c) any information that might indicat e 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 re quest of another competent authority, the 
Commission or the Agency. 
4. The inspections shall be carried out by au thorised representatives of the competent 
authority who shall be empowered to:  
(a) inspect manufacturing or supply establis hments and any laboratories entrusted 
by the manufacturing authorisat ion holder with the task of carrying out control 
tests;  
(b) take samples of veterinary medicinal pr oducts 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, documen ts 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.  EN 83   EN 5. After each control, a competent authority shall draft a report on compliance with the 
requirements set out in this Regulation. Befo re adopting a report, the inspected entity 
shall have the opportunity to submit comments. 
6. Inspection reports shall be uploaded to the appropriate databa se, with continuous 
access for all competent authorities. 
Article 126 
Audits by the Commission 
The Commission may carry out audits in Memb er States for the purpose of verifying the 
controls carried out by the competent authoritie s. After each audit, the Commission shall draft 
a report containing, where appr opriate, recommendations to th e 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 cer tificate 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 a nd taking due account of the pr inciples and guidelines on 
good manufacturing practice.  
2. Competent authorities shall enter the certi ficates of good manufact uring practice into 
the database for manufacturing authorisations.  
3. The conclusions reached following an in spection of a manufactur er 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 comp etent authority shall verify that the 
manufacturing processes us ed in the manufacture of  immunological veterinary 
medicinal products are validated and batc h-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 unde rgo an inspection as 
referred to in paragraph 1.  
6. In order to verify whether the data s ubmitted for obtaining a conformity certificate 
comply with the monographs of the Eur opean Pharmacopoeia, the standardisation 
body for nomenclatures and quality norms w ithin the meaning of the Convention on 
the elaboration of a European Pharmacopoeia accepted by Council Decision 94/358/EC
32 (European Directorate for the Qua lity of Medicines & Healthcare) may 
ask the Commission or the Agency to request an inspection when the starting material concerned is subject to a Eur opean 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.  
                                                
 
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 Ph armacopoeia (OJ L 158, 25.6.1994, p. 17). EN 84   EN Article 128 
Specific rules on pharmacovi gilance 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 iden tified in the product databa se, are regularly checked. 
2. The competent authority in the Member  State in which the qualified person 
responsible for pharmacovigilance opera tes shall carry out pharmacovigilance 
inspections. Any work-sharing initiatives and delegation of  responsibilities between 
competent authorities shall ensure that there is no dupl ication 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 pr ovide proof of the cont rol tests carried out 
on the veterinary medicinal product or on the constituents and intermediate products of the manufacturing process, in accord ance with the methods laid down in 
marketing authorisation.  
2. For the purposes of application of paragr aph 1, competent authorities may require the 
marketing authorisation holder for immunol ogical veterinary medicinal products to 
submit to the competent authorities the copi es of all the control reports signed by the 
qualified person in accord ance with Article 101.  
3. The marketing authorisati on 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 compet ent authorities upon request.  
4. Where necessary for reasons of human or animal health, a competent authority may 
require the marketing authorisation hol der for an immunological veterinary 
medicinal product to submit samples of batc hes 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 St ates 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 batche s or the batch in question.  
In such cases, the competent authorities of  another Member Stat e 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 sh all repeat, on the samples prov ided, 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.  EN 85   EN 7. The list of tests to be repeated by the la boratory responsible for the control shall be 
restricted to justified tests, provided th at 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 ce ntralised procedure, 
the list of tests to be  repeated by the cont rol laboratory may be reduced only upon agreement 
of the Agency.  
8. The competent authorities shall reco gnise the results of the tests.  
9. Unless the Commission is informed that a longer period is nece ssary 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 Direct orate for the Quality of Medicines & 
HealthCare, the marketing au thorisation holder and, if a ppropriate, 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 manufact urer or the specifications 
provided for in the marketing authorisati on, it shall take measures vis-a-vis the 
marketing authorisation holder and the ma nufacturer, 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 vete rinary 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 refe r 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 accord ance with Article 61. 
Article 131 
Suspending, withdrawing or varyi ng marketing authorisations  
1. The competent authority or the Commission shall suspend or withdraw the marketing 
authorisation if the benefit-risk balan ce of the veterinary medicinal product is 
unfavourable.  EN 86   EN 2. The competent authority or the Commission shall suspend or withdraw the marketing 
authorisation or request the marketing authorisation holde r to submit an application 
for a variation to the terms of the mark eting authorisation where the withdrawal 
period is inadequate to ensure that foodstu ffs obtained from the treated animal do not 
contain residues which might cons titute a public health hazard. 
3. The competent authority or the Commissi on may suspend or withdraw the marketing 
authorisation or request the marketing authorisation holde r to submit an application 
for a variation to the terms of the marke ting 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 activ e 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 urgenc y of the matter, in order to examine the 
reasons. Whenever practicable, the holder of the marketing authorisation for the 
veterinary medicinal product shall be invite d to provide oral or written explanations. 
5. Following an opinion by the Agency, the Commission shall adopt, where necessary, 
provisional measures, which shall be app lied 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 refe rred to in Article 145(2). 
6. Member States shall lay down procedures  for application of paragraphs 1 to 3. 
Article 132 
Suspending and withdrawing manuf acturing authorisations  
In the event of non-comp liance 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 medi cinal products from third countries; 
(c) suspend the manufacturing authorisation fo r a category of preparations or for 
all preparations; 
(d) withdraw the manufacturing authorisation for a category of preparations or for 
all preparations. EN 87   EN Article 133 
Prohibiting supply of veter inary medicinal products 
1. In duly justified cases, the competent aut hority or the Commission shall prohibit the 
supply of a veterinary medicinal product and require the mark eting authorisation 
holder to withdraw the veterinary medicina l product from the market if any of the 
following apply:  
(a) the benefit-risk balance of the veteri nary medicinal product is unfavourable; 
(b) the qualitative and quantitative composition of the veterinary medicinal 
product is not as stated in the summar y 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 Articl e 129(1) have not been carried out.  
2. The competent authorities or the Commi ssion 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 con cerning the initiatio n, 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 conditi ons 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 financ ial penalty, it shal l publish a concise 
summary of the case, including the names of the marketing au thorisation holders 
involved and the amounts of and reasons fo r the financial penalties imposed, having 
regard to the legitimate interest of th e marketing authorisation holders in the 
protection of their business secrets. 
Article 135 
Penalties imposed by the Commission 
1. The Commission may impose financial pe nalties on the holders of marketing 
authorisations granted under this Regulation if they fail to observe their obligations 
in accordance with this Regulation.  EN 88   EN 2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 146 laying down rules concerning th e initiation, duration, time-limits and 
conduct of the imposition of fines or periodi c penalty payments to the holders of 
marketing authorisations granted under this Regulation, the maximum amounts of 
these penalties as well as the conditio ns 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 involve d and the amounts of and reasons for the financial 
penalties imposed, having regard to the legitimate interest of the marketing authorisation holders in the prot ection of their bu siness secrets. 
4. The Court of Justice shall have unlimited jurisdiction to review decisions whereby 
the Commission has imposed financial penalt ies. 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 competen t authorities to carry out tasks under this 
Regulation. 
2. The competent authorities sh all 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. Co mpetent authorities shall 
communicate the appropriate information to  each other, particularly regarding 
compliance with the requirements for th e manufacturing and wholesale distribution 
authorisations, for the cert ificates 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 Ar ticle 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 home opathic veterinary medicinal products 
manufactured and marketed within the Union.  
Article 137 
Information to the Agency and international or ganisations from the competent authorities 
1. Each competent authority shall immediately inform the Agency of all decisions 
granting marketing authoris ation and of all decisions  refusing or withdrawing 
marketing authorisation, repealing a d ecision refusing or withdrawing marketing 
authorisation, prohibiting supply or withdr awing 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.  EN 89   EN Article 138 
Scientific opinion for internati onal organisations for animal health 
1. The Agency may give scientific opini ons, in the context of cooperation with 
international organisations for animal h ealth, for the evaluation of veterinary 
medicinal products intended exclusively fo r 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, af ter consulting the relevant organisation, 
draw up a scientific opinion.  
2. The Committee shall establish specific pr ocedural rules for the application of 
paragraph 1. 
Article 139 
Committee for Medicinal Products for Veterinary Use  
1. A Committee for Medicinal Products for Vete rinary Use (‘the Committee’) is hereby 
set up within the Agency.  
2. The Executive Director of the Agency or hi s 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 c onvened by the Agency 
or its committees.  
3. The Committee may establish standing and temporary working parties. The 
Committee may establish scientific advi sory 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 establis h a standing working party with the sole remit of 
providing scientific advice to undertakings. The Execu tive Director, in close 
consultation with the Committee shall set up the administrative structures and 
procedures allowing the development of a dvice 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 rule s of procedure. Thos e rules shall, in 
particular, lay down:  
(a) procedures for appointing a nd replacing the Chairman;  
(b) the appointment of members of any work ing parties or scie ntific 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 a dvisory groups; 
(c) a procedure for urgent adoption of opini ons, particularly in  relation to the 
provisions of this Regulation on market  surveillance and pharmacovigilance.  
The rules of procedure shall en ter into force after receiving  a favourable opinion from the 
Commission and the Management Board of the Agency. 
6. The Secretariat of the Agency shall provid e technical, scientific and administrative 
support for the Committee, and shall ensure  consistency and quality of opinions of 
the Committee and appropriate coordina tion between this Committee, other 
committees of the Agency and the coordination group. EN 90   EN 7. The opinions of the Committee shall be publicly accessible. 
Article 140 
Members of the Committee for Medici nal 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 Comm ittee shall be appointed on the basis of 
their relevant expertise and experience in  the scientific eval uation of medicinal 
products for veterinary use, in order to gu arantee the highest leve l of qualifications 
and a broad spectrum of relevant expertise. 
3. Member States shall submit relevant info rmation to the Management Board of the 
Agency on expertise and experien ce in relation to the scient ific profile es tablished 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 referre d to in paragraph 4, each Member State 
shall appoint one Member and one alternat e 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 competen ce. 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 expert s nominated by Member States or the 
Agency.  
9. The members of the Committee may be accomp anied 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 scientif ic evaluation and resources available to 
competent authorities. Each authority sha ll monitor and ensure the scientific level 
and independence of the evaluation carri ed out and the provision of appropriate 
contribution to the tasks of the Committee, and facilitate the act ivities of appointed 
Committee members and experts. To this e nd, Member States shall provide adequate 
scientific and technical resources to the me mbers and experts they have nominated.   
11. Member States shall refrain from  giving Committee members and experts 
instructions incompatible w ith their own individual tasks,  or with the tasks of the 
Committee and responsibilities of the Agency.  EN 91   EN Article 141 
Tasks of the Committee for Medici nal Products for Veterinary Use 
1. The Committee shall have the following tasks: 
(a) carry out the tasks conferred on th e Committee under this Regulation and 
Regulation (EC) No 726/2004; 
(b) prepare opinions of the Agency on questi ons 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 ques tions concerning the admissibility of 
files submitted in accordance with the centralised procedure, and on granting, 
varying, suspending or withdrawing a ma rketing 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 recogni tion or decentralised procedures; 
(g) provide guidance on important questions a nd issues of general scientific or 
ethical nature 
(h) give a scientific opini on, in the context of coope ration with international 
organisations for animal health, concerni ng 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 appr opriate coordination 
between the tasks of the Agency and th e work of competent authorities.  
3. When preparing opinions the Committee sh all use its best endeavours to reach a 
scientific consensus. If such consensus cannot be reached, the opinion shall consist 
of the position of the major ity 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 Comm ittee 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 adviso ry 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 rec ognition and decentralised procedures for 
veterinary medicinal products ("the coordination group") is  hereby set up.  EN 92   EN 2. The Agency shall provide a secretariat fo r 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 rule s of procedure, which shall enter into 
force after receiving a favourable opini on from the Commission. These rules of 
procedure shall be made public.  
4. The Executive Director of the Agency or hi s 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 y ears. 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 sh all monitor the quality  of the evaluations 
carried out by their representative and facilitate their activities. 
3. Members of the coordination group sha ll 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 pharmacovi gilance of veterinary medicinal 
products authorised in Member States; 
(c) examine questions concerning varia tions 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 c onsidered a veterinary medicinal product 
within the scope of this Regulation. EN 93   EN Chapter XI 
Final provisions  
Article 145 
Standing Committee on Veterina ry 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 para graph, 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 referre d 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 Ar ticles 7(7), 16(6), 32(3), 38(4), 54(3), 89(2), 
117(2) and 135(2) may be revoke d 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, th e Commission shall notify it simultaneously to 
the European Parliament and to the Council. 
5. A delegated act adopted pursuant to Artic les 7(7), 16(6), 32(3) , 38(4), 54(3), 89(2), 
117(2) and 135(2) shall ente r into force only if no obj ection 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 Parlia ment 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 Eur opean Parliament or of the Council. 
Article 147 
Data protection  
1. Member States shall apply Directive 95/ 46/EC to the processi ng 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. EN 94   EN  
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 authorisa tions for veterinary  medicinal products 
submitted in accordance with Regulation (EC) No 726/2004 before the date of application of this Regulation shall be ex amined in accordance with Regulation (EC) 
No 726/2004.  
2. Applications for marketing authorisa tions 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 sha ll 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 inse rt date counting 24 months from the 
entry into force]  except for Article 15, Artic le 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 EN 95   EN EN 96   EN EN 97   EN 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 fina ncial 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 ope rational appropriations  
 3.2.3. Estimated impact on appropriati ons 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 revenueEN 98   EN 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 structure33  
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 action34  
 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 strategi c 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 safe ty of veterinary medicinal products and 
the optimal functioning of the internal ma rket. 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, simp lify post authorisati on requirements and 
review incentives for breakthrough medicines. 
ABM/ABB activity(ies) concerned  
To expand the market beyond the top four anim al 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 incenti ves for breakthrough medicines. 
                                                 
33 ABM: activity-based management; ABB: activity-based budgeting. 
34 As referred to in Article 54(2)(a) or (b) of the Financial Regulation. EN 99   EN 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 si mplified 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 medici nes 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, w holesalers and importers: reduction of 
administrative burdens regarding authorisa tion of veterinary medicinal products and 
keeping them on the mark et; 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 me dicinal products authorised  
Number of applications submitted by SMEs 
Numbers of variations submitted 
Ratio of number of marketi ng authorisations for generi cs and innovative products 
Number of extensions of existing marke ting authorisation to new animal species 
Sales of antimicrobials used in  veterinary medicinal products 
Number of referrals on ve terinary 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 cu rrent legislation is disproportionate and 
burdensome, and not conducive to innovati on. This causes an overall problem 
regarding availability of veterinary me dicinal products in th e 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 EN 100   EN veterinary medicinal products . It brought some harmonisation to the procedures and 
rules required to place veterinary medicina l 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 exis tence of numerous 
national requirements imply that companies are confronted with different rules and 
interpretation in countries a nd have also led to different levels of public and animal 
health protection. It is cri tically important to have a single market for veterinary 
medicinal products  as the veterinary pharm aceutical sector is driven by commercial 
returns obtained through the sales of veteri nary medicinal products  on the resources 
spent. The current confined and fragmented markets do not allow the pharmaceutical 
sector to have a positive return on i nvestments for developing new products for 
certain animal species. The ambition to impr ove 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 sim ilar 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 im pact of the revision of the veterinary 
pharmaceutical legislation (available at ec.europa.eu/health/file s/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 w ith 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 app lication of food and 
feed law, rules on animal welfare, pl ant reproductive material, plant protection 
products, proposal for a regulation on anim al health, the Regulation (EC) No 
470/2009 for the establishment of residue limits of pharmacologically active 
substances in foodstuffs of animal orig in, Council Regulation (EC) No 297/95 on 
fees payable to the European Medicine s 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. EN 101   EN 1.6. Duration and financial impact  
 Proposal/initiative of limited duration  
–  Proposal/initiative in effect fr om [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 af ter its pub lication, 
and the date of application of th e Regulation).  During this time all 
implementation measures have to be take n 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 followe d by full-scale operation. 
1.7. Management mode(s) planned35  
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 bodi es they have designated; 
–  international organisations and th eir 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 pa rtnership 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 id entified in the relevant basic act. 
– If more than one management mode is indicated, pl ease provide details in the ‘Comments’ section. 
Comments  
                                                 
35 Details of management modes and references to the Financial Regulation may be found on the 
BudgWeb site: http://www.cc.cec/budg/man/b udgmanag/budgmanag_en.html  EN 102   EN 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 veteri nary activities. 'Veterinary Pharmaceutical 
Committee' and the co-ordina tion 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 ef fects of the new rules, the indicators as 
set out in 1.4.4 will be gathered a nd 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 th e 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 user s (authorities and mark eting authorisation 
holders). Thus, the revision of the rules w ould not provide the reduction in burden it 
intends to achieve. 
2.2.2. Information concerning the in ternal control system set up 
The competent authority of a Member Stat e has the responsibility to ensure, by 
means of inspections, that the legal requi rements 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 an d on an annual basis the required staff 
levels and resources will be reviewed. 
Close and regular contacts wi th the developers of the IT  tools should ensure that 
databases meet the requirements of users. 
2.2.3. Estimate of the costs and be nefits of the cont rols 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 Veteri nary 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.  EN 103   EN The expected level of risk of  error is low because in the current legislation Member 
States already have the same responsibilit y. 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 regulat ory control mechanisms, DG SANCO will devise 
an anti-fraud strategy in line with the Commi ssion'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 mana gement approach is geared to identify fraud 
risk areas and adequate responses. Where neces sary, networking groups and adequate IT tools 
dedicated to analysing fraud cases related to  the financing implementing activities of the 
Veterinary Medicinal Produc ts Regulation will be set up. In particular a seri es of measures 
will be put in place such as:  
- decisions, agreements and cont racts 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-th e-spot checks and inspections;  
- during the evaluation phase of a call for pr oposals/tender, the propos ers and tenderers are 
checked against the published ex clusion criteria based on declar ations 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 relate d 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. EN 104   EN 3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
3.1. Heading(s) of the multiannual financ ial framework and expenditure budget 
line(s) affected  
• Existing budget lines  
In order  of multiannual financial framewor k headings and budget lines. 
Budget line  Type of  
expenditure  Contribution  
Heading of 
multiannual 
financial 
framework  Number  
[Heading………………………...……………
] Diff./Non-
diff.36 from 
EFTA 
countries
37 
 from 
candidate 
countries38 
 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 consider ed to be fee-finan ced. Consequently, no 
additional impact is foreseen of th is proposal on the budget of the EU. 
• New budget lines requested  - NOT APPLICABLE 
In order  of multiannual financial framew ork headings and budget lines.  
Budget line  Type of  
expenditure  Contribution  
Heading of 
multiannual 
financial 
framework 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/N
O YES/NO  YES/N
O YES/NO 
                                                 
36 Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 
37 EFTA: European Free Trade Association.  
38 Candidate countries and, where applicable, poten tial candidate countries from the Western Balkans.  
EN 105   EN 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 CISN ET 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 
N39 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 
y Operational appropriations          
Commitments (1)         Number of budget line  Payments (2)         
Commitments (1a)         Number of budget line  Payments (2a)         
Appropriations of an administrative nature financed from the 
envelope of specific programmes40  
         
Number of budget line   (3)         
Commitments =1+1a 
+3         
TOTAL appropriations  
for DG <…….>  
Payments =2+2a 
+3         
                                                 
39 Year N is the year in which implem entation of the proposal/initiative starts. 
40 Technical and/or administrative assistance and expenditure in su pport of the implementation of EU programmes and/or actions (f ormer ‘BA’ lines), indirect research, 
direct research.  
EN 106   EN  
  
Commitments (4)         y TOTAL operational appropriations  
Payments (5)         
y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (6)         
Commitments =4+ 6         TOTAL appropriations  
under HEADING <….>  
of the multiannual financial framework  Payments =5+ 6         
If more than one heading is affected by the proposal / initiative:  
Commitments (4)         y TOTAL operational appropriations  
Payments (5)         
y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (6)         
Commitments =4+ 6         TOTAL appropriations  
under HEADINGS 1 to 4  
of the multiannual financial framework 
(Reference amount)  Payments =5+ 6         
  
EN 107   EN  
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: <…….> 
y Human resources          
y 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 
N41 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 
Commitments          TOTAL appropriations  
under HEADINGS 1 to 5  
of the multiannual financial framework   Payments          
                                                 
41 Year N is the year in which implem entation of the proposal/initiative starts.  
EN 108   EN 3.2.2. Estimated impact on opera tional appropriations  
– X The proposal/initiative does not requir e the use of operational appropriations  
–  The proposal/initiative requires the use of ope rational appropriations, as explained below: 
Commitment 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  
OUTPUTS  Indicate 
objectives and 
outputs  
 
Ø Type42 
 Avera
ge 
cost 
No Cost 
No Cost 
No Cost 
No Cost 
No Cost 
No Cost 
No Cost Total 
No Total 
cost 
SPECIFIC OBJECTIVE No 143…                  
-  O u t p u t                    
-  O u t p u t                    
-  O u t p u t                    
Subtotal for specific objective No 1                 
SPECIFIC OBJECTIVE No 2 ...                 
-  O u t p u t                    
Subtotal for specific objective No 2                 
TOTAL COST                  
                                                 
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)…’   
EN 109   EN 3.2.3. Estimated impact on appropriations  of an administrative nature 
3.2.3.1. Summary  
– X The proposal/initiative doe s 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 545 
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 e xpenditure of an administrative nature will be met by 
appropriations from the DG that are alread y 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 th e managing DG under the annual 
allocation procedure and in the light of budgetary constraints.
                                                 
44 Year N is the year in which implem entation 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.  
EN 110   EN 3.2.3.2. Estimated requirements of human resources 
– X The proposal/initiative does not require the use of human resources.  
–  The proposal/initiative re quires 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 Ye
ar 
N+
3 Enter 
as 
many 
years 
as 
necessa
ry to 
show 
the 
duratio
n of the 
impact 
(see 
point 
1.6) 
y 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)        
y 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)        
- at Headquarters  
        XX 01 04 yy 47 
 
- 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 th e DG who are already assigned to management of the 
action and/or have been redeployed within the DG, toge ther if necessary with any additional allocation which 
may be granted to the managing DG under the annual a llocation procedure and in the light of budgetary 
constraints. 
Description of tasks to be carried out: 
Officials and temporary staff  
External staff  
                                                 
46 AC= Contract Staff; AL = Lo cal Staff; END= Seco nded National Expert; INT = agency staff; 
JED= Junior Experts in Delegations.  
47 Sub-ceiling for external staff covered by op erational appropriations (former ‘BA’ lines).  
EN 111   EN 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 reprogr amming 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 mill ion (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          
 
  
EN 112   EN 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)  
Impact of the proposal/initiative48 
Budget revenue line: Appropriation
s available for 
the current 
financial year 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, speci fy the budget expenditure line(s) affected. 
 
Specify the method for calcula ting the impact on revenue. 
 
 
Annex: Estimate of costs and income of European Medicines Agency  
It is foreseen that the entire cost relating to vete rinary medicinal products act ivities in the European 
Medicines Agency related to the revision is recouped through fees. Cost estimations and 
calculations in this Annex are based on this principl e and, therefore, the proposal is not expected to 
have any financial impact on the budget of th e EU. The proposal empowers the Commission to 
adopt delegated acts to amend fees. This would a llow the Commission to adapt the fee structure in-
time to the agreement of European Pa rliament and Council on this proposal. 
The costs are based on a qualitative analysis of the expected change in seve n areas of activity after 
implementation of the regulation: pre-authorisation activities (e.g. scientific advice), evaluation 
activities (marketing authorisation applications) post-author isation activities (variations), arbitration 
and referral, monitoring activities (pharmacovigi lance), other specialised areas and activities 
(advice to the Commission, international coopera tion, 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, eval uation cost, scientific m eetings direct costs, 
translation costs and IT one-off costs and IT maintena nce costs, and is the balance of the anticipated 
change in costs and loss of fee income to EM A after implementation of the revised regulation. 
Salary costs do not take into account inflati on, exchange rates and additional pension costs 
(applicable from 2016 for the Agency).Evaluation cost concern the services provided by the 
National Competent Authorities (cos ts of rapporteurs' assessment ac tivities). 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 produ ct-related documents.  
                                                
 
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.  
EN 113   EN 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     
       
EN 114   EN           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