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 (Text with EEA relevance)
Date: 2004-03-31
Institutions: Council of the European Union, European Parliament
Subjects: approximation of laws, consolidation of EU law, legal code, pharmaceutical legislation, public health, single market, veterinary drug

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Official Journal of the European Union

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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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

differences with regard to the basic principles in order to
promote the operation of the internal market without
adversely affecting public health.

(Text with EEA relevance)

Having regard to the Treaty establishing the European
Community,
and in particular Article 95 and Article
152(4)(b) thereof,

(4)

Having regard to the proposal of the Commission (1),

Having regard to the Opinion of the European Economic and
Social Committee (2),

After consulting the Committee of the Regions,

Acting in accordance with the procedure referred to in Article
251 of the Treaty (3),

Whereas:

(1)

(2)

(3)

relating

Directive 2001/82/EC of the European Parliament and of
the Council of 23 October 2001 on the Community
to veterinary medicinal products (4)
code
codified and consolidated previous Community legis-
lation on veterinary medicinal products in a single text
in the interests of clarity and rationalisation.

The Community legislation so far adopted has made a
major contribution to the achievement of the objective
free and safe movement of veterinary medicinal
of
products and the elimination of obstacles to trade in
such products. However, in the light of the experience
gained,
it has become clear that new measures are
necessary to eliminate the remaining obstacles to free
movement.

It is therefore necessary to align national
lations

and administrative provisions

laws, regu-
contain

that

(1) OJ C 75 E, 26.3.2002, p. 234.
(2) OJ C 61, 14.3.2003, p. 1.
(3) Opinion of the European Parliament of 23 October 2002 (OJ C
300 E, 11.12.2003, p. 390), Council Common Position of
29 September 2003 (OJ C 297 E, 9.12.2003, p. 72), Position of
the European Parliament of 17 December 2003 (not yet published
in the Official Journal) and Council Decision of 11 March 2004.

(4) OJ L 311, 28.11.2001, p. 1.

(5)

(6)

(7)

for veterinary medicinal products,

The main purpose of any regulation on the manufacture
and distribution of veterinary medicinal products should
be to safeguard animal health and welfare as well as
public health. The legislation on marketing authoris-
ations
and the
criteria governing the granting of authorisations, are
such as to strengthen the protection of public health.
That aim should, however, be achieved by means that
do not hinder the development of the pharmaceutical
industry or trade in veterinary medicinal products within
the Community.

Article 71 of Council Regulation (EEC) No 2309/93 of
22 July 1993 laying down Community procedures for
the authorisation and supervision of medicinal products
for human and veterinary use and establishing a
European Agency for
the Evaluation of Medicinal
Products (5) provided that, within six years of its entry
into force, the Commission was required to publish a
general report on the experience acquired as a result of
the operation of the marketing authorisation procedures
laid down in that Regulation and in other Community
legal provisions.

light of

acquired,

the Commission's

report on the
In the
experience
to
improve the operation of the marketing authorisation
procedures for veterinary medicinal products in the
Community.

it has proved necessary

the quality,

Particularly as a result of scientific and technical progress
in the field of animal health, the definitions and scope of
Directive 2001/82/EC should be clarified in order to
achieve high standards
safety and
for
efficacy of veterinary medicinal products. In order to
take account both of the emergence of new therapies
and of
the growing number of so-called ‘borderline’
products between the medicinal product sector and
other
‘medicinal product’
should be modified so as to avoid any doubt as to the
applicable legislation when a product, whilst fully falling
within the definition of a medicinal product, may also
fall within the definition of other regulated products.
Also,
in view of the characteristics of pharmaceutical
legislation, provision should be made for such legislation
clarifying
to apply. With the
situations, where a given product comes under the defi-

same objective of

the definition of

sectors,

(5) OJ L 214, 24.8.1993, p. 1. Regulation repealed by Regulation (EC)

No 726/2004 (see p. 1 of this Official Journal).

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L 136/59

nition of a veterinary medicinal product, but could also
fall within the definition of other regulated products, it
is necessary, in cases of doubt and in order to ensure
legal certainty, to state explicitly which provisions have
to be complied with. Where a product comes clearly
in
under the definition of other product categories,
particular food,
this
Directive should not apply.
It is also appropriate to
improve the consistency of the terminology of phar-
maceutical legislation.

feed additives or biocides,

feed,

disagreements within the framework of a revised decen-
tralised procedure.

(13) With regard to referrals, the experience acquired reveals
the need for an appropriate procedure, particularly in
the case of referrals relating to an entire therapeutic
class or to all veterinary medicinal products containing
the same active substance.

(8)

(9)

(10)

(11)

(12)

The veterinary medicinal products sector has a number
of very specific features. Veterinary medicinal products
for food-producing animals may be authorised only on
conditions that guarantee that the foodstuffs produced
will be harmless to consumers as regards any residues of
such medicinal products.

costs of

research and development

to meet
The
increased requirements as regards the quality, safety
and efficacy of veterinary medicinal products
are
reduction in the
leading to a gradual
range of
the species and indications
products authorised for
representing smaller market sectors.

The provisions of Directive 2001/82/EC also need,
therefore, to be adapted to the specific features of the
sector, particularly to meet the health and welfare needs
of food-producing animals on terms that guarantee a
high level of consumer protection, and in a context
that provides
the
adequate
veterinary medicinal products industry.

economic

interest

for

In certain circumstances, particularly where certain types
of pets are concerned, the need to obtain a marketing
authorisation for a veterinary medicinal product
in
accordance with Community provisions is clearly dispro-
portionate. Moreover, the absence of authorisation to
market an immunological product in the Community
should not be an obstacle to international movements
of certain live animals for the purpose of which binding
health measures have to be taken. The provisions on the
authorisation or use of such medicinal products to take
account of measures to combat certain infectious animal
diseases at Community level also need to be adapted.

Evaluation of
the operation of market authorisation
procedures has revealed the need to revise, in particular,
the mutual-recognition procedure in order to improve
the opportunities
for cooperation between Member
States. This cooperation process should be formalised
by setting up a coordination group for this procedure
to settle
and by

its operation so as

defining

(14) Marketing

for

authorisation

veterinary medicinal
products should be limited initially to five years. After
this first renewal, the marketing authorisation should
normally be valid for an unlimited period. Furthermore,
any authorisation not used for three consecutive years,
that is to say, one which has not led to the placing on
the market of a veterinary medicinal product in the
Member States concerned during that period, should
be considered invalid, in order, in particular, to avoid
the administrative burden of maintaining such authoris-
ations. However, exemptions from this rule should be
granted when these are justified on public or animal
health grounds.

(15)

(16)

(17)

to manufacturing process

Biological medicinal products similar
to a reference
medicinal product do not usually meet all the conditions
to be considered as a generic medicinal product mainly
raw
due
materials used, molecular characteristics and therapeutic
modes of action. When a biological product does not
meet all the conditions to be considered as a generic
the results of appropriate tests
medicinal product,
should be provided in order to fulfil the requirements
related to safety (pre-clinical tests) or to efficacy (clinical
tests) or to both.

characteristics,

The criteria of quality, safety and efficacy should enable
the risk-benefit balance of all veterinary medicinal
products to be assessed both when they are placed on
the market and at any other
time the competent
authority deems this appropriate. In this connection, it
is necessary to harmonise and adapt
the criteria for
refusal, suspension and revocation of marketing author-
isations.

if no medicinal product has
In the veterinary sector,
a given
a given species or
been authorised for
disorder,
existing
the possibility of using other
products should be made a straightforward matter, but
without prejudicing consumer health in the case of
medicinal products intended for administration to food-
producing animals.
In particular, medicinal products
should be used only under conditions that guarantee
that
to
consumers
residues of medicinal
products.

foodstuffs produced will be harmless

regards

any

the

as

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(18)

(19)

There is also a need to stimulate the interest of the
veterinary pharmaceuticals industry in certain market
segments in order to encourage the development of
new veterinary medicinal products. The period of
administrative data-protection vis-a-vis generics should
be harmonised.

the

quality of

There is also a need to clarify the obligations of, and
division of responsibilities between, the applicant for a
marketing authorisation, the holder of a marketing auth-
orisation and the competent authorities in charge of
foodstuffs, particularly
monitoring
through compliance with the provisions on the use of
veterinary medicinal products. In addition, in order to
facilitate the testing of new medicinal products while
guaranteeing a high level of protection for consumers,
sufficiently long withdrawal periods should be laid down
for
foodstuffs that animals involved in tests might
produce.

(20) Without prejudice to the provisions aimed at guaran-
teeing consumer protection, the specific characteristics
of homeopathic veterinary medicinal products, and
particularly their use in organic farming, should be
taken into account
simplified
procedure for registration on terms defined in advance.

establishing

by

a

(21)

(22)

In order to increase the information available to users
and to improve consumer protection in the case of food-
producing animals, the provisions on the labelling of
veterinary medicinal products and the accompanying
package leaflet should be strengthened. The requirement
that a veterinary medicinal product may only be
dispensed after a veterinary prescription has been
made out should, as a general principle, be extended
to all medicinal products for food-producing animals.
However,
it should be possible to grant exemptions,
where appropriate. The administrative procedures for
supplying medicinal products for pets, on the other
hand, should be simplified.

The quality of veterinary medicinal products manu-
factured or available in the Community should be
guaranteed by requiring that the active substances used
in their composition comply with the principles of good
It has proved necessary to
manufacturing practice.
reinforce the Community provisions on inspections
and to compile a Community register of the results of
those inspections. The provisions for the official release
of batches of immunological medicinal products should
be
the
improvement of the general system for monitoring the
quality of medicinal products and to reflect technical
and scientific progress, and also in order
to make
mutual recognition fully effective.

account of

in order

reviewed

to take

(23)

(24)

(25)

environmental

studied and
The
consideration should be given on a case-by-case basis
to specific provisions seeking to limit it.

should be

impact

and, more

generally, market
Pharmacovigilance
surveillance and sanctions in the event of
failure to
comply with the provisions should be stepped up. In
the field of pharmacovigilance, account
should be
taken of the facilities offered by new information tech-
nologies to improve exchanges between Member States.

The measures necessary for the implementation of this
Directive should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down
the procedures
implementing
exercise of
for
powers conferred on the Commission (1).

the

(26) Directive 2001/82/EC should be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 2001/82/EC shall be amended as follows:

1) Article 1 shall be amended as follows:

(a) point 1 shall be deleted;

(b) point 2 shall be replaced by the following:

‘2. Veterinary medicinal product:

(a) any substance or combination of substances
presented as having properties for treating or
preventing disease in animals; or

(b) any substance or combination of substances
which may be used in or administered to
to restoring,
animals with a view either
physiological
correcting
a pharmacological,
functions by
immunological or metabolic action, or
to
making a medical diagnosis.’;

or modifying

exerting

(c) point 3 shall be deleted;

(1) OJ L 184, 17.7.1999, p. 23.

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(d) points 8, 9 and 10 shall be replaced by the following:

— any

risk of undesirable

effects on the

‘8. Homeopathic veterinary medicinal product:

called

stocks

homeopathic

Any veterinary medicinal product prepared from
substances
in
accordance with a homeopathic manufacturing
procedure described by the European Phar-
macopoeia or, in the absence thereof, by the phar-
macopoeias currently used officially in Member
States. A homeopathic
veterinary medicinal
product may contain a number of principles.

9. Withdrawal period:

the veterinary medicinal product

The period necessary between the last adminis-
tration of
to
animals, under normal conditions of use and in
accordance with the provisions of this Directive,
and the production of
from such
in order to protect public health by
animals,
ensuring that
such foodstuffs do not contain
residues in quantities in excess of the maximum
residue limits for active substances laid down
pursuant to Regulation (EEC) No 2377/90.

foodstuffs

10. Adverse reaction:

A reaction to a veterinary medicinal product
which is harmful and unintended and which
occurs at doses normally used in animals for the
prophylaxis, diagnosis or treatment of disease or
to restore, correct or modify a physiological
function.’;

(e)

the following point shall be inserted:

‘17a. Representative of the marketing authorisation holder:

person,

commonly

local
The
representative, designated by the marketing
authorisation holder to represent him in the
Member State concerned.’;

known

as

(f) point 18 shall be replaced by the following:

‘18. Agency:

The European Medicines Agency established by
Regulation (EC) No 726/2004 (*);

___________
(*) OJ L 136, 30.4.2004, p. 1.’;

(g) point 19 shall be replaced by the following:

‘19. Risks relating to use of the product:

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

environment.’;

(h) the following points shall be added:

‘20. Risk/benefit balance:

An evaluation of the positive therapeutic effects
of the veterinary medicinal product in relation to
the risks as defined above.

21. Veterinary prescription:

Any prescription for a veterinary medicinal
product
person
a
qualified to do so in accordance with applicable
national law.

professional

issued

by

22. Name of veterinary medicinal product:

The name, which may be either an invented
name not liable to confusion with the common
name, or a common or scientific name accom-
panied by a trademark or
the
marketing authorisation holder.

the name of

23. Common name:

The international non-proprietary name recom-
mended by the World Health Organisation, or,
if one does not exist, the usual common name.

24. Strength:

The content of active
substances, expressed
quantitatively per dosage unit, per unit of
volume or weight according to the dosage form.

25.

Immediate packaging:

The container or any other form of packaging
is in direct contact with the medicinal
that
product.

26. Outer packaging:

The packaging
immediate packaging.

into which is placed

the

27. Labelling:

Information
packaging.

28. Package leaflet:

on

the

immediate

or

outer

The leaflet containing information for the user
that accompanies the medicinal product.’;

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2) Articles 2 and 3 shall be replaced by the following:

‘Article 2

1.
This Directive shall apply to veterinary medicinal
products, including pre-mixes for medicated feedingstuffs,
intended to be placed on the market in Member States and
prepared industrially or by a method involving an
industrial process.

2.
In cases of doubt, where, taking into account all its
characteristics, a product may fall within the definition of
a “veterinary medicinal product” and within the definition
of a product covered by other Community legislation, the
provisions of this Directive shall apply.

Notwithstanding paragraph 1,

this Directive shall
3.
also apply to active substances used as starting materials
to the extent set out in Articles 50, 50a, 51 and 80 and
additionally to certain substances that may be used as
veterinary medicinal products that have anabolic, anti-
infectious, anti-parasitic, anti-inflammatory, hormonal or
psychotropic properties to the extent set out in Article 68.

Article 3

1.

This Directive shall not apply to:

(a) medicated feedingstuffs as defined in Council Directive
90/167/EEC of 26 March 1990 laying down the
conditions governing the preparation, placing on the
market and use of medicated feedingstuffs in the
Community (*);

(b) inactivated

immunological

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

(c) veterinary medicinal products based on radio-active

isotopes;

(d) any

by

covered

additives

Council Directive
70/524/EEC of 23 November 1970 concerning
additives in feedingstuffs (**) where they are incor-
porated in animal
feedingstuffs and supplementary
animal feedingstuffs in accordance with that Directive;
and

(e) without prejudice to Article 95, medicinal products for
veterinary use intended for research and development
trials.

However, medicated
in
subparagraph (a) may be prepared only from pre-mixes
that have been authorised under this Directive.

feedingstuffs

referred

to

for

Except

the provisions on the possession,
2.
prescription, dispensing and administration of veterinary
medicinal products, this Directive shall not apply to:

(a) any medicinal product prepared in a pharmacy in
accordance with a veterinary prescription for an indi-
vidual animal or a small group of animals, commonly
known as the magistral formula; and

(b) any medicinal product prepared in a pharmacy in
accordance with the prescriptions of a pharmacopoeia
and intended to be supplied directly to the end-user,
commonly known as the officinal formula.

___________
(*) OJ L 92, 7.4.1990, p. 42.
(**) OJ L 270, 14.12.1970, p. 1. Directive as last amended
by Regulation (EC) No 1756/2002 (OJ L 265,
3.10.2002, p. 1).’;

3) Article 4(2) shall be replaced by the following:

‘2.
In the case of veterinary medicinal products intended
solely for aquarium fish, cage birds, homing pigeons,
terrarium animals, small rodents, and ferrets and rabbits
kept exclusively as pets, Member States may permit
exemptions,
from the provisions in
Articles 5 to 8, provided that such products do not
contain substances the use of which requires veterinary
control and that all possible measures are taken to
prevent unauthorised use of
for other
animals.’;

in their territory,

the products

4) Articles 5 and 6 shall be replaced by the following:

‘Article 5

No veterinary medicinal product may be placed on
1.
the market of a Member State unless a marketing author-
isation has been granted by the competent authorities of
that Member State in accordance with this Directive or a
marketing authorisation has been granted in accordance
with Regulation (EC) No 726/2004.

in

accordance with
species,

When a veterinary medicinal product has been granted an
initial
first
authorisation
the
strengths, phar-
subparagraph, any additional
maceutical forms, administration routes, presentations, as
well as any variations and extensions, shall also be granted
an authorisation in accordance with the first subparagraph
or be included in the initial marketing authorisation. All
these marketing authorisations shall be considered as
belonging to the same global marketing authorisation, in
particular for the purpose of the application of Article
13(1).

authorisation

The marketing

2.
be
responsible for the marketing of the medicinal product.
The designation of a representative shall not relieve the
marketing authorisation holder of his legal responsibility.

holder

shall

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Article 6

1.
A veterinary medicinal product may not be the
subject of a marketing authorisation for the purpose of
administering it to one or more food-producing species
unless the pharmacologically active substances which it
contains appear in Annexes I,
to Regulation
(EEC) No 2377/90.

II or III

If an amendment to the Annexes to Regulation (EEC)
2.
No 2377/90 so warrants,
the marketing authorisation
holder or, where appropriate, the competent authorities
shall take all necessary measures to amend or revoke the
marketing authorisation within 60 days of the date on
which the amendment to the Annexes to that Regulation
was published in the Official Journal of the European Union.

the

1993

establishing

By way of derogation from paragraph 1, a veterinary
3.
medicinal product containing pharmacologically active
substances not included in Annexes I, II or III to Regu-
lation (EEC) No 2377/90 may be authorised for particular
animals of the equidae family that have been declared, in
accordance with Commission Decision 93/623/EEC of
20 October
identification
document (passport) accompanying registered equidae (*)
and Commission Decision 2000/68/EC of 22 December
1999 amending Decision 93/623/EEC and establishing
the
and
production (**), as not being intended for slaughter for
human consumption. Such veterinary medicinal products
shall neither
in
Annex IV to Regulation (EEC) No 2377/90 nor be
intended for use in the treatment of conditions, as
detailed in the authorised Summary of Product Charac-
teristics, for which a veterinary medicinal product is auth-
orised for animals of the equidae family.

include active substances that appear

identification

breeding

equidae

for

of

that

health rules, a Member State may permit the use, for the
in question, of an immunological veterinary
animal
medicinal product
is not covered by a marketing
authorisation in the Member State in question but is auth-
orised under the legislation of the third country. Member
States shall take all appropriate measures concerning the
supervision of the importation and the use of such immu-
nological products.’;

6) Articles 10 to 13 shall be replaced by the following:

‘Article 10

1. Member States shall take the necessary measures to
ensure that, if there is no authorised veterinary medicinal
product in a Member State for a condition affecting a non
food-producing species, by way of exception, the veter-
inarian responsible may, under his/her direct personal
responsibility and in particular to avoid causing unac-
ceptable suffering, treat the animal concerned with:

(a) a veterinary medicinal product authorised in the
Member State concerned under
this Directive or
under Regulation (EC) No 726/2004 for use with
another animal species, or for another condition in
the same species; or

(b) if there is no product as referred to in point (a), either:

(i) a medicinal product authorised for human use in
the Member State concerned in accordance with
Directive 2001/83/EC of the European Parliament
and of
the Council or under Regulation (EC)
No 726/2004, or

___________
(*) OJ L 298, 3.12.1993, p. 45. Decision as amended by
23,

2000/68/EC (OJ

L

Commission Decision
28.1.2000, p. 72).

(**) OJ L 23, 28.1.2000, p. 72.’;

5) Article 8 shall be replaced by the following:

‘Article 8

(c)

In the event of serious epizootic diseases, Member States
may provisionally allow the use of
immunological
veterinary medicinal products without a marketing auth-
orisation, in the absence of a suitable medicinal product
and after
the detailed
conditions of use.

informing the Commission of

The Commission may avail itself of the option set out in
the first paragraph when explicit provision is made for
that option under Community rules concerning certain
serious epizootic diseases.

If an animal
is being imported from, or exported to, a
third country and is thereby subject to specific binding

(ii) in accordance with specific national measures, a
veterinary medicinal
in
another Member State in accordance with this
in
Directive for use in the same species or
another species for the condition in question or
for another condition; or

authorised

product

concerned,

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

a

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

2.
By way of derogation from Article 11, the provisions
of paragraph 1 of this Article shall also apply to the
treatment by a veterinarian of an animal belonging to
the equidae family provided that it has been declared, in
accordance with Commission Decisions 93/623/EEC and
2000/68/EC, as not being intended for slaughter
for
human consumption.

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By way of derogation from Article 11, and in
3.
accordance with the procedure referred to in Article
89(2), the Commission shall establish a list of substances
essential for the treatment of equidae and for which the
less than six months
withdrawal period shall be not
according to the control mechanisms
laid down in
Commission Decisions 93/623/EEC and 2000/68/EC.

— 7 days for eggs,

— 7 days for milk,

— 28 days for meat from poultry and mammals including

fat and offal,

Article 11

— 500 degree-days for fish meat.

1. Member States shall take the necessary measures to
ensure that, if there is no authorised veterinary medicinal
product in a Member State for a condition affecting a
food-producing species, by way of exception, the veter-
inarian responsible may, under his direct personal respon-
sibility and in particular to avoid causing unacceptable
the animals concerned on a particular
suffering,
holding with:

treat

(a) a veterinary medicinal product authorised in the
this Directive or
Member State concerned under
under Regulation (EC) No 726/2004 for use with
another animal species, or for another condition in
the same species; or

(b) if there is no product as referred to in point (a), either:

(i) a medicinal product for human use authorised in
the Member State concerned in accordance with
Directive 2001/83/EC or under Regulation (EC)
No 726/2004, or

(ii) a veterinary medicinal product

authorised in
another Member State in accordance with this
Directive for use in the same species or
in
another food-producing species for the condition
in question or for another condition; or

(c)

concerned,

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

a

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

Paragraph 1 shall apply provided that pharmaco-
2.
included in the medicinal
logically active substances
product are listed in Annex I,
to Regulation
(EEC) No 2377/90, and that the veterinarian specifies an
appropriate withdrawal period.

II or III

Unless the medicinal product used indicates a withdrawal
period for the species concerned, the specified withdrawal
period shall not be less than:

these

However,
specific withdrawal periods may be
modified in accordance with the procedure referred to in
Article 89(2).

3. With regard to homeopathic veterinary medicinal
products in which active principles figure in Annex II to
Regulation (EEC) No 2377/90,
the withdrawal period
referred to in the second subparagraph of paragraph 2
shall be reduced to zero.

the date of examination of

4. When a veterinarian has recourse to the provisions
this Article, he shall keep
of paragraphs 1 and 2 of
adequate records of
the
the number of animals
animals, details of
treated, the diagnosis, the medicinal products prescribed,
the doses administered, the duration of treatment and the
withdrawal periods recommended, and shall make these
records available for inspection by the competent auth-
orities for a period of at least five years.

the owner,

States

5. Without prejudice to the other provisions of this
all necessary
Directive, Member
measures concerning the import, distribution, dispensing
of and information on the medicinal products which they
permit for administration to food-producing animals in
accordance with paragraph 1(b)(ii).

shall

take

Article 12

1.
For the purposes of obtaining a marketing author-
isation in respect of a veterinary medicinal product,
otherwise than under the procedure established by Regu-
lation (EC) No 726/2004, an application shall be lodged
the Member State
with the competent authority of
concerned.

In the case of veterinary medicinal products which are
intended for one or more food-producing species but
whose pharmacologically active substances have not yet
been included, for the species in question, in Annexes I,
II or III to Regulation (EEC) No 2377/90, a marketing
authorisation may not be applied for until after a valid
application has been made for
the establishment of
maximum residue limits in accordance with that Regu-
lation. At least six months shall elapse between a valid
application for the establishment of maximum residue
limits and an application for a marketing authorisation.

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in the case of veterinary medicinal products
However,
referred to in Article 6(3), a marketing authorisation
may be applied for without a valid application in
accordance with Regulation (EEC) No 2377/90. All the
scientific documentation necessary for the demonstration
of
the veterinary
safety and efficacy of
medicinal product, as provided for in paragraph 3, shall
be submitted.

the quality,

A marketing authorisation may only be granted to

2.
an applicant established in the Community.

3.
The application for marketing authorisation shall
include all the administrative information and scientific
documentation necessary for demonstrating the quality,
safety and efficacy of the veterinary medicinal product in
question. The file shall be submitted in accordance with
Annex I and shall contain,
the following
information:

in particular,

(a) name or business name and permanent address or
registered place of business of the person responsible
if
for placing the product on the market and,
different, of
the manufacturer or manufacturers
involved and of the sites of manufacture;

(b) name of veterinary medicinal product;

— safety tests and residue tests,

— pre-clinical and clinical trials;

— tests assessing the potential risks posed by the
medicinal product
the environment. This
for
impact shall be studied and consideration shall
be given on a case-by-case basis
to specific
provisions seeking to limit it.

(k) a detailed description of

the pharmacovigilance
system and, where appropriate, the risk management
system that the applicant will put in place;

(l)

a summary in accordance with Article 14 of
the
product characteristics, a mock-up of the immediate
packaging and the outer packaging of the veterinary
medicinal product, together with the package leaflet,
in accordance with Articles 58 to 61;

(m) a document showing that the manufacturer is auth-
orised in his own country to produce veterinary
medicinal products;

(c) qualitative and quantitative particulars of all

the
the veterinary medicinal product,
constituents of
including
international non-proprietary name
(INN) recommended by the WHO, where an INN
exists, or its chemical name;

its

(d) description of the method of manufacture;

(e)

(f)

(g)

therapeutic indications, contra-indications and adverse
reactions;

dosage for the various species of animal for which the
its phar-
veterinary medicinal product
maceutical form, method and route of administration
and proposed shelf life;

is intended,

reasons for any precautionary and safety measures to
be taken when storing the veterinary medicinal
product, administering it
to animals and disposing
together with an indication of potential
of waste,
the veterinary medicinal product might
risks that
to human and animal
pose to the environment,
health and to plants;

(h)

indication of the withdrawal period in the case of
food-producing
medicinal products
species;

intended for

(i)

description of the testing methods employed by the
manufacturer;

(j)

results of:

— pharmaceutical

(physico-chemical, biological or

microbiological) tests,

is under

examination. Copies of

(n) copies of any marketing authorisation obtained in
another Member State or in a third country for the
relevant veterinary medicinal product, together with a
list of those Member States in which an application
for authorisation submitted in accordance with this
Directive
the
summary of the product characteristics proposed by
in accordance with Article 14 or
the applicant
approved by
the
competent
the
Member State in accordance with Article 25 and
copies of the package insert proposed, details of any
decision to refuse authorisation, whether
in the
Community or a third country and the reasons for
that decision. All this information shall be updated
on a regular basis;

authority of

(o) proof that the applicant has the services of a qualified
person responsible for pharmacovigilance and has the
necessary means for the notification of any adverse
reaction suspected of occurring
in the
Community or in a third country;

either

(p)

species

food-producing

in the case of veterinary medicinal products intended
for one or more
and
containing one or more pharmacologically active
substances not yet
in
included,
question, in Annexes I, II or III to Regulation (EEC)
No 2377/90, a document certifying that a valid
application for
establishment of maximum
residue limits has been submitted to the Agency in
accordance with the aforementioned Regulation.

the species

the

for

The documents and particulars relating to the results of
the tests referred to in point (j) of the first subparagraph
shall be accompanied by detailed and critical summaries,
drawn up as specified in Article 15.

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Article 13

By way of derogation from point

1.
(j) of the first
subparagraph of Article 12(3), and without prejudice to
industrial and
the law relating to the protection of
commercial property, the applicant shall not be required
to provide the results of the safety and residue tests or of
the pre-clinical and clinical trials if he can demonstrate
that the medicinal product is a generic of a reference
medicinal product which is or has been authorised under
Article 5 for not less than eight years in a Member State or
the Community.

veterinary medicinal product

authorised
A generic
pursuant
to this provision shall not be placed on the
market until ten years have elapsed from the initial auth-
orisation of the reference product.

The first subparagraph shall also apply when the reference
medicinal product was not authorised in the Member State
in which the application for the generic medicinal product
is submitted. In this case, the applicant shall indicate in the
application the Member State in which the reference
medicinal product
the
request of the competent authority of the Member State
the competent
in which the application is submitted,
transmit,
authority of
within a period of one month, confirmation that
the
is or has been authorised
reference medicinal product
together with the full composition of
the reference
product and if necessary other relevant documentation.

is or has been authorised. At

the other Member State shall

However, the ten-year period provided for in the second
subparagraph shall be extended to 13 years in the case of
veterinary medicinal products for fish or bees or other
species designated in accordance with the procedure
referred to in Article 89(2).

2.

For the purposes of this Article:

(a) “reference medicinal product” shall mean a product
authorised within the meaning of Article 5 in
accordance with the provisions of Article 12;

the

form as

and whose

bioequivalence with

(b) “generic medicinal product” shall mean a medicinal
product which has the same qualitative and quanti-
tative composition in active substances and the same
reference medicinal
pharmaceutical
product,
the
reference medicinal product has been demonstrated
by appropriate bioavailability studies. The different
salts, esters, ethers,
isomers,
complexes or derivatives of an active substance shall
be considered to be the same active substance, unless
they differ significantly in properties with regard to
safety and/or
additional
information intended to provide proof of the safety
and/or efficacy of the various salts, esters or derivatives
of an authorised active substance must be supplied by
the applicant. The various immediate-release oral phar-

isomers, mixtures of

In such cases,

efficacy.

maceutical forms shall be considered to be one and the
same pharmaceutical form. Bioavailability studies need
not be required of the applicant if he can demonstrate
that the generic medicinal product meets the relevant
detailed
in the
as
criteria
guidelines.

appropriate

defined

3.
In cases where the veterinary medicinal product does
not fall under the definition of a generic medicinal product
set out in paragraph 2(b) or where bio-equivalence cannot
be demonstrated through bioavailability studies or in the
case of changes to the active substance(s), therapeutic indi-
cations, strength, pharmaceutical form or route of admin-
the
istration vis-à-vis the reference medicinal product,
results of
the appropriate safety and residue tests and
pre-clinical tests or clinical trials shall be provided.

similar

4. Where a biological veterinary medicinal product
which is
to a reference biological veterinary
medicinal product does not meet the conditions in the
in
definition of generic medicinal products, owing to,
in
particular, differences relating to raw materials or
manufacturing processes of
the biological veterinary
medicinal product and the reference biological veterinary
medicinal product, the results of appropriate pre-clinical
tests or clinical trials relating to these conditions must be
provided. The type and quantity of supplementary data to
be provided must comply with the relevant criteria stated
in Annex I and the related detailed guidelines. The results
of other tests and trials from the reference medicinal
product's dossier shall not be provided.

5.
In the case of veterinary medicinal products intended
for one or more food-producing species and containing a
new active substance that has not been authorised in the
Community by 30 April 2004 the ten-year period
provided for in the second subparagraph of paragraph 1
shall be extended by one year for each extension of the
food-producing
to
marketing
species, if it is authorised within the five years following
the granting of the initial marketing authorisation.

authorisation

another

This period shall not, however, exceed a total of 13 years,
for a marketing authorisation for four or more food-
producing species.

The extension of the ten-year period to 11, 12, or 13
years for a veterinary medicinal product intended for food-
producing species shall be granted only if the marketing
authorisation holder also originally applied for deter-
mination of the maximum residue limits established for
the species covered by the authorisation.

Conducting the necessary studies,

tests and trials
6.
with a view to the application of paragraphs 1 to 5 and
shall not be
the consequential practical
regarded as
to
supplementary-protection
for medicinal
products.’;

contrary to patent-related rights or
certificates

requirements

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7) the following Articles shall be inserted:

Article 13d

‘Article 13a

By way of derogation from point

1.
(j) of the first
subparagraph of Article 12(3), and without prejudice to
the law on the protection of industrial and commercial
property, the applicant shall not be required to provide
the results of safety and residue tests or of pre-clinical tests
or clinical
the active
trials if he can demonstrate that
substances of the veterinary medicinal product have been
in well-established veterinary use within the Community
for at least ten years, with recognised efficacy and an
acceptable level of safety in terms of the conditions set
out in Annex I. In that event, the applicant shall provide
appropriate scientific literature.

2.
The assessment report published by the Agency
following the evaluation of an application for the estab-
lishment of maximum residue limits in accordance with
Regulation (EEC) No 2377/90 may be used in an appro-
priate manner as literature, particularly for the safety tests.

3.
If an applicant makes use of scientific literature to
obtain authorisation for a food-producing species, and
submits,
in respect of the same medicinal product and
with a view to obtaining authorisation for another food-
producing species, new residue studies in accordance with
Regulation (EEC) No 2377/90,
together with further
clinical trials, it shall not be permissible for a third party
to use such studies or such trials pursuant to Article 13,
for a period of three years from the grant of the author-
isation for which they were carried out.

the

(j) of

respect

By way of derogation from point
first
subparagraph of Article 12(3), and in exceptional circum-
veterinary
stances with
medicinal products, the applicant shall not be required
to provide the results of certain field trials on the target
species if
for duly
these trials cannot be carried out
substantiated reasons,
in particular on account of other
Community provisions.’;

immunological

to

8) Articles 14 to 16 shall be replaced by the following:

‘Article 14

The summary of the product characteristics shall contain,
in the order indicated below, the following information:

1) name of the veterinary medicinal product followed by

the strength and the pharmaceutical form;

2) qualitative and quantitative composition in terms of
the active substances and constituents of the excipient,
knowledge of which is essential for proper adminis-
tration of the medicinal product. The usual common
name or chemical description shall be used;

3) pharmaceutical form;

4) clinical particulars:

4.1.

target species,

4.2.

indications for use, specifying the target species,

Article 13b

4.3.

contra-indications,

In the case of veterinary medicinal products containing
active substances used in the composition of authorised
veterinary medicinal products but not hitherto used in
combination for
the results of
therapeutic purposes,
safety and residue tests, if necessary, and new pre-clinical
tests or new clinical trials relating to that combination
shall be provided in accordance with point (j) of the first
subparagraph of Article 12(3), but it shall not be necessary
to provide scientific references relating to each individual
active substance.

Article 13c

the pharmaceutical,

After the marketing authorisation has been granted, the
marketing authorisation holder may allow use to be
made of
residues,
pre-clinical and clinical documentation contained in the
file for the veterinary medicinal product with a view to
examining a subsequent application for a veterinary
medicinal product having the same qualitative and quanti-
tative composition in active substances and the same phar-
maceutical form.

safety

and

4.4.

special warnings for each target species,

4.5.

special precautions for use,
including special
precautions to be taken by the person adminis-
tering the medicinal product to the animals,

4.6.

adverse reactions (frequency and seriousness),

4.7.

use during pregnancy, lactation or lay,

4.8.

interaction with other medicinal products and
other forms of interaction,

4.9.

amounts to be administered and administration
route,

4.10. overdose (symptoms, emergency procedures,

antidotes), if necessary,

4.11. withdrawal periods for the various foodstuffs,
for which the withdrawal

including those
period is zero;

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5) pharmacological properties:

Article 16

5.1. pharmacodynamic properties,

5.2. pharmacokinetic particulars;

6) pharmaceutical particulars:

6.1.

list of excipients,

6.2. major incompatibilities,

shall

States

ensure

1. Member
that homeopathic
veterinary medicinal products manufactured and placed
on the market within the Community are registered or
authorised in accordance with Articles 17, 18 and 19,
except where such veterinary medicinal products are
covered by a registration or authorisation granted in
accordance with national
legislation on or before
case of homeopathic
In the
31 December 1993.
medicinal products registered in accordance with Article
17, Article 32 and Article 33(1) to (3) shall apply.

6.3.

shelf life, when necessary after reconstitution of
the medicinal product or when the immediate
packaging is opened for the first time,

2. Member States shall establish a simplified registration
procedure
the homeopathic veterinary medicinal
products referred to in Article 17.

for

6.4.

special precautions for storage,

6.5. nature

and

composition

of

immediate

packaging,

6.6.

special precautions for the disposal of unused
or waste
veterinary medicinal
materials derived from the use of
such
products, if appropriate;

products

7) marketing authorisation holder;

8) marketing authorisation number(s);

9) date of the first authorisation or date of renewal of

the authorisation;

3.
By way of derogation from Article 10, homeopathic
veterinary medicinal products may be administered to
non-food producing animals under the responsibility of a
veterinarian.

the

4.
By way of derogation from Article 11(1) and (2),
Member States shall permit the administration of homeo-
pathic veterinary medicinal products intended for food-
constituents of which
active
producing species
appear in Annex II
to Regulation (EEC) No 2377/90
under the responsibility of a veterinarian. Member States
shall
the use of
veterinary homeopathic medicinal products registered or
authorised in another Member State in accordance with
this Directive for use in the same species.’;

take appropriate measures to control

10) date of revision of the text.

9) Article 17 shall be amended as follows:

those parts of

the
For authorisation under Article 13,
the reference
summary of product characteristics of
referring to indications or dosage
medicinal product
forms which were still covered by patent law at the time
when a generic medicine was marketed need not be
included.

Article 15

1.
Applicants shall ensure that the detailed and critical
summaries referred to in the second subparagraph of
Article 12(3) are drafted and signed by persons with the
requisite technical or professional qualifications, set out in
a brief curriculum vitae, before being submitted to the
competent authorities.

Persons with the technical or professional qualifi-
justify any use
the scientific literature referred to in Article
in

2.
cations referred to in paragraph 1 shall
made of
13a(1)
Annex I.

in accordance with the conditions set out

3.
A brief curriculum vitae of the persons referred to in
paragraph 1 shall be appended to the detailed critical
summaries.

(a) paragraph 1 shall be replaced by the following:

‘1. Without prejudice to the provisions of Regu-
lation (EEC) No 2377/90 on the establishment of
maximum residue limits of pharmacologically active
substances intended for food-producing animals, only
homeopathic veterinary medicinal products which
satisfy all of the following conditions may be subject
to a special, simplified registration procedure:

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

in the

(b) no specific therapeutic indication appears on the
labelling of the veterinary medicinal product or in
any information relating thereto;

(c)

there is a sufficient degree of dilution to guarantee
the safety of the medicinal product. In particular,
the medicinal product shall not contain more than
one part per 10 000 of the mother tincture.

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If it appears justified in the light of new scientific
evidence, points (b) and (c) of the first subparagraph
may be adapted in accordance with the procedure
referred to in Article 89(2).

2. Where a Member State notes that another marketing
authorisation application for the same medicinal product
is being examined in another Member State, the Member
State concerned shall decline to assess the application and
shall advise the applicant that Articles 31 to 43 apply.

the time of

At
shall
determine the classification for the dispensing of the
medicinal product.’;

registration, Member States

(b) paragraph 3 shall be deleted;

10) Article 18 shall be amended as follows:

(a) the third indent shall be replaced by the following:

‘— manufacturing and control

file for each phar-
maceutical form and a description of the method
of dilution and potentisation,’;

(b) the sixth indent shall be replaced by the following:

‘— one or more mock-ups of the outer packaging and
immediate packaging of the medicinal products to
be registered,’;

(c) the following eighth indent shall be added:

‘— proposed withdrawal period together with all

requisite justification.’;

11) Article 19 shall be replaced by the following:

‘Article 19

1.
Homeopathic veterinary medicinal products other
than those referred to in Article 17(1) shall be authorised
in accordance with Articles 12, 13a, 13b, 13c, 13d and
14.

A Member State may introduce or retain on its
2.
territory specific rules for the safety tests and pre-clinical
and clinical
trials of homeopathic veterinary medicinal
products intended for pet species and non-food-producing
exotic species other than those referred to in Article 17(1),
in accordance with the principles and characteristics of
homeopathy as practised in that Member State. In this
case,
concerned shall notify the
Commission of the specific rules in force.’;

the Member State

12) Articles 21, 22 and 23 shall be replaced by the following:

‘Article 21

1. Member States shall take all appropriate measures to
ensure that the procedure for granting a marketing auth-
orisation for a veterinary medicinal product is completed
within a maximum of 210 days after the submission of a
valid application.

Applications for marketing authorisations for the same
veterinary medicinal product
in two or more Member
States, shall be submitted in accordance with Articles 31
to 43.

Article 22

Where a Member State is informed,
in accordance with
point (n) of Article 12(3), that another Member State has
authorised a veterinary medicinal product which is the
subject of
authorisation in the
Member State concerned, that Member State shall reject
the application unless it was submitted in compliance
with Articles 31 to 43.

an application for

Article 23

In order to examine the application submitted pursuant to
Articles 12 to 13d, Member States' competent authorities:

1) shall check that

the documentation submitted in
support of the application complies with Articles 12
to 13d and ascertain whether the conditions for the
issue of the marketing authorisation have been fulfilled;

for

testing by

2) may submit the medicinal product, its starting materials
and if necessary intermediate products or other
an Official
constituent materials
Medicines Control Laboratory or a laboratory that a
Member State has designated for
in
order to ensure that the testing methods employed by
the manufacturer and described in the application
in accordance with point (i) of the first
documents,
subparagraph of Article 12(3), are satisfactory;

that purpose,

3) may similarly check, in particular through consultation
of a national or Community reference laboratory, that
the analytical method used for detecting residues
presented by the applicant for the purposes of Article
12(3)(j), second indent is satisfactory;

4) may, where appropriate,

require the applicant

to
provide further information as regards the items listed
in Articles 12, 13a, 13b, 13c and 13d. Where the
competent authorities take this course of action, the
time-limits specified in Article 21 shall be suspended
until
the further data required have been provided.
Similarly, these time-limits shall be suspended for any
period which the applicant may be given to provide
oral or written explanations.’;

13) Article 25 shall be replaced by the following:

‘Article 25

the
1. When granting a marketing authorisation,
competent authority shall
the
inform the holder of
summary of product characteristics that it has approved.

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to ensure that

The competent authority shall

take all necessary
2.
information concerning the
measures
the
and in particular
veterinary medicinal product,
labelling and package leaflet,
is in conformity with the
summary of product characteristics approved when the
marketing authorisation was granted or subsequently.

The competent authority shall make the marketing
3.
together
authorisation publicly available without delay,
with the summary of product characteristics for each
veterinary medicinal product that it has authorised.

The

shall

draw up

competent

an
authority
4.
assessment report and comments on the file as regards
the results of the pharmaceutical, safety and residue tests
and the pre-clinical and clinical trials of the veterinary
medicinal product
report
shall be updated whenever new information becomes
available which is of importance for the evaluation of
the quality, safety or efficacy of the veterinary medicinal
product concerned.

concerned. The assessment

15) Article 27 shall be amended as follows:

(a) paragraphs 2 and 3 shall be replaced by the following:

The

competent

authority may

‘2.
the
applicant or the marketing authorisation holder to
to
provide sufficient quantities of
enable controls to be made on the identification of
the presence of residues of the veterinary medicinal
products in question.

the substances

require

to facilitate

shall provide his
the

At the competent authority's request, the marketing
technical
authorisation holder
the
expertise
implementation of
the
analytical method for detecting residues of
national
veterinary medicinal
reference
Council
laboratory
Directive 96/23/EC of 29 April 1996 on measures to
monitor certain substances and residues thereof in live
animals and animal products (*).

products
designated

the
under

in

The competent authority shall make the assessment report
and its reasons for the opinion publicly available without
delay, after deleting any information of a commercially
confidential nature.’;

14) Article 26 shall be amended as follows:

(a) paragraph 1 shall be replaced by the following:

is

the

latter

required,

to indicate on the

‘1.
The marketing authorisation may require the
immediate packaging
holder
and/or the outer wrapping and the package leaflet,
other particulars
where
essential
including
for safety or health protection,
any special precautions relating to use and any other
warnings resulting from the clinical and pharmaco-
logical
trials prescribed in Article 12(3)(j) and in
Articles 13 to 13d or from experience gained during
the use of the veterinary medicinal product once it has
been marketed.’.

(b) paragraph 2 shall be deleted;

(c) paragraph 3 shall be replaced by the following:

circumstances,

In exceptional

to a requirement

and following
‘3.
the authorisation
consultation with the applicant,
may be granted subject
for the
applicant to introduce specific procedures, in particular
concerning the safety of
the veterinary medicinal
product, notification to the competent authorities of
any incident relating to its use, and action to be taken.
Such authorisations may be granted only for objective,
verifiable reasons. Continuation of the authorisation
shall be linked to the annual reassessment of these
conditions.’;

the

The

competent

authorisation holder

immediately
3.
authority with any new
supply
information that might entail the amendment of the
particulars or documents referred to in Articles 12(3),
13, 13a, 13b and 14 or Annex I.

shall

shall

immediately

In particular, he
inform the
competent authority of any prohibition or restriction
imposed by the competent authorities of any country
in which the veterinary medicinal product is placed on
the market and of any other new information which
might
influence the assessment of the benefits and
risks of the veterinary medicinal product concerned.

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

the

___________
(*) OJ L 125, 23.5.1996, p. 10. Directive as amended
by Regulation (EC) No 806/2003 (OJ L 122,
16.5.2003, p. 1).’;

(b) paragraph 4 shall be deleted;

(c) paragraph 5 shall be replaced by the following:

authorisation

The marketing

‘5.
shall
immediately inform the competent authorities, with a
view to authorisation, of any alteration which he
proposes to make to the particulars or documents
referred to in Articles 12 to 13d.’;

holder

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16) the following Article shall be inserted:

‘Article 27a

the
After a marketing authorisation has been granted,
holder of the authorisation shall
inform the competent
authority of the authorising Member State of the date of
the veterinary
the actual placing on the market of
medicinal product
taking into
in that Member State,
account the various presentations authorised.

The holder shall also notify the competent authority if the
product ceases to be placed on the market of the Member
State, either temporarily or permanently. Such notification
shall, otherwise than in exceptional circumstances, be
made no less than two months before the interruption
in the placing on the market of the product.

Upon request by the competent authority, particularly in
the context of pharmacovigilance, the marketing author-
isation holder shall provide the competent authority with
all data relating to the volume of sales of the veterinary
medicinal product, and any data in his possession relating
to the volume of prescriptions.’;

17) Article 28 shall be replaced by the following:

‘Article 28

1. Without prejudice
marketing authorisation shall be valid for five years.

to paragraphs 4 and 5,

a

The authorisation may be renewed after five years on

2.
the basis of a re-evaluation of the risk-benefit balance.

safety and efficacy,

To this end,
the marketing authorisation holder shall
submit a consolidated list of all documents submitted in
including all
respect of quality,
variations introduced since the marketing authorisation
was granted, at least six months before the marketing
authorisation ceases
to be valid in accordance with
paragraph 1. The competent authority may require the
applicant to submit the listed documents at any time.

3.
Once renewed, the marketing authorisation shall be
the competent
valid for an unlimited period, unless
authority decides, on justified grounds relating to phar-
macovigilance, to proceed with one additional five-year
renewal in accordance with paragraph 2.

5. When an authorised veterinary medicinal product
previously placed on the market
in the authorising
Member State is no longer actually present on the
three
in that Member State for a period of
market
that
the authorisation granted for
consecutive years,
veterinary medicinal product shall cease to be valid.

6.
The competent authority may, in exceptional circum-
stances, and on human or animal health grounds, grant
exemptions from paragraphs 4 and 5. Such exemptions
shall be duly justified.’;

18) Article 30 shall be replaced by the following:

‘Article 30

The marketing authorisation shall be refused if the file
submitted to the competent authorities does not comply
with Articles 12 to 13d and Article 15.

The authorisation shall also be refused if, after exam-
ination of
listed in
the documents and particulars
Articles 12 and 13(1), it is clear that:

(a) the risk-benefit balance of

the veterinary medicinal
product is, under the authorised conditions of use,
unfavourable; when the
a
for zootechnical use,
veterinary medicinal product
particular
regard shall be had to the benefits for
animal health and welfare and to consumer safety; or

application concerns

(b) the product has no therapeutic effect or the applicant
has not provided sufficient proof of such effect as
regards the species of animal which is to be treated; or

(c)

its qualitative or quantitative composition is not as
stated; or

(d) the withdrawal period recommended by the applicant
is not long enough to ensure that foodstuffs obtained
from the treated animal do not contain residues which
might constitute a health hazard to the consumer, or is
insufficiently substantiated; or

(e) the labelling or the package leaflet proposed by the
applicant does not comply with this Directive; or

(f)

the veterinary medicinal product is offered for sale for
a use prohibited under other Community provisions.

4.
Any authorisation that is not followed within three
years of its granting by the actual placing on the market of
the authorised veterinary medicinal product in the auth-
orising Member State shall cease to be valid.

However, when a Community legislative framework is in
the course of being adopted, the competent authority may
refuse authorisation for a veterinary medicinal product
where such action is necessary for the protection of
public health, consumer or animal health.

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The applicant or marketing authorisation holder shall be
responsible for
the accuracy of documents and data
submitted.’;

19) the title of Chapter 4 shall be replaced by the following:

‘CHAPTER 4

Mutual
procedure’;

recognition procedure

and decentralised

20) Articles 31 to 37 shall be replaced by the following:

‘Article 31

A coordination group shall be set up for the exam-
1.
ination of any question relating to marketing authorisation
of a veterinary medicinal product in two or more Member
States in accordance with the procedures laid down in this
Chapter. The Agency shall provide the secretariat of this
coordination group.

2.
The coordination group shall be composed of one
representative per Member State appointed for a renewable
period of three years. Members of the group may arrange
to be accompanied by experts.

The coordination group shall draw up its own rules
3.
of procedure, which shall enter
into force after a
favourable opinion has been given by the Commission.
These rules of procedure shall be made public.

Article 32

the

applicant

1. With a view to the granting of a marketing author-
isation for a veterinary medicinal product in more than
an
one Member State,
application based on an identical dossier
in those
Member States. The dossier shall contain all the adminis-
trative information and scientific and technical documen-
tation described in Articles 12 to 14. The documents
submitted
States
a
shall
concerned by the application.

list of Member

include

submit

shall

The applicant shall request one Member State to act as
reference Member State and to prepare an assessment
report in respect of the veterinary medicinal product in
accordance with paragraphs 2 or 3.

Member State. To this end, the marketing authorisation
holder shall request the reference Member State either to
prepare an assessment report in respect of the veterinary
medicinal product or, if necessary, to update any existing
report. The reference Member State shall
assessment
prepare or update the assessment report within 90 days
of receipt of a valid application. The assessment report
together with the approved summary of product charac-
teristics, labelling and package leaflet shall be forwarded to
the concerned Member States and the applicant.

If the veterinary medicinal product has not received
3.
the applicant
authorisation by the time of application,
the reference Member State to prepare a
shall request
the summary of
draft assessment report and drafts of
product characteristics,
labelling and package leaflet. The
reference Member State shall prepare these drafts within
120 days of the receipt of a valid application and shall
send them to the concerned Member States and the
applicant.

receipt of

the documents
4. Within 90 days after
referred to in paragraphs 2 and 3, the Member States
concerned shall approve
the
the
summary of product characteristics, the labelling and the
package leaflet and inform the reference Member State
accordingly. The reference Member State shall record the
agreement of all parties, close the procedure and inform
the applicant accordingly.

assessment

report,

State

Each Member

5.
in which an application
following paragraph 1 has been submitted shall adopt a
decision in conformity with the approved assessment
labelling and
report, summary of product characteristics,
package leaflet within 30 days after acknowledgement of
the agreement.

Article 33

of

product

characteristics,

If a Member State cannot, within the period allowed
1.
report,
in Article 32(4), agree with the assessment
summary
and
package leaflet on grounds of a potential serious risk to
human or animal health or to the environment, a detailed
statement of the reasons shall be provided to the reference
Member State, the other Member States concerned and the
applicant. The points of disagreement shall be referred
without delay to the coordination group.

labelling

Where appropriate, the assessment report shall contain an
evaluation for the purposes of Article 13(5) or Article
13a(3).

If a Member State to which an application has been
submitted invokes
referred to in Article
71(1), it shall no longer be regarded as a Member State
concerned by this Chapter.

the reasons

If

the veterinary medicinal product has already
2.
received a marketing authorisation at
time of
application, the concerned Member States shall recognise
the marketing authorisation granted by the reference

the

2.
The Commission shall adopt guidelines defining a
potential serious risk for human or animal health or for
the environment.

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3. Within the coordination group, all Member States
referred to in paragraph 1 shall use their best endeavours
to reach agreement on the action to be taken. They shall
provide the applicant with the opportunity to make his
point of view known orally or in writing. If, within 60
days
for
of
disagreement
to the coordination group the Member
States reach an agreement, the reference Member State
shall
record the agreement, close the procedure and
inform the applicant accordingly. Article 32(5) shall apply.

communication

reasons

the

the

of

the Agency

If within the period of 60 days the Member States
4.
fail
shall be
to reach an agreement,
immediately informed with a view to application of the
procedure laid down in Articles 36, 37 and 38. The
Agency shall be provided with a detailed description of
the matters on which agreement could not be reached
and the reasons for the disagreement. The applicant shall
be provided with a copy of this information.

5.
As soon as the applicant has been informed that the
matter has been referred to the Agency, he shall forthwith
forward to the Agency a copy of the information and
documents
subparagraph of
Article 32(1).

referred to in the first

6.
In the case referred to in paragraph 4, the Member
States that have approved the assessment report, summary
of product characteristics, labelling and package leaflet of
the reference Member State may, on request by the
the
applicant,
authorisation for
a marketing
the
veterinary medicinal product without waiting for
outcome of the procedure laid down in Article 36.
In
that case,
the authorisation granted shall be without
prejudice to the outcome of that procedure.

grant

Article 34

a

1.
If two or more applications submitted in accordance
with Articles 12 to 14 have been made for marketing
veterinary medicinal
particular
authorisation for
product and Member States have adopted divergent
decisions concerning the authorisation of that veterinary
medicinal product, or suspension or revocation of author-
isation, a Member State, or
the
marketing-authorisation holder may refer the matter to
the Committee for Medicinal Products
for Veterinary
Use, hereinafter referred to as “the Committee”, for the
application of the procedure laid down in Articles 36,
37 and 38.

the Commission, or

authorised

2. With a view to promoting the harmonisation of
veterinary medicinal
the
products
Community, and to strengthening the efficiency of the
provisions of Articles 10 and 11, Member States shall
send to the coordination group, no later than 30 April
2005, a list of veterinary medicinal products for which a
harmonised summary of product characteristics should be
prepared.

in

The coordination group shall agree on a list of medicinal
products, on the basis of proposals sent by Member States,
and shall forward the list to the Commission.

The medicinal products on the list shall be subject to the
provisions in paragraph 1 in accordance with a timetable
established in cooperation with the Agency.

The Commission, acting in collaboration with the Agency,
and taking into consideration the views of the interested
parties, shall agree the final list and timetable.

Article 35

1. Member States or the Commission or the applicant
or marketing authorisation holder shall, in specific cases
where the interests of the Community are involved, refer
the matter to the Committee for the application of the
procedure laid down in Articles 36, 37 and 38 before a
decision is reached on a request for a marketing author-
isation or on the suspension or withdrawal of an author-
isation, or on any other variations to the terms of a
marketing authorisation which appear necessary, so as to
take account in particular of the information collected in
accordance with Title VII.

The Member State concerned or the Commission shall
clearly identify the question which is referred to the
inform the
Committee
applicant or the marketing authorisation holder.

consideration and shall

for

The Member State and the applicant or the marketing
authorisation holder shall forward to the Committee all
available information relating to the matter in question.

to the Committee concerns a
2. Where the referral
range of medicinal products or a therapeutic class, the
Agency may limit the procedure to specific parts of the
authorisation.

In that case, Article 39 shall apply to those medicinal
products only if they are covered by the marketing auth-
orisation procedure referred to in this Chapter.

Article 36

1. When reference is made to the procedure laid down
in this Article, the Committee shall consider the matter
concerned and shall issue a reasoned opinion within 60
days of the date on which the matter was referred to it.

in cases

submitted to the Committee

However,
in
accordance with Articles 34 and 35, this period may be
extended by the Committee for a further period of up to
90 days, taking into account the views of the marketing
authorisation holders concerned.

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In an emergency, and on a proposal from its Chairman,
the Committee may agree to a shorter deadline.

In order to consider the matter, the Committee shall
2.
appoint one of its members to act as rapporteur. The
Committee may also appoint
to
advise it on specific questions. When appointing such
experts,
tasks and
specify the time limit for the completion of these tasks.

the Committee shall define their

independent experts

Before issuing its opinion,

the Committee shall
3.
the marketing authorisation
provide the applicant or
holder with an opportunity to present written or oral
explanations within a time limit that it will specify.

include the draft
the Committee shall
The opinion of
summary of product characteristics and the drafts of the
labelling and package leaflet.

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

The Committee may suspend the time limit referred to in
paragraph 1 to allow the applicant or the marketing auth-
orisation holder to prepare the explanations.

4.
The Agency shall forthwith inform the applicant or
the marketing authorisation holder when the opinion of
the Committee is that:

— the application does not satisfy the criteria for author-

isation, or

— the summary of product characteristics proposed by
the applicant or the marketing authorisation holder
in accordance with Article 14 should be amended, or

— the

authorisation should be

to
considered
conditions, with regard to conditions
essential for the safe and effective use of the veterinary
medicinal product including pharmacovigilance, or

granted subject

— a marketing authorisation should be suspended, varied

or revoked.

Within 15 days after receipt of the opinion, the applicant
or the marketing authorisation holder may notify the
Agency in writing of his intention to request a re-exam-
ination of the opinion. In that case, he shall forward to the
Agency the detailed grounds for the request within 60
days after receipt of the opinion.

Within 60 days following receipt of the grounds for the
request, the Committee shall re-examine its opinion in
accordance with the fourth subparagraph of Article
62(1) of Regulation (EC) No 726/2004. The reasons for
the conclusion reached shall be annexed to the assessment
report referred to in paragraph 5 of this Article.

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

In the event of an opinion in favour of granting or main-
taining
following
documents shall be annexed to the opinion:

a marketing

authorisation,

the

(a) a draft summary of

the product characteristics, as
referred to in Article 14; where necessary this will
reflect the differences in the veterinary conditions in
Member States;

(b) any conditions affecting the authorisation within the

meaning of paragraph 4;

(c) details of any recommended conditions or restrictions
with regard to the safe and effective use of
the
veterinary medicinal product; and

(d) drafts of the labelling and package leaflet.

Article 37

after

Within 15 days
the
Commission shall prepare a draft of the decision to be
taken in respect of the application, taking into account
Community law.

the opinion,

receipt of

In the event of a draft decision that envisages the granting
of a marketing authorisation, the documents referred to in
the second subparagraph of Article 36(5) shall be annexed.

If, exceptionally, the draft decision is not in accordance
with the opinion of the Agency, the Commission shall also
annex a detailed explanation of
the
differences.

the reasons

for

The draft decision shall be forwarded to Member States
and the applicant or marketing authorisation holder.’;

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21) Article 38 shall be amended as follows:

25) in Article 44, the following paragraph shall be added:

(a) paragraph 1 shall be replaced by the following:

The Commission shall take a final decision in
‘1.
accordance with, and within 15 days after the end
of, the procedure referred to in Article 89(3).’;

(b) In paragraph 2, the second and third indents shall be

replaced by the following:

‘— Member States shall have 22 days to forward their
written observations on the draft decision to the
Commission. However,
if a decision has to be
taken urgently, a shorter time-limit may be set
by the Chairman according to the degree of
urgency
shall not,
otherwise than in exceptional circumstances, be
shorter than 5 days,

involved. This

time-limit

— Member States shall have the option of submitting
the draft decision be
that
a written request
discussed in a plenary meeting of the Standing
Committee.’;

(c) paragraph 3 shall be replaced by the following:

‘3.
A decision as referred to in paragraph 1 shall be
addressed to all Member States and communicated to
the marketing authorisation holder or the applicant for
information. The concerned Member States and the
reference Member
or
withdraw marketing authorisation, or vary the terms
of a marketing authorisation as necessary to comply
with the decision within 30 days of its notification and
shall refer to it. They shall inform the Commission and
the Agency accordingly.’;

either

grant

State

shall

22) in Article 39, the third subparagraph of paragraph 1 shall

be deleted;

23) in Article 42, paragraph 2 shall be replaced by the

following:

At

least every ten years

‘2.
the Commission shall
publish a report on experience gained on the basis of
the procedures provided for in this chapter and shall
propose any amendments necessary to improve the
procedures. The Commission shall submit this report to
the European Parliament and the Council.’;

24) Article 43 shall be replaced by the following:

‘Article 43

Articles 33(4), (5) and (6) and 34 to 38 shall not apply to
the homeopathic veterinary medicinal products referred to
in Article 17.

Articles 32 to 38 shall not apply to the homeopathic
veterinary medicinal products referred to in Article 19(2).’;

‘4.
The Member State shall forward to the Agency a
copy of the manufacturing authorisations referred to in
paragraph 1. The Agency shall enter that information in
the Community database referred to in Article 80(6).’;

26) in Article 50, point (f) shall be replaced by the following:

‘(f) comply with the principles and the guidelines on good
manufacturing practice for medicinal products and use
as starting materials only active substances which have
been manufactured in accordance with the detailed
for
guidelines on good manufacturing practice
starting materials.’;

27) the following Article shall be inserted:

‘Article 50a

starting materials

For the purposes of this Directive, manufacturing
1.
shall
active substances
for use as
the
include the complete or partial manufacture or
import of an active substance used as a starting material,
as defined in Part 2, Section C of Annex I, and the various
processes of dividing up, packaging or presentation prior
to its incorporation in a veterinary medicinal product,
including repackaging or re-labelling, such as carried out
by a starting material distributor.

2.
Any amendments which may be necessary to adapt
the provisions of this Article to scientific and technical
adopted in accordance with the
progress
procedure referred to in Article 89(2).’;

shall be

28) in Article 51, the following paragraphs shall be added:

‘The principles of good manufacturing practice as regards
the manufacturing of active substances for use as starting
materials as referred to in Article 50(f) shall be adopted in
the form of detailed guidelines.

The Commission shall also publish guidelines on the form
and content of the authorisation referred to in Article
44(1), the reports referred to in Article 80(3) and the
form and content of the certificate of good manufacturing
practice referred to in Article 80(5).’;

29) in Article 53, paragraph 1 shall be replaced by the

following:

‘1. Member States shall ensure that the qualified person
referred to in Article 52(1) fulfils the conditions of qualifi-
cation referred to in paragraphs 2 and 3.’;

30) in Article 54, paragraph 1 shall be replaced by the

following:

A person engaging,

in a Member State,

in the
‘1.
activities of the person referred to in Article 52(1) on
the
date on which Directive 81/851/EEC became
applicable, without complying with the provisions of
Article 53, shall be eligible to continue to engage in
those activities within the Community.’;

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31) in Article 55, paragraph 1(b) shall be replaced by the

(v) Point (g) shall be replaced by the following:

following:

‘(b)

in the case of veterinary medicinal products coming
from third countries, even if manufactured in the
Community, each production batch imported has
undergone in a Member State a full qualitative
analysis, a quantitative analysis of at
the
active substances, and all the other tests or controls
necessary to ensure the quality of veterinary medicinal
products in accordance with the requirements of the
marketing authorisation.’;

least all

32) Article 58 shall be amended as follows:

(a) paragraph 1 shall be amended as follows:

(i) The introductory wording shall be replaced by the

following:

the

the medicinal products
‘Except
in the case of
competent
referred to in Article 17(1),
authority shall approve the immediate packaging
and outer packaging of veterinary medicinal
the following
products. Packaging shall bear
information, which shall
conform with the
particulars and documents provided pursuant to
Articles 12 to 13d and the summary of product
characteristics,
in legible
shall
characters:’;

appear

and

(ii) Points

(a) and (b)

shall be replaced by the

following:

‘(a)

the name of the medicinal product, followed
by its strength and pharmaceutical form. The
common name shall appear if the medicinal
product contains only one active substance
and its name is an invented name;

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

(iii) Point (e) shall be replaced by the following:

‘(e) name or corporate name and permanent
address or registered place of business of
the marketing authorisation holder
and,
where
representative
designated by the marketing authorisation
holder;’;

appropriate, of

the

(iv) Point (f) shall be replaced by the following:

‘(g)

for

the withdrawal
veterinary
period
medicinal products to be administered to
the species
food-producing species,
foodstuffs
concerned and for
concerned (meat
eggs, milk,
honey), including those for which the with-
drawal period is zero;’;

for all
the various

and offal,

(vi) Point (j) shall be replaced by the following:

‘(j) specific precautions relating to the disposal of
unused medicinal products or waste derived
from veterinary medicinal products, where
appropriate, as well as a reference to any
appropriate collection system in place;’;

(vii) Point (l) shall be replaced by the following:

‘(l)

the words “For animal treatment only” or, in
the case of the medicinal products referred to
in Article 67,
animal
treatment only — to be supplied only on
veterinary prescription”.’;

the words

“For

(b) the following paragraph shall be added:

that

In the case of medicinal products that have been
‘5.
granted a marketing authorisation under Regulation
(EC) No 726/2004, Member States may permit or
require
the outer packaging bear additional
information concerning distribution, possession, sale
or any necessary precautions, provided that
such
information is not
in infringement of Community
law or the terms of the marketing authorisation, and
is not promotional.

This additional information shall appear in a box with
a blue border
clearly from the
information referred to in paragraph 1.’;

to separate

it

33) Article 59 shall be amended as follows:

(a) the introductory wording of paragraph 1 shall be

replaced by the following:

‘1.
As regards ampoules, the particulars listed in the
first paragraph of Article 58(1) shall be given on the
outer package. On the immediate packaging, however,
only the following particulars shall be necessary:’;

(b) paragraphs 2 and 3 shall be replaced by the following:

As

small

regards

immediate

‘2.
packaging
containing a single dose, other than ampoules, on
the particulars
which it
to give
mentioned in paragraph 1,
requirements of
the
Article 58(1),
(2) and (3) shall apply only to the
outer package.

impossible

is

‘(f)

the species of animal for which the veterinary
medicinal product
the method
and, if necessary, the route of administration.
Space shall be provided for the prescribed
dose to be indicated;’;

is intended;

3.
The particulars mentioned in the third and sixth
indents of paragraph 1 shall appear on the outer
package and on the immediate packaging of
the
medicinal products in the language or languages of
the country in which they are placed on the market.’;

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34) Article 60 shall be replaced by the following:

‘Article 60

Where there is no outer package, all the particulars which
should feature on such a package pursuant to Articles 58
and 59 shall be shown on the immediate packaging.’;

35) Article 61 shall be amended as follows:

(a) paragraph 1 shall be replaced by the following:

The

leaflet

inclusion of a package

‘1.
in the
packaging of veterinary medicinal products shall be
obligatory unless all the information required by this
Article can be conveyed on the immediate packaging
and the outer packaging. Member States shall take all
appropriate measures to ensure that the package leaflet
relates solely to the veterinary medicinal product with
is included. The package leaflet shall be
which it
that are comprehensible to the
written in terms
language or
general public
in which the
languages of
medicinal product is marketed.

and in the official

the Member

State

from being written in several

The first subparagraph shall not prevent the package
languages,
leaflet
provided that the information given is identical in all
the languages.

Competent authorities may exempt labels and package
leaflets for specific veterinary medicinal products from
the obligation for certain particulars to appear and for
the leaflet to be in the official language or languages of
the Member State in which the product is placed on
the market, when the product is intended to be admin-
istered only by a veterinarian.’;

(b) paragraph 2 shall be amended as follows:

(i) The introductory wording shall be replaced by the

following:

The competent authorities

‘2.
shall approve
package leaflets. Leaflets shall contain at least the
indicated,
following information,
which shall
and
documents provided pursuant
to Articles 12 to
13d and the approved summary of product charac-
teristics:’;

conform to the particulars

in the order

form. The common name shall appear if the
product contains only one active substance and
its name is an invented name. Where the
medicinal product is authorised according to
the procedure provided for in Articles 31 to
43 under different names in the Member States
concerned, a list of the names authorised in
each Member State;’;

(c) paragraph 3 shall be deleted;

36) Article 62 shall be replaced by the following:

‘Article 62

Where the provisions of this Title are not observed and a
formal notice addressed to the person concerned has been
ineffectual, Member States' competent authorities may
suspend or revoke the marketing authorisation.’;

37) Article 64(2) shall be amended as follows:

(a) the introductory wording shall be replaced by the

following:

‘2.
In addition to the clear mention of the words
“homeopathic veterinary medicinal product without
approved therapeutic indications”, the labelling and,
where appropriate, package leaflet
for the homeo-
pathic veterinary medicinal products referred to in
Article 17(1) shall bear
the following information
and no other information:’;

(b) the first indent shall be replaced by the following:

‘— the scientific name of the stock or stocks followed
by the degree of dilution, using the symbols of the
pharmacopoeia used in accordance with point (8)
the homeopathic veterinary
of Article 1.
If
is composed of more than
medicinal product
labelling may mention an
one
stock,
invented name
scientific
names of the stocks,’;

in addition to the

the

38) the title of Title VI shall be replaced by the following:

‘TITLE VI

POSSESSION, DISTRIBUTION AND DISPENSING OF
VETERINARY MEDICINAL PRODUCTS’;

(ii) Points

(a) and (b)

shall be replaced by the

following:

39) Article 65 shall be amended as follows:

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

(b) name of

the veterinary medicinal product
followed by its strength and pharmaceutical

(a) the following paragraph shall be inserted:

‘3a.
The holder of a distribution authorisation shall
have an emergency plan guaranteeing the effective
implementation of any recall operation ordered by
the competent authorities or undertaken in coop-
eration with the manufacturer of
the medicinal
product in question or the holder of the marketing
authorisation.’;

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(b) the following paragraph shall be inserted:

‘5.
Any distributor, not being the marketing auth-
orisation holder, who imports a product from another
Member State shall notify the marketing authorisation
holder and the competent authority in the Member
State to which the product will be imported of his
intention to import it. In the case of products which
have not been granted an authorisation pursuant to
Regulation (EC) No 726/2004, the notification to the
competent authority shall be without prejudice to
additional procedures provided for in the legislation
of that Member State.’;

40) Article 66 shall be amended as follows:

(a) paragraph 2 shall be amended as follows:

to stricter Community or
‘Without prejudice
national rules relating to dispensing veterinary
medicinal products and serving to protect human
and animal health, a veterinary prescription shall
be required for dispensing to the public the
following veterinary medicinal products:’;

(ii) The following point shall be inserted:

‘(aa) veterinary medicinal products

for

food-

producing animals.

States may

grant
However, Member
requirement
exemptions
from
according
in
criteria
accordance with the procedure referred to
in Article 89(2).

established

this

to

(i) The introductory wording shall be replaced by the

following:

Member States may continue
national provisions until either:

to apply

‘Any person permitted under paragraph 1 to
supply veterinary medicinal products
shall be
required to keep detailed records for veterinary
medicinal products that may be supplied only on
following information being
prescription,
recorded in respect of each incoming or outgoing
transaction:’;

the

(ii) The third subparagraph shall be replaced by the

following:

‘These records shall be available for inspection by
five
the competent authorities for a period of
years.’;

(i) the date of application of the decision
adopted in accordance with the first
subparagraph; or

(ii) 1 January 2007, if no such decision has
been adopted by 31 December 2006;’;

(iii) The third indent of point (b) shall be deleted;

(iv) Point (d) shall be replaced by the following:

‘(d) official formula, within the meaning of Article
3(2)(b), intended for food-producing animals.’;

(b) paragraph 3 shall be replaced by the following:

(b) the

second paragraph shall be

replaced by the

following:

‘3. Member States may permit the supply on their
territory of veterinary medicinal products for food-
producing animals for which a veterinary prescription
is required by or under the supervision of a person
registered for this purpose who provides guarantees
record-keeping and
with respect
law. Member
reporting in accordance with national
States
relevant
law. This provision shall not
provisions of national
apply to the supply of veterinary medicinal products
for
treatment of bacterial
infections.’;

the oral or parenteral

the Commission of

to qualifications,

shall notify

that,

in the

‘Member States shall take all necessary measures to
ensure
case of medicinal products
supplied only on prescription, the quantity prescribed
and supplied shall be restricted to the minimum
amount
therapy
the
concerned.

treatment or

required for

In addition, a prescription shall be required for new
veterinary medicinal products containing an active
substance that has been authorised for use in a
veterinary medicinal product for fewer than five years.’;

(c) paragraph 4 shall be deleted;

42) the first paragraph of Article 69 shall be replaced by the

following:

41) Article 67 shall be amended as follows:

(a) the first paragraph shall be amended as follows:

(i) The introductory wording shall be replaced by the

following:

‘Member States shall ensure that the owners or keepers of
food-producing animals can provide proof of purchase,
possession and administration of veterinary medicinal
products to such animals for five years after their adminis-
tration, including when the animal is slaughtered during
the five-year period.’;

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43) the introductory wording of Article 70 shall be replaced

47) The following article shall be inserted:

by the following:

‘Article 73a

‘By way of derogation from Article 9 and without
prejudice to Article 67, Member States shall ensure that
veterinarians providing services in another Member State
can take with them and administer to animals small
quantities of veterinary medicinal products not exceeding
daily requirements other than immunological veterinary
medicinal products which are not authorised for use in
the Member State in which the services are provided (here-
inafter: “host Member State”), provided that the following
conditions are satisfied:’;

44) the following subparagraph shall be added to Article 71(1):

‘The Member State may also invoke the provisions of the
first subparagraph in order to withhold marketing author-
isation in accordance with a decentralised procedure as
provided for in Articles 31 to 43.’;

45) in Article 72, paragraph 2 shall be replaced by the

following:

‘2. Member States may impose specific requirements on
veterinary practitioners and other health-care professionals
in respect of the reporting of suspected serious or unex-
pected adverse reactions and human adverse reactions.’;

46) Article 73 shall be amended as follows:

(a) the first paragraph shall be replaced by the following:

reactions

decisions

regulatory

concerning

suspected adverse

‘In order to ensure the adoption of appropriate and
harmonised
the
veterinary medicinal products authorised within the
Community, having regard to information obtained
about
to veterinary
medicinal products under normal conditions of use,
Member States shall administer a veterinary phar-
macovigilance system. This system shall be used to
surveillance of
collect
particular
veterinary medicinal
reference to adverse reactions
in animals and in
human beings
relating to the use of veterinary
medicinal products, and to evaluate such information
scientifically.’;

in the
products, with

information useful

(b) after the second paragraph, the following paragraph

shall be inserted:

‘Member States shall ensure that suitable information
collected within this system is communicated to other
Member States and the Agency. This information shall
be recorded in the database referred to in point (k) of
the second subparagraph of Article 57(1) of Regulation
(EC) No 726/2004 and shall be permanently accessible
to all Member States and without delay to the public.’;

funds

activities
The management of
connected with pharmacovigilance,
the operation of
communication networks and market surveillance shall
be under the permanent control of the competent auth-
orities in order to guarantee their independence.’

intended

for

48) The introductory wording of

the second paragraph of

Article 74 shall be replaced by the following:

‘That qualified person shall reside in the Community and
shall be responsible for the following:’;

49) Article 75 shall be replaced by the following:

‘Article 75

The marketing authorisation holder shall maintain
1.
detailed records of
reactions
occurring within the Community or in a third country.

suspected adverse

all

Save in exceptional circumstances, these reactions shall be
communicated electronically in the form of a report in
accordance with the guidelines referred to in Article 77(1).

2.
The marketing authorisation holder shall record all
suspected serious adverse reactions and human adverse
relating to the use of veterinary medicinal
reactions
to his attention, and report
products that are brought
them promptly to the
the
competent
Member State on whose territory the incident occurred,
the
and no later
information.

than 15 days following receipt of

authority of

The marketing authorisation holder shall also record all
suspected serious adverse reactions and human adverse
reactions
related to the use of veterinary medicinal
products of which he can reasonably be expected to
have knowledge, and report
them promptly to the
competent authority of Member State on whose territory
the incident occurred, and no later than 15 days following
receipt of the information.

3.
The marketing authorisation holder shall ensure that
all suspected serious unexpected adverse reactions, human
adverse reactions and any suspected transmission via a
veterinary medicinal product of any infectious agent
occurring on the
third country are
territory of a
reported promptly in accordance with the guidelines
referred to in Article 77(1), so that they are available to
the Agency and the competent authorities of the Member
States in which the veterinary medicinal product is auth-
orised, and no later than 15 days following the receipt of
the information.

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By way of derogation from paragraphs 2 and 3, in
4.
the case of veterinary medicinal products which are
covered by Directive 87/22/EEC, have benefited from the
authorisation procedures under Articles 31 and 32 of this
the procedures
Directive or have been the subject of
provided for in Articles 36, 37 and 38 of this Directive,
the marketing authorisation holder
shall additionally
ensure that all suspected serious adverse reactions and
human adverse reactions occurring in the Community
are reported in such a way so as to be accessible to the
reference Member
authority
designated as
reference Member State. The reference
Member State shall assume responsibility for the analysis
and follow-up of any such adverse reactions.

competent

State or

a

5.
Unless other requirements have been laid down as a
condition for the granting of the marketing authorisation
or subsequently as indicated in the guidelines referred to in
Article 77(1), reports of all adverse reactions shall be
submitted to the competent authorities in the form of a
periodic safety update report, immediately upon request or
the
least every six months after authorisation until
at
placing on the market. Periodic safety update reports
shall also be submitted immediately upon request or at
least
two years
following the initial placing on the market and once a
year for the following two years. Thereafter, the reports
shall be submitted at three-yearly intervals, or immediately
upon request.

every six months during the

first

Member States shall take the necessary measures to ensure
to
that a marketing authorisation holder who fails
discharge
to effective,
proportionate and dissuasive penalties.

these obligations

subject

is

___________
(*) OJ L 159, 27.6.2003, p. 1.’;

50) Article 76(1) shall be replaced by the following:

shall

in collaboration with Member States
‘1.
The Agency,
and the Commission,
set up a data-processing
network to facilitate the exchange of pharmacovigilance
veterinary medicinal products
information regarding
to allow the
marketed in the Community in order
competent authorities to share the information at
the
same time.’;

51) in Article 77(1), the second subparagraph shall be replaced

by the following:

‘In accordance with those guidelines, the marketing auth-
orisation holder shall use internationally agreed veterinary
medical terminology for the transmission of reports on
adverse reactions.

The Commission shall publish the guidelines, which shall
take account of international harmonisation work achieved
in the field of pharmacovigilance.’;

The periodic safety update reports shall include a scientific
evaluation of the risk-benefit balance of the veterinary
medicinal product.

52) Article 78 shall be amended as follows:

(a) paragraph 2 shall be replaced by the following:

6.
Amendments to paragraph 5 may be adopted in
accordance with the procedure referred to in Article
the experience gained from its
89(2)
operation.

in the light of

Following the granting of a marketing authorisation,
7.
the holder of
the
amendment of the periods referred to in paragraph 5 of
this Article in accordance with the procedure laid down by
Commission Regulation (EC) No 1084/2003 (*).

such authorisation may request

8.
The holder of a marketing authorisation may not
communicate information relating to pharmacovigilance
concerns to the general public in relation to its authorised
veterinary medicinal product without giving prior or
simultaneous notification to the competent authority.

or

animal

If urgent action is necessary for protecting
‘2.
State
health,
human
concerned may suspend the marketing authorisation
of a veterinary medicinal product, provided that the
Agency, the Commission and the other Member States
are informed on the following working day at the
latest.’;

the Member

(b) the following paragraph shall be added:

‘3. When the Agency is informed in accordance
it shall give its opinion as
with paragraphs 1 or 2,
soon as possible, according to the urgency of
the
matter.

On the basis of this opinion, the Commission may
request all Member States in which the veterinary
is marketed to take temporary measures
medicinal
immediately.

In any case,
the marketing authorisation holder shall
ensure that such information is presented objectively and
is not misleading.

Final measures shall be adopted in accordance with the
procedure referred to in Article 89(3).’;

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Official Journal of the European Union

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53) Article 80 shall be amended as follows:

(a) paragraph 1 shall be replaced by the following:

if

and,

ensure, by means of
necessary,

The competent authority of the Member State
‘1.
repeated
concerned shall
inspections
unannounced
inspections, and where appropriate, by asking an
Official Medicines Control Laboratory or a laboratory
tests on
designated for
samples,
relating to
legal
that
veterinary medicinal products are complied with.

that purpose to conduct
the

requirements

The competent authority may also carry out unan-
nounced inspections at the premises of manufacturers
of active substances used as starting materials for
veterinary medicinal products, and of the premises of
it
the marketing
considers
suspecting
that
non-compliance with the provisions of Article 51.
Such inspections may also be carried out at
the
request of another Member State, the Commission or
the Agency.

authorisation holder whenever
there

are grounds

for

In order to verify whether the data submitted in order
to obtain a conformity certificate comply with the
monographs of the European Pharmacopoeia, the stan-
dardisation body for nomenclatures and quality norms
within the meaning of the Convention relating to the
elaboration
Pharmacopoeia (*)
(European Directorate for the Quality of Medicines)
may ask the Commission or the Agency to request
such an inspection when the
starting material
concerned is the subject of a European Pharmacopoeia
monograph.

European

of

a

authority of

competent

The
concerned may carry out
material manufacturers at
request.

the Member State
inspections of
starting
the manufacturer's own

Such inspections shall be carried out by authorised
representatives of the competent authority who shall
be empowered to:

(a)

inspect manufacturing or trading establishments
and any laboratories entrusted by the holder of
the manufacturing authorisation with the task of
carrying out control tests pursuant to Article 24;

(b) take samples including with a view to an inde-
pendent 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, subject to the provisions in force in
the Member States on 9 October 1981 placing
restrictions on these powers with regard to the
description of the manufacturing method;

(d) inspect the premises, records and documents of
marketing authorisation holders or any firms

performing the activities described in Title VII,
and in particular Articles 74 and 75 thereof, on
behalf of a marketing authorisation holder.

___________
(*) OJ L 158, 25.6.1994, p. 19.’;

(b) paragraph 3 shall be replaced by the following:

The authorised representatives of the competent
‘3.
authority shall report after each of
the inspections
mentioned in paragraph 1 on whether the principles
and guidelines on good manufacturing practice
referred to in Article 51 or, where appropriate, the
requirements set out in Title VII, are being complied
with. The inspected manufacturer or market author-
isation holder shall be informed of
the content of
such reports.’;

(c) the following paragraphs shall be added:

‘4. Without prejudice to any arrangements which
may have been concluded between the Community
and a third country, a Member State, the Commission
or the Agency may require a manufacturer established
in a third country to undergo an inspection as referred
to in paragraph 1.

5. Within 90 days after an inspection as referred to
in paragraph 1, a certificate of good manufacturing
the
practice shall be issued to the manufacturer if
in
inspection established that
the manufacturer
and
question is
guidelines
as
provided for by Community law.

complying with the principles
practice

good manufacturing

on

In the event of an inspection carried out at the request
the European Pharmacopoeia, a certificate of
of
compliance with the monograph shall be issued,
if
appropriate.

6. Member States shall enter the certificates of good
manufacturing practice which they
in a
Community database managed by the Agency on
behalf of the Community.

issue

7.
If the outcome of the inspection as referred to in
paragraph 1 is that the manufacturer does not comply
with the principles and guidelines of good manufac-
turing practice as provided for by Community legis-
lation,
entered in the
Community database as referred to in paragraph 6.’;

information shall be

the

54) Article 82 shall be replaced by the following:

‘Article 82

1. Where it considers it necessary for reasons of human
or animal health, a Member State may require the
for an immunological
marketing authorisation holder
veterinary medicinal product
samples of
batches of the bulk product and/or veterinary medicinal
product
for control by an Official Medicines Control
Laboratory before the product is put into circulation.

to submit

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Official Journal of the European Union

30.4.2004

On request by the

the
2.
marketing authorisation holder shall promptly supply the
samples referred to in paragraph 1,
together with the
reports of the control referred to in Article 81(2).

authorities,

competent

States

the other
The competent authority shall
Member
veterinary medicinal
in which the
product is authorised as well as the European Directorate
for the Quality of Medicines of its intention to control
batches or the batch in question.

inform all

In such cases,
Member
State
paragraph 1.

the competent authorities of another
the provisions of
shall not

apply

repeat, on the samples provided, all

After studying the control reports referred to in
3.
Article 81(2), the laboratory responsible for the control
shall
the tests
carried out by the manufacturer on the finished product,
in accordance with the relevant provisions shown in the
dossier for marketing authorisation.

tests

The list of
to be repeated by the laboratory
responsible for the control shall be restricted to justified
tests, provided that all Member States concerned, and if
appropriate the European Directorate for the Quality of
Medicines, agree to this.

For immunological veterinary medicinal products auth-
orised under Regulation (EC) No 726/2004, the list of
tests to be repeated by the control
laboratory may be
reduced only after agreement by the Agency.

All Member States concerned shall recognise the

4.
results of the tests.

5.
Unless the Commission is informed that a longer
period is necessary to conduct the tests, Member States
is completed within 60
this control
shall ensure that
days of receipt of the samples.

concerned,

The competent authority shall notify the other Member
the
States
Quality of Medicines, the marketing authorisation holder
and, if appropriate, the manufacturer, of the results of the
tests within the same period of time.

the European Directorate

for

If a competent authority concludes that a batch of a
veterinary medicinal product is not in conformity with
the manufacturer or the specifi-
the control report of
it
cations provided for in the marketing authorisation,
shall
the
marketing authorisation holder and the manufacturer,
where appropriate, and shall
inform accordingly the
other Member States in which the veterinary medicinal
product is authorised.’;

the necessary measures vis-a-vis

take

all

55) Article 83 shall be amended as follows:

(a) paragraph 1 shall be amended as follows:

(i) The introductory words shall be replaced by the

following:

‘Member
suspend,
authorisations when it is clear that:’;

shall
States'
revoke, withdraw or vary marketing

competent

authorities

(ii) Point (a) shall be replaced by the following:

‘(a)

the risk-benefit assessment of the veterinary
medicinal product
is, under the authorised
conditions of use, unfavourable, particular
regard being had to the benefits for animal
health and welfare and to consumer safety,
when the authorisation concerns a veterinary
medicinal product for zootechnical use;’;

(iii) The second subparagraph of point

(e) shall be

deleted;

(iv) Point (f) shall be replaced by the following:

‘(f)

information
given
documents pursuant
and 27 is incorrect;’;

(v) Point (h) shall be deleted;

in

the

application
to Articles 12 to 13d

(vi) The

following second subparagraph shall be

added:

a

Community

legislative
‘However, when
framework is in the course of being adopted, the
competent authority may refuse authorisation for
a veterinary medicinal product where such action
is necessary for the protection of public health,
consumer and animal health.’;

(b) paragraph 2 shall be amended as follows:

(i) The introductory words shall be replaced by the

following:

‘Marketing
suspended,
authorisations may be
revoked, withdrawn or varied when it is estab-
lished that:’;

(ii) Point (a) shall be replaced by the following:

‘(a)

the particulars supporting the application, as
provided for in Articles 12 to 13d, have not
been amended in accordance with Article
27(1) and (5);’;

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Official Journal of the European Union

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56) in Article 84, point (a) of paragraph 1 shall be replaced by

the following:

the Member State concerned shall be valid for the

of
Community.

‘(a)

is clear that

the risk-benefit assessment of

it
the
veterinary medicinal product is, under the authorised
conditions of use, unfavourable, particular
regard
being had to the benefits for animal health and
welfare and to the safety and health benefits for the
consumer, when the
a
veterinary medicinal product for zootechnical use.’;

authorisation concerns

57) in Article 85, the following paragraph shall be added:

‘3. Member States shall prohibit the advertising to the
general public of veterinary medicinal products that:

(a)

in accordance with Article 67, are available on
veterinary prescription only; or

(b) contain psychotropic drugs or narcotics, such as those
covered by the United Nations Conventions of 1961
and 1971.’;

However, by way of exception, if a Member State has not
been able, for serious reasons of human or animal health,
to accept the conclusions of an inspection as referred to in
Article 80(1), that Member State shall forthwith inform the
Commission and the Agency. The Agency shall inform the
Member States concerned.

informed of

such serious
When the Commission is
reasons,
it may, after consulting the Member States
concerned, ask the inspector of the competent supervisory
authority to carry out a new inspection; the inspector may
be accompanied by two other inspectors from Member
States that are not parties to the disagreement.’;

60) in Article 94, the third subparagraph shall be replaced by

the following:

‘Decisions to grant or revoke a marketing authorisation
shall be made publicly available.’;

58) in Article 89, paragraphs 2 and 3 shall be replaced by the

61) Article 95 shall be replaced by the following:

following:

‘2. Where reference is made to this paragraph, Articles
5 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision
1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Articles
4 and 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision
1999/468/EC shall be set at one month.

‘Article 95

Member States shall not permit
foodstuffs for human
consumption to be taken from test animals unless the
competent authorities have established an appropriate
withdrawal period. The withdrawal period shall either:

(a) be at least as laid down in Article 11(2),

appropriate,

where
nature of the substance being tested; or

a safety factor

including,
reflecting the

(b) if maximum residue limits have been established by
the Community in accordance with Regulation (EEC)
No 2377/90, ensure that this maximum limit will not
be exceeded in foodstuffs.’;

The Standing Committee shall adopt

4.
its rules of
procedure. These rules of procedure shall be made public.’;

62) the following articles shall be inserted:

59) Article 90 shall be replaced by the following:

‘Article 95a

‘Article 90

Member States shall take all necessary measures to ensure
that
the competent authorities concerned communicate
the appropriate information to each other, particularly
regarding compliance with the requirements adopted for
the
the authorisations
certificates referred to in Article 80(5) or for authorisation
to place products on the market.

referred to in Article 44,

for

Upon reasoned request, Member States shall
forthwith
communicate the reports referred to in Article 80(3) to
the competent authorities of another Member State.

The conclusions
reached following an inspection as
referred to in Article 80(1) carried out by the inspectors

Member States shall ensure that appropriate collection
systems are in place for veterinary medicinal products
that are unused or expired.

Article 95b

When a veterinary medicinal product is to be authorised
in accordance with Regulation (EC) No 726/2004 and the
Scientific Committee in its opinion refers to recommended
conditions or restrictions with regard to the safe and
the veterinary medicinal product as
effective use of
provided for in Article 34(4)(d) of
that Regulation, a
decision addressed to Member States shall be adopted in
accordance with the procedure laid down in Articles 37
and 38 of this Directive, for the implementation of those
conditions or restrictions.’

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Article 2

Article 4

The periods of protection provided for in Article 1, point 6,
which amends Article 13 of Directive 2001/82/EC, shall not
apply to reference medicinal products for which an application
for authorisation has been submitted before the date of trans-
position referred to in Article 3 first paragraph.

This Directive shall enter into force on the day of its publi-
cation in the Official Journal of the European Union.

Article 3

This Directive is addressed to the Member States.

Article 5

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive by 30 October 2005 at
the latest. They shall
immediately inform the Commission thereof.

Done at Strasbourg, 31 March 2004.

When Member States adopt these measures, they shall contain
a reference to this Directive or shall be accompanied by such
reference on the occasion of their official publication. The
methods of making such reference shall be laid down by the
Member States.

For the European Parliament

The President

P. COX

For the Council

The President

D. ROCHE