Common Position (EC) No 62/2003 of 29 September 2003 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a directive of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (Text with EEA relevance)
Date: 2003-09-29
Institutions: Council of the European Union
Subjects: approximation of laws, legal code, pharmaceutical legislation, public health, single market, veterinary drug

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COMMON POSITION (EC) No 62/2003

adopted by the Council on 29 September 2003

with a view to the adoption of a Directive 2003/. . ./EC of the European Parliament and of the
Council of . . . amending Directive 2001/82/EC on the Community code relating to veterinary
medicinal products

(2003/C 297 E/03)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

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

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

(2) 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
in the light of the experience
such products. However,
gained,
that new measures are
necessary to eliminate the remaining obstacles to free
movement.

it has become clear

(3)

It is therefore necessary to align national laws, regulations
and administrative provisions that contain differences with
regard to the basic principles in order to promote the
operation of
adversely
affecting public health.

internal market without

the

(4) 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 authorisations for
veterinary medicinal products, 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

(1) OJ C 75 E, 26.3.2002, p. 189.
(2) OJ C 61, 14.3.2003, p. 1.
(3) Opinion of the European Parliament of 23 October 2002 (not yet
published in the Official Journal), Council Common Position of 29
September 2003 and Decision of the European Parliament of . . .
(not yet published in the Official Journal).

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

the pharmaceutical

of
medicinal products within the Community.

industry or trade in veterinary

(5) 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
the Evaluation of Medicinal Products (5)
Agency for
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.

(6)

In the light of the Commission's report on the experience
acquired, it has proved necessary to improve the operation
of the marketing authorisation procedures for veterinary
medicinal products in the Community.

of

the emergence of new therapies and of
number

(7) 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 for the quality, safety and efficacy
of veterinary medicinal products. In order to take account
both of
the
‘borderline’ products
so-called
growing
between the medicinal product sector and other sectors,
the definition of ‘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 charac-
teristics of pharmaceutical
legislation, provision should
be made for such legislation to apply. With the same
objective of clarifying situations, where a given product
comes under
the definition of a veterinary medicinal
product, but could also fall within the definition of
in cases of
other
it
doubt and in order to ensure legal certainty,
to state
explicitly which provisions have to be complied with.
Where a product comes clearly under the definition of
other product categories,
feed
additives or biocides, this Directive should not apply. It
the
is also appropriate to improve the consistency of
terminology of pharmaceutical legislation.

regulated products,

in particular food,

is necessary,

feed,

(5) OJ L 214, 24.8.1993, p. 1. Regulation repealed by Regulation (EC)
No . . ./2003 of the European Parliament and of the Council (see
page . . . of this Official Journal).

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(8) 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.

(9) The costs of research and development to meet increased
requirements as regards the quality, safety and efficacy of
veterinary medicinal products are leading to a gradual
reduction in the range of products authorised for the
species
smaller market
sectors.

and indications

representing

(10) 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 adequate economic interest
for the veterinary
medicinal products industry.

(11) 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-
the absence of authorisation to
portionate. Moreover,
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.

(12) 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
this procedure and by
up a coordination group for
defining its operation so as
to settle disagreements
within the framework of a revised decentralised 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.

(14) Marketing authorisation for 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 author-
isation 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 authorisations. However,

exemptions from this rule should be granted when these
are justified on public or animal health grounds.

risk-benefit balance of

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

time

the

(16) In the veterinary sector, if no medicinal product has been
authorised for a given species or a given disorder, the
possibility of using other existing 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
foodstuffs
produced will be harmless to consumers as regards any
residues of medicinal products.

that guarantee

conditions

that

the

(17) 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 adminis-
trative
be
harmonised.

data-protection vis-à-vis

generics

should

(18) 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 moni-
foodstuffs, particularly through
toring the quality of
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.

(19) Without prejudice to the provisions aimed at guaranteeing
consumer protection, the specific characteristics of homeo-
pathic veterinary medicinal products, and particularly their
use in organic farming, should be taken into account by
establishing a simplified procedure for registration on
terms defined in advance.

(20) In order to increase the information available to users and
to improve consumer protection in the case of
food-
the provisions on the labelling of
producing animals,
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
supplying medicinal
products for pets, on the other hand, should be simplified.

procedures

for

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the

that

active

(21) The quality of veterinary medicinal products manufactured
or available in the Community should be guaranteed by
requiring
substances used in their
composition comply with the principles of good manu-
facturing practice. It has proved necessary to 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 immu-
nological medicinal products should be reviewed in order
to take account of 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.

(22) Pharmacovigilance

and, more

generally, market
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
to
facilities offered by new information technologies
improve exchanges between Member States.

(23) 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 powers
the exercise of
conferred on the Commission (1).

for

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

‘8. Homeopathic veterinary medicinal product:

a

Any veterinary medicinal product prepared from
substances called homeopathic stocks in accordance
procedure
homeopathic manufacturing
with
described by the European Pharmacopoeia or, in the
absence thereof, by the pharmacopoeias currently used
officially in Member States. A homeopathic veterinary
medicinal product may contain a number of principles.

9. Withdrawal period:

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

in excess of

10. Adverse reaction:

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

treatment of disease or

for

HAVE ADOPTED THIS DIRECTIVE:

(e)

the following point shall be inserted:

Article 1

‘17α. Representative of the marketing authorisation holder:

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

1. Article 1 shall be amended as follows:

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

(a) point 1 shall be deleted;

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

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

‘18. Agency:

‘2. Veterinary medicinal product:

The European Medicines Agency established by Regu-
lation (EC) No . . ./2003 (*);

(a) any substance or

presented as having properties
preventing disease in animals; or

combination of
for

substances
treating or

___________
(*) OJ L . . .’

(b) any substance or combination of substances which
may be used in, or administered to, animals with a
to
view to making a medicinal diagnosis, or
restoring, correcting or modifying physiological
functions.’;

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

‘19. Risks relating to the use of the product:

Any risk relating to the quality, safety or efficacy of the
veterinary medicinal product as regards animal or
human health.’;

(c) point 3 shall be deleted;

(h) the following points shall be added:

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

‘20. Risks relating to the environment:

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

Any risk of unwanted effects on the environment.

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21. Risk-benefit balance:

An evaluation of the positive therapeutic effects of the
veterinary medicinal product in relation to the risks as
defined in point 19.

22. Veterinary prescription:

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

23. 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
accompanied by a
trademark or the name of the marketing authorisation
holder.

scientific name

24. Common name:

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

25. Strength:

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

26. Immediate packaging:

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

27. Outer packaging:

The packaging into which is placed the immediate
packaging.

28. Labelling:

Information on the immediate or outer packaging.

29. Package leaflet:

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

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

‘Article 2

In cases of doubt, where a product falls within the
2.
definition of “veterinary medicinal product” this Directive
shall apply, even in cases where the product also falls
within the scope of other Community legislation.

Notwithstanding paragraph 1,

3.
this Directive shall
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 additives covered by Council Directive 70/524/EEC
of 23 November 1970 concerning additives in feed-
ingstuffs (**) where they are incorporated 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

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

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.

(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

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(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.’;

the products

territory,

in their

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

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.

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 1993 establishing the identification document
(passport) accompanying registered equidae (*), as not
being intended for slaughter for human consumption.
Such veterinary medicinal products shall neither include
active substances that appear 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 Characteristics, for which a veterinary
medicinal product is authorised for animals of the equidae
family.

___________
(*) 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).’;

‘Article 5

5. Article 8 shall be replaced by the following:

1.
No veterinary medicinal product may be placed on
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 . . ./2003.

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

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

‘Article 8

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

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
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.’;

that

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
the
nonfood-producing species, by way of exception,
veterinarian
direct
personal responsibility and in particular to avoid causing
unacceptable suffering, treat the animal concerned with:

responsible may,

his/her

under

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(a) a veterinary medicinal product authorised in the
Member State concerned under
this Directive or
under Regulation (EC) No . . ./2003 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
. . ./2003, or

(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

(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
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, paragraph 1
of this Article shall also apply to the treatment by a veter-
inarian of an animal belonging to the equidae family
provided that it has been declared,
in accordance with
Commission Decision 93/623/EEC, as not being intended
for slaughter for human consumption.

3.
By way of derogation from Article 11, and in
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
Decision 93/623/EEC.

Article 11

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 . . ./2003 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 . . ./2003, 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
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.
Paragraph 1 shall apply provided that pharmaco-
logically active substances
included in the medicinal
to Regulation
product are listed in Annex I,
(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:

— 7 days for eggs,

— 7 days for milk,

— 28 days for meat from poultry and mammals including

fat and offal,

— 500 degree-days for fish meat.

these

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

the date of examination of

3. 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,

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States

4. Without prejudice to the other provisions of this
Directive, Member
all necessary
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 . . ./2003, 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
the establishment of
application has been made for
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.

However,
in the case of veterinary medicinal products
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 an

2.
applicant established in the Community.

The application for marketing authorisation shall
3.
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
the following
Annex I and shall contain,
information:

in particular,

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

(b) name of veterinary medicinal product;

(c) qualitative and quantitative particulars of all

the
constituents of
the veterinary medicinal product,
international non-proprietary name
including
(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,

— safety tests and residue tests,

— pre-clinical and clinical trials;

(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;

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
the
Directive
summary of the product characteristics proposed by
the applicant
in accordance with Article 14 or
approved by the competent authority of 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;

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(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
in
included,
substances not yet
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.

Article 13

(j) of

By way of derogation from point

the first
1.
subparagraph of Article 12(3), and without prejudice to
the law relating to the protection of
industrial and
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;

(b) “generic medicinal product” shall mean a medicinal
product which has the same qualitative and quanti-

the

form as

and whose

bio-equivalence with

appropriate bioavailability

tative composition in active substances and the same
reference medicinal
pharmaceutical
product,
the
reference medicinal product has been demonstrated
studies.
by means of
isomers, mixtures of
Different salts, esters, ethers,
isomers,
an active
complexes or derivatives of
substance shall be considered to be the same active
substance, unless they differ significantly in properties
with regard to safety and/or efficacy. Bioavailability
studies need not be required of the applicant if he
can demonstrate that the generic medicinal product
meets the relevant criteria as defined in the appropriate
detailed guidelines.

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-
istration vis-à-vis the reference medicinal product,
the
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 certain conditions in
in
the definition of generic medicinal products, owing,
particular,
to differences in manufacturing processes of
the biological veterinary medicinal product and the
the
reference biological veterinary medicinal product,
results of appropriate pre-clinical
trials
tests or clinical
relating to these conditions must be provided. The
results of other
from the reference
medicinal product's dossier need not be provided.

tests and trials

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

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.

6.
Conducting the necessary studies, tests and trials with
a view to the application of paragraphs 1 to 5 to a generic
medicinal
practical
the
requirements shall not be regarded as contrary to patent-
related rights or to supplementary-protection certificates
for those medicinal products.’;

consequential

product

and

(*) The date of the entry into force of this Directive.

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7. the following Articles shall be inserted:

Article 13d

‘Article 13a

(j) of

By way of derogation from point

1.
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 substances of
the veterinary medicinal product
have been in well-established veterinary use within the
ten years, with recognised
Community for at
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.

trials if he can demonstrate that

least

The assessment

2.
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
together with further
Regulation (EEC) No 2377/90,
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.

2.

3.

4.

name of the veterinary medicinal product followed
by the strength and the pharmaceutical form;

active

substances

qualitative and quantitative composition in terms of
the
and constituents of
the
excipient, knowledge of which is essential
for
proper administration of
the medicinal product.
The usual common name or chemical description
shall be used;

pharmaceutical form;

clinical particulars;

4.1.

target species,

4.2.

indications for use, specifying the target species,

4.3.

contra-indications,

Article 13b

4.4.

special warnings for each target species,

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

4.5.

special
for use,
special precautions
precautions to be taken by the person administering
the medicinal product to the animals,

including

4.6.

adverse reactions (frequency and seriousness),

4.7.

use during pregnancy, lactation or lay,

4.8.

4.9.

interaction with other medicinal products and other
forms of interaction,

amounts
route,

to be administered and administration

4.10. overdose

(symptoms,
antidotes), if necessary,

emergency

procedures,

4.11. withdrawal periods

foodstuffs,
including those for which the withdrawal period is
zero;

the various

for

5.

pharmacological properties:

5.1. pharmacodynamic properties,

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5.2. pharmacokinetic particulars;

6.

pharmaceutical particulars:

6.1.

list of excipients,

6.2. major incompatibilities,

6.3.

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

or when

product

6.4.

special precautions for storage,

6.5. nature and composition of immediate packaging,

6.6.

for

special precautions
the disposal of unused
veterinary medicinal products or waste materials
derived from the use of such products,
if appro-
priate;

7.

8.

9.

marketing authorisation holder;

marketing authorisation number(s);

date of the first authorisation or date of renewal of
the authorisation;

10.

date of revision of the text.

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.

Article 16

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
legislation on or before 31
accordance with national
December 1993.

By way of derogation from Article 10, homeopathic
3.
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-
producing species
constituents of which
active
to Regulation (EEC) No 2377/90
appear in Annex II
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

9. Article 17 shall be amended as follows:

(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.

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).

the time of

shall
At
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:

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

for

‘— manufacturing and control

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

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

Article 23

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

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

(c) the following eighth indent shall be added:

‘— proposed withdrawal period together with all

requisite justification.’;

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;

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
a valid
the
within 210 days
application.

submission of

after

for

testing by

2. may submit the medicinal product, its starting materials
and if necessary intermediate products or other
constituent materials
an Official
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
documents,
in accordance with point (i) of the first
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
the further data required have been provided.
until
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:

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 25

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.

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

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

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.
authorisation publicly available without delay,
together
with the summary of product characteristics for each
veterinary medicinal product that it has authorised.

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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 concerned. The assessment 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.

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:

to indicate on the

The marketing authorisation may require the
‘1.
holder
immediate packaging
and/or the outer wrapping and the package leaflet,
where the latter is required, other particulars essential
for safety or health protection,
including any special
precautions relating to use and any other warnings
resulting from the clinical and pharmacological 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 auth-
orisation shall be linked to the annual reassessment of
these conditions.’;

15. Article 27 shall be amended as follows:

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

The

competent

authority may

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

the substances

require

At the competent authority's request, the marketing
technical
authorisation holder
the
expertise

shall provide his
the

implementation of

to facilitate

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

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
data demonstrating that
risk-benefit balance
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

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.

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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.’;

(a) the risk-benefit balance of

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

application concerns

17. Article 28 shall be replaced by the following:

‘Article 28

(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

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

to paragraphs 4 and 5,

a

(c)

its qualitative or quantitative composition is not as
stated; or

The authorisation may be renewed after five years on

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

To this end,
the marketing authorisation holder shall
submit a consolidated version of the file in respect of
quality,
including all variations
authorisation was
the marketing
introduced
granted, at least six months before the marketing author-
isation ceases to be valid in accordance with paragraph 1.

safety and efficacy,

since

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

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.

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
consecutive years,
that
the authorisation granted for
veterinary medicinal product shall cease to be valid.

(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.

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.

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:

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.’;

‘CHAPTER 4

Mutual
procedure’;

recognition procedure

and decentralised

18. Article 30 shall be replaced by the following:

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

‘Article 30

‘Article 31

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 examination
of the documents and particulars listed in Articles 12 and
13(1), it is clear that:

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.

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The coordination group shall be composed of one
2.
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
one Member State,
an
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.

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

If

the

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
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
assessment
report. The reference Member State shall
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.

approve

receipt of

4. Within 90 days after
the documents
referred to in paragraphs 2 and 3, the Member States
the
the
concerned shall
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

in which an application
5.
following paragraph 1 has been submitted shall adopt a
decision in conformity with the approved assessment
report, summary of product characteristics,
labelling and
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

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

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

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.

As soon as the applicant has been informed that the
5.
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

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Article 34

a

for

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

the Commission, or

“the Committee”,

referred to as

for

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 (*), a list
of veterinary medicinal products for which a harmonised
summary of product characteristics should be prepared.

authorised

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
Committee
inform the
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.

(*) One year after the entry into force of this Directive.

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

in
However,
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.

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

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

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— the

authorisation should be

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

granted subject

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

21. Article 38 shall be amended as follows:

— a marketing authorisation should be suspended, varied

or revoked.

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

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 . . ./2003. 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
applicant or
together with a report
marketing authorisation holder,
the veterinary medicinal
describing the assessment of
product and the reasons for its conclusions.

the Commission and the

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;

‘1.
The Commission shall take a final decision in
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
a written request
the draft decision be
that
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
or
reference Member
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

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

22.

in Article 39, the third subparagraph of paragraph 1 shall
be deleted;

(d) drafts of the labelling and package leaflet.

23.

in Article 42, paragraph 2 shall be replaced by the
following:

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

At

least every ten years

the Commission shall
‘2.
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.’;

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 reasons for the
differences.

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.

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

30.

in Article 54, paragraph 1 shall be replaced by the
following:

25.

in Article 44, the following paragraph shall be added:

‘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).’;

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.’;

26.

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

31.

in Article 55, paragraph 1(b) 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
include the complete or partial manufacture or
the
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
progress
adopted in accordance with the
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.’;

‘(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

Except in the case of the medicinal products
‘1.
referred to in Article 17(1),
competent
authority shall approve the immediate packaging
and outer packaging of veterinary medicinal
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,
legible
shall
characters:’;

appear

and

the

in

(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
the
common names;’;

volume or weight, using

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(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
appropriate, of the representative designated
by the marketing authorisation holder;’;

The particulars mentioned in the third and sixth
3.
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.’;

34. Article 60 shall be replaced by the following:

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

‘Article 60

‘(g)

for

the withdrawal
medicinal products
food-producing species,
concerned and for
concerned (meat
honey),
drawal period is zero;’;

period
veterinary
to be administered to
the species
foodstuffs
eggs, milk,
including those for which the with-

for all
the various

and offal,

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:

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

(a) paragraph 1 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, the words “For animal treatment
only — to be supplied only on veterinary
prescription”.’;

(b) the following paragraph shall be added:

that

‘5.
In the case of medicinal products that have been
granted a marketing authorisation under Regulation
(EC) No . . ./2003, Member States may permit or
require
the outer packaging bear additional
information concerning distribution, possession, sale
or any necessary precautions, provided that
such
in infringement of Community
information is not
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

packaging
‘2.
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

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
languages of
in which the
medicinal product is marketed.

and in the official

the Member

State

from being written in several

The first subparagraph shall not prevent the package
leaflet
languages,
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

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(ii) Points

(a) and (b)

shall be replaced by the

(a) the following paragraph shall be inserted:

following:

‘(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
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:

‘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.’;

(b) the following paragraph shall be inserted:

‘5.
Any distributor, not being the marketing author-
isation 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 . . ./2003, the notification to the
competent authority shall be without prejudice to
additional procedures provided for in the legislation
of that Member State.’;

‘Article 62

40. Article 66 shall be amended as follows:

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 homeopathic
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
If
of Article 1.
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’;

(a) paragraph 2 shall be amended as follows:

(i) The introductory wording shall be replaced by the

following:

Any person permitted under paragraph 1 to
‘2.
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.’;

(b) paragraph 3 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
provisions of national
law. This provision shall not
apply to the supply of veterinary medicinal products
for
treatment of bacterial
infections.’;

the oral or parenteral

the Commission of

to qualifications,

shall notify

39. Article 65 shall be amended as follows:

(c) paragraph 4 shall be deleted;

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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:

‘Without prejudice
to stricter Community or
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

Member States may continue
national provisions until either:

to apply

(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;’;

tration, including when the animal is slaughtered during
the five-year period.’;

43. the introductory wording of Article 70 shall be replaced

by the following:

‘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.’;

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

46. Article 73 shall be amended as follows:

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

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

‘(d) officinal

formulae, within the meaning of
intended for food-producing

Article 3(2)(b),
animals.’;

(b) the

second paragraph shall be

replaced by the

following:

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
therapy
the
amount
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.’;

42. the first paragraph of Article 69 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-

reactions

decisions

regulatory

concerning

suspected adverse

‘In order to ensure the adoption of appropriate and
the
harmonised
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
veterinary medicinal
particular
reference to adverse reactions
in animals and in
relating to the use of veterinary
human beings
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 . . ./2003 and shall be permanently accessible
to all Member States and without delay to the public.’;

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47. 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:’;

48. 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,
and no later
the
information.

than 15 days following receipt of

authority of

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

Unless other requirements have been laid down as a
5.
condition for the grant of 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, either immediately upon request or period-
ically as follows: six monthly for the first two years after
authorisation, annually for the subsequent two years, and
thereafter at three-yearly intervals.

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

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

The holder of a marketing authorisation may not
8.
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.

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

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
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.

territory of

a

4.
By way of derogation from paragraphs 2 and 3, in
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

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.’;

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

shall

in collaboration with Member States
‘1.
The Agency,
set up a data-processing
and the Commission,
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.’;

50.

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.

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

51. Article 78 shall be amended as follows:

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

or

animal

If urgent action is necessary for protecting
‘2.
human
State
health,
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
medicinal
is marketed to take temporary measures
immediately.

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

52. Article 80 shall be amended as follows:

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

The competent authority of the Member State
‘1.
concerned shall
repeated
inspections and, if necessary, unannounced inspections,
that
relating to veterinary
medicinal products are complied with.

ensure, by means of

requirements

the legal

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
the marketing
it
considers
suspecting
that
non-compliance with the provisions of Article 51.
the
Such inspections may also be carried out at
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
Pharmacopoeia (*)
elaboration
(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;

(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-
the content of
isation holder shall be informed 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.

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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

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

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

concerned,

The competent authority shall notify the other Member
States
the
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

53. 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

If a competent authority concludes that a batch of a
veterinary medicinal product is not in conformity with
the control report of the manufacturer or the specifications
provided for in the marketing authorisation, it shall take
all the necessary measures vis-à-vis the marketing author-
isation holder and the manufacturer, where appropriate,
and shall inform accordingly the other Member States in
which the veterinary medicinal product is authorised.’;

54. Article 83 shall be amended as follows:

(a) paragraph 1 shall be amended as follows:

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

The competent authority shall
the other
Member States in which the veterinary medicinal 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

3.
After studying the control reports referred to in
Article 81(2), the laboratory responsible for the control
the tests
shall
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-
the list of
orised under Regulation (EC) No . . ./2003,
laboratory may be
tests to be repeated by the control
reduced only after agreement by the Agency.

All Member States concerned shall recognise the

4.
results of the tests.

(i) The introductory words shall be replaced by the

following:

‘1. Member States' competent authorities shall
suspend,
revoke, withdraw or vary marketing
authorisations when it is clear that:’;

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

‘(a)

the risk-benefit assessment of the veterinary
is, under the authorised
medicinal product
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.’;

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Official Journal of the European Union

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(b) paragraph 2 shall be amended as follows:

58. Article 90 shall be replaced by the following:

(i) The introductory words shall be replaced by the

following:

‘Article 90

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

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

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

‘(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);’;

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

55.

in Article 84, point (a) of paragraph 1 shall be replaced by
the following:

‘(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
authorisation concerns
veterinary medicinal product for zootechnical use.’;

56.

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.’;

57.

in Article 89, paragraphs 2 and 3 shall be replaced by the
following:

reached following an inspection as
The conclusions
referred to in Article 80(1) carried out by the inspectors
of
the Member State concerned shall be valid for the
Community.

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

When the Commission is
such serious
it may, after consulting the Member States
reasons,
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.’;

59.

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.’;

60. Article 95 shall be replaced by the 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.

‘Article 95

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.

The Standing Committee shall adopt

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

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.’;

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61. the following Article shall be inserted:

‘Article 95a

When a veterinary medicinal product is to be authorised in
accordance with Regulation (EC) No . . ./2003 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
that Regulation, a
provided for in Article 34(4)(d) of
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.’.

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.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Article 2

Done at . . .

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
immediately
Directive by . . . (*) at
inform the Commission thereof.

the latest. They shall

For the European Parliament

For the Council

The President

The President

(*) 18 months after entry into force of the Directive.

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 26 November 2001, the Commission submitted a proposal for a Directive relating to veterinary

medicinal products to the Council and to the European Parliament (1).

The proposal is based on Articles 95 and 152(4)(b) of the Treaty.

The proposal, together with a proposal for a Regulation on Community procedures for the auth-
orisation and supervision of medicinal products and establishing a European Agency for the
for a Directive relating to
Evaluation of Medicinal Products (the ‘Regulation’) and a proposal
medicinal products for human use (the ‘human Directive’),
is part of a review of Community
legislation on medicinal products.

2. The European Parliament adopted its first-reading opinion on 23 October 2002 (2). The Commission

subsequently presented an amended proposal on 3 April 2003 (3).

3. The Economic and Social Committee adopted its opinion on 16 January 2002 (4).

4. On 29 September 2003, the Council adopted its common position in accordance with Article 251

of the Treaty.

II. AIM

The principal objectives of the three proposals making up the review of Community legislation are:

— to ensure that Community legislation can respond to new challenges, particularly the development

of new therapies, and thus to safeguard a high level of health protection in Europe;

— to ensure the proper operation of the internal market both before and after enlargement of the

European Union;

— to enhance the competitiveness of the European pharmaceutical industry, to enable it better to meet

the challenges of globalisation; and

— to improve the transparency of procedures and decisions.

III. ANALYSIS OF THE COMMON POSITION (5)

The common position is consistent with the aims listed above.

However, the Council has made a number of changes compared to the Commission's original proposal,
which the Commission has been able to accept. In addition to the changes of substance discussed
below, the common position incorporates a number of editorial and technical changes:

— to clarify certain provisions (6);

— to ensure internal consistency (7);

(1) OJ C 75 E, 26.3.2002, p. 189.
(2) Not yet published in the Official Journal.
(3) COM(2003) 163 final.
(4) OJ C 61, 14.3.2003, p. 1.
(5) References to numbered Articles refer to the Articles of Directive 2001/82/EC as amended.
(6) This includes changes consistent with European Parliament amendments 1, 19, 20 and 39 (recital 3 and Articles 14

and 61(2)).

(7) This includes changes consistent with the aim of European Parliament amendment 57 (recital 14) and part of

amendment 11 (Article 11(1)).

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— to update terminology; and

— to align the provisions of the Directive with those of the Regulation and the human Directive (1).

The common position does not purport to amend the legal basis of Directive 2001/82/EC, since the
Council considers that this is neither necessary nor appropriate.

To increase the availability of veterinary medicinal products, the Council has widened the scope of
the ‘cascade’ procedure for food-producing animals (Article 11(1)). The scope of the procedure would
in fact be the same in principle for all animals, but additional safeguards,
in particular as regards
withdrawal periods, would remain in place for food-producing animals.

In Article 67, which specifies those veterinary medicinal products that are to be available only on
prescription, point (d) no longer contains a reference to the magistral formula. This was superfluous,
since the magistral formula by definition requires a veterinary prescription. To be consistent with the
rule for authorised veterinary medicinal products, veterinary prescription would be necessary for
veterinary medicinal products prepared in accordance with the officinal formula only when destined
for food-producing animals.

As regards food from test animals, the common position provides two options for withdrawal
periods. In addition to reinstating the existing provision of Article 95, which deals only with cases
where maximum residue limits have been established, it provides for the use of the withdrawal periods
set out in Article 11(2) as an alternative.

A. European Parliament amendments accepted in full

The Council has accepted amendment 16. The common position would therefore allow manu-
facturers of generic veterinary medicinal products to submit an application 8 years after the
granting of the marketing authorisation for the reference product. It would permit the placing on
the market of authorised generics 10 years after the granting of the marketing authorisation for the
reference product.

The Council has accepted amendments 26, 29, 36 and 49, which concern transparency, and
included them in its common position with some drafting changes (2).

The common position also incorporates:

— amendments 31 to 35, which concern the mutual recognition procedure (Articles 34 to 36);

— amendment 42 on prescriptions (Article 67);

— amendment 46 on the inspection of premises (Article 80(1)); and

— amendment 48 on advertising (Article 85(3)).

B. European Parliament amendments accepted in part or in principle

The common position is consistent with the principle of a number of amendments that have the
aim of increasing the availability of veterinary medicinal products, namely:

— amendments 8 and 9, since the same cascade procedure would apply to all non food-producing
animals and would permit the exceptional use of veterinary medicinal products authorised for
use with another animal species or for another condition in the same species, including those
authorised in another Member State (Article 10);

— amendments 17 and 18, because it provides for additional commercial incentives by widening the
circumstances in which extended data-protection periods would be available (Article 13);

(1) In particular, Articles 26(3), 28 and 36(5) are consistent with the corresponding provisions of both the Regulation
and the human Directive, while Articles 3(1)(e), 13, 13a, 13b, 14, 27a, 32(2), 34, 38, 61(1), 75 and 95a are
consistent with the corresponding provisions of the human Directive.

(2) Articles 25(4), 31(3), 42(2) and 89(4).

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— amendments 52 and 53, as it would establish simplified procedures for the administration of

homeopathic veterinary medicinal products (Article 16); and

— amendment 65, in that it provides a derogation from the requirement to establish maximum
residue limits for animals of the equidae family that are not intended for slaughter for human
consumption (Article 6(3)).

the validity of

As concerns the renewal of marketing authorisations, the Council has accepted the principle of
amendment 58 (Article 28). It agrees that there should be one renewal after a five-year period and
that, after that,
the marketing authorisation ought generally to be unlimited.
However, the Council believes that it would be administratively simpler for the 5-year period to
start running on the date of the marketing authorisation. In addition, the Directive should, like the
Regulation and the human Directive, enable the competent authority to require one extra five-year
this
renewal
addition would provide the competent authority with an extra tool
to ensure the effective
surveillance of authorised products.

to take place on justified pharmacovigilance grounds. The Council believes that

The common position is also consistent with the principle of:

— amendments 4 and 41 concerning the definition of a ‘homeopathic veterinary medicinal product’

and the labelling of such products (Articles 1(8) and 64(2));

— amendment 5, since it clarifies the definitions of risks and of the risk-benefit balance (Article

1(19), (19a) and (19b));

— amendments 14, 15 and 68, because it would require all applications for marketing author-
isations to include information on pharmacovigilance and potential risks to the environment
(Article 12(3)(g), (k) and (o));

— amendment 28 as regards the ‘sunset clauses’ for authorised veterinary medicinal products that

are never placed on the market or cease to be placed on the market (Article 28); and

— amendment 62, in that it provides for the modification of the minimum withdrawal periods
specified for the cascade procedure if there are valid reasons for such modification (Article
11(2)).

C. Unacceptable European Parliament amendments

The Council cannot accept three amendments relating to the prescription of veterinary medicinal
products: amendments 43, 44 and 67.

It cannot accept amendment 67, since it would place undue restrictions on the definition of a
‘veterinary prescription’. Instead, the Council agrees with the Commission that Directive 2001/82/EC
should contain a definition of ‘veterinary prescription’ corresponding to the definition of ‘medical
prescription’
the common position states
explicitly that national law will specify which are the professional persons qualified to issue such
prescriptions. While this person will very often be a veterinarian, it would not be appropriate to
exclude the possibility of other professional qualified persons delivering prescriptions in certain
circumstances.

in Directive 2001/83/EC. To clarify the definition,

Although the Council agrees that Article 67 ought to establish the general principle that veterinary
into the category of veterinary medicinal
medicinal products for food-producing animals fall
products available only on prescription but provide for exceptions,
it cannot accept
amendment 43. Since there is free movement of live animals and food within the Community,
the Council believes that
is desirable to have harmonised rules for exemptions from the
general principle. The common position therefore provides for the adoption of harmonised
criteria through comitology by 31 December 2006.

it

While it cannot accept detail of amendment 44, the Council has reduced the period during which all
veterinary medicinal products containing new active substances must be available only on
prescription from seven to five years.

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The Council could not accept a number of amendments relating to homeopathic veterinary
medicinal products.

— It believes that there is no need to reinstate the current requirement for Member States to take
due account of products that other Member States register or authorise, since this would not
create any legal requirement for Member States to recognise each other's actions (amendment 21).

— It considers that ‘potentisation’ is not the correct terminology in this context (amendments 22 and

24) as potentisation and dilution are different operations.

Finally, the Council has not incorporated into its common position several other amendments that the
Commission could not accept for the reasons given in its modified proposal (1).

(1) Amendments 2, 3, 7, 10, 13, 23, 25, 27, 30, 37, 38, 40, 45, 47, 56, 59, 60, 63, 64, 66 and 69.