Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products
Date: 2001-11-26
Institutions: European Commission
Subjects: drug surveillance, market approval, pharmaceutical legislation, veterinary drug

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Proposal for a Directive of the European Parliament and of the Council amending Directive
2001/82/EC on the Community code relating to veterinary medicinal products

(2002/C 75 E/14)

COM(2001) 404 final (cid:151) 2001/0254(COD)

(Submitted by the Commission on 26 November 2001)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

industry or
Community.

trade in medicinal products within the

Having regard to the Treaty establishing the European
(b) of
Community, and in particular Article 95 and point
Article152(4) thereof,

Having regard to the proposal of the Commission,

Having regard to the opinion of
Committee,

the Economic and Social

Having regard to the opinion of the Committee of the Regions,

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

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, in the interests
of clarity and rationalisation, has codified and combined
in a single text the texts of Community legislation on
veterinary medicinal products.

(2) Community legislation constitutes an important stage in
the achievement of the objective of free movement of
veterinary medicinal products. However, new measures
prove necessary in the light of the experience gained,
particularly in the Committee for veterinary medicinal
products, with a view to eliminating the remaining
obstacles to free movement.

(3) It is therefore necessary to align the national laws, regu-
and administrative provisions which contain
lations
differences with regard to the basic principles in order
to promote the operation of the internal market.

should be

authorisations

(4) Any regulations on the production and distribution of
veterinary medicinal products
essentially
aimed at safeguarding public health. The legislation on
marketing
veterinary medicinal
products, and the criteria governing the grant of author-
isations, are such as to strengthen the protection of public
health within the meaning of point (b) of Article 152(4)
of the Treaty, as inserted by the Treaty of Amsterdam.
That aim should, however, be achieved by means that
will not impede the development of the pharmaceuticals

for

(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 (1)
Agency for
provides that, within six years of
its entry into force,
the Commission is 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
gained, it has proved necessary to improve the operation
of the marketing authorisation procedures for medicinal
products in the Community.

the growing number of

(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
ensure a high level of requirements as to the quality,
safety and efficacy of veterinary medicinal products. In
order to take account, both of the emergence of new
therapies and of
so-called
(cid:145)borderline(cid:146) products between the medicinal product
sector and other
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, taking into account the characteristics of the phar-
maceutical legislation, it is proposed that such legislation
this
is to apply.
opportunity to improve the consistency of
the termi-
nology of pharmaceutical legislation.

is also worth taking advantage of

sectors,

It

(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 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
representing smaller market
species
sectors.

and indications

(1) OJ L 214, 24.8.1993, p. 1; Regulation as amended by Commission

Regulation (EC) No 649/98 (OJ L 88, 24.3.1998, p. 7).

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(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 of food-
producing animals on terms that guarantee a high level of
that provides
consumer protection, and in a context
adequate economic interest for the veterinary medicinal
products industry.

marketing authorisation holder of a veterinary medicinal
product and the competent authorities in charge of moni-
foodstuffs, particularly through
toring the quality of
compliance with the provisions on the use of
these
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 might be produced by the animals involved in the
tests.

provisions

(11) In certain circumstances, particularly where new types of
pets are concerned, the need to obtain a marketing auth-
orisation for a veterinary medicinal product in accordance
unjustified.
with Community
is
the absence of authorisation to market an
Moreover,
immunological product
in the Community should not
be an obstacle to international movements of certain
live animals for which binding health measures have to
be taken for this purpose. The provisions on the author-
isation 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.

clearly

(12) An assessment of the operation of the procedures for the
granting of market authorisation has revealed the need to
revise, in particular, the mutual recognition procedure in
to increase the scope for cooperation between
order
Member States. This cooperation process
should be
formalised by setting up a coordination group and
defining its role in settling disagreements, in the context
of a revised decentralised procedure.

(13) Except in special circumstances, marketing authorisations
should be granted for an unlimited period and, in parallel,
the procedures for monitoring products actually being
marketed should be strengthened.

(14) In the veterinary sector, if no medicinal product has been
authorised for a given species or a given disorder, the use
of other existing products should be made a straight-
forward matter, but without prejudice to consumer
health in the case of medicinal products intended for
administration to food-producing animals.

(15) 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 data-protection vis-(cid:224)-vis generics needs
to be
harmonised and extended, subject to certain conditions.

(16) There is also a need to clarify the obligations of, and
division of responsibilities between, the applicant for or

(17) Without prejudice to the provisions aimed at guaranteeing
characteristics of
specific
the
consumer protection,
and
veterinary medicinal
homeopathic
farming, should be
particularly their use in ecological
taken
simplified
account
procedure for registration on terms defined in advance.

establishing

products,

into

by

a

leaflet

(18) In order to increase the information available to users and
to improve consumer protection in the case of
food-
producing animals,
the provisions on the labelling of
veterinary medicinal products and the accompanying
strengthened. The
package
requirement
that a veterinary medicinal product may
only be dispensed after a veterinary prescription has
been made out should also be extended to all medicinal
products for food-producing animals. The administrative
procedures for supplying medicinal products for pets
should, on the other hand, be simplified.

also be

should

also need to be

(19) The quality of the veterinary medicinal products manu-
factured or available in the Community should be
guaranteed by requiring that the active substances they
contain have been produced in accordance with good
manufacturing practice. The Community provisions on
inspections
and a
Community register established containing the results of
these inspections. The arrangements for the official release
of batches of certain immunological medicinal products
should be reviewed in order to take account of
the
improvement of the general system for monitoring the
technical
quality of medicinal products and to reflect
and scientific progress, and also in order
to make
mutual recognition fully effective.

strengthened,

(20) The monitoring of the efficacy and safety of the veterinary
medicinal products on the market should be improved by
stepping up pharmacovigilance measures, particularly
where the validity of marketing authorisations is no
longer compulsorily limited to five years. The frequency
with which the periodical
safety update reports are
submitted should be increased, there should be an oper-
ational network for the exchange of electronic data and,
where appropriate, the competent authorities should be
enabled to take temporary emergency measures.

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(21) Since most of the measures necessary for the implemen-
tation of this Directive are measures of individual scope,
use should be made of the advisory procedure provided
for in Article 3 of Council Decision 1999/468/EC of
the
28 June 1999 laying down the procedures
exercise of
conferred on the
implementing powers
Commission (1), or of the management procedure under
Article 4 thereof. As regards general scope within the
meaning of Article 2 of the Decision, those measures
should be adopted by use of the regulatory procedure
provided for in Article 5 thereof.

for

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

substances laid down in Annex I or III to Regu-
lation (EEC) No 2377/90.

10. Adverse reaction:

normally

A reaction to a veterinary medical product which
is harmful and unintended and which occurs at
doses
the
prophylaxis, diagnosis or treatment of disease or
to restore, correct or modify a physiological
function.(cid:146)

animals

used

for

in

(e) The following points 20 to 27 are added:

HAVE ADOPTED THIS DIRECTIVE:

(cid:145)20. Veterinary prescription

Article 1

Directive 2001/82/EC is amended as follows:

1. The first citation is replaced by the following:

(cid:145)Having regard to the Treaty establishing the European
Community, and in particular Article 95 and point (b) of
Article 152(4) thereof,(cid:146)

2. Article 1 is amended as follows:

(a) Point 1 is deleted.

(b) Point 2 is replaced by the following:

(cid:145)2. Veterinary medicinal product

Any substance or combination of substances

(a) presented for treating or preventing disease in

animals;

(b) capable of use in animals with a view to
making a medical diagnosis or to restoring,
correcting
physiological
functions in animals.(cid:146)

modifying

or

(c) Point 3 is deleted.

prescription

Any
issued
products
qualified to do so.

for

by

a

veterinary medicinal
person
professional

21. Name of veterinary medicinal product

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

22. Non-proprietary name

The international name recommended by the
World Health Organisation or,
the
common name.

failing this,

23. Strength

The content of active substances, expressed as
quantity per unit, per unit volume or per unit
is
weight, depending on how the product
presented.

24. Immediate packaging

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

(d) Points 9 and 10 are replaced by the following:

25. Outer packaging

(cid:145)9. Withdrawal period

Period necessary between the last administration of
the veterinary medicinal product to animals, under
normal conditions of use and in accordance with
good veterinary practice, and the production of
foodstuffs from such animals, in order to protect
public health, by ensuring [follow on] that such
foodstuffs do not contain residues in quantities in
the maximum residue limits of active
excess of

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

packaging

The
packaging is placed.

into which

the

immediate

26. Labelling

The words printed on the outside or immediate
packaging.

27. Package leaflet

The leaflet containing information for the user
that accompanies the medicinal product.(cid:146)

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3. Articles 2 and 3 are replaced by the following:

(cid:145)Article 2

this Directive shall apply to
The provisions of
1.
veterinary medicinal products
for
including pre-mixes
medicated feeding stuffs intended to be placed on the
market in the Member States and prepared industrially or
by a method involving an industrial process.

2.
The provisions of this Directive shall apply whenever
a substance or composition of substances corresponds to
the definition of a medicinal product, even if the substance
or composition of substances is also falling within the field
of application of other Community legislation.

Article 3

1.

This Directive shall not apply to:

(a) medicated feedingstuffs as defined in Council Directive

90/167/EEC (*);

(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 radioactive

isotopes;

(d) any

covered

Directive
additives
70/524/EEC (**) where
incorporated in
they
animal feedingstuffs and supplementary animal feed-
ingstuffs in accordance with that Directive.

Council

are

by

However, medicated feedingstuffs under point (a) may be
prepared only from pre-mixes which have been authorised
under this Directive.

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

(a) any medicinal product prepared in a pharmacy in
accordance with a prescription for an individual
animal, commonly known as the magistral formula;

(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.(cid:146)

4. Article 4(2) is replaced by the following:

(cid:145)2. Member States may permit exemptions on their
territory in respect of veterinary medicinal products

intended solely for aquarium fish, ornamental birds,
terrarium animals, small rodents, and
homing pigeons,
from the
ferrets and rabbits kept exclusively as pets
provisions
such
products do not contain substances the use of which
requires veterinary control and that all possible measures
have been taken to prevent unauthorised use of
the
products for other animals.(cid:146)

in Articles 5 to 8, provided that

5. Articles 5 and 6 are replaced by the following:

(cid:145)Article 5

1.
No veterinary medicinal product may be placed on
the market of a Member State unless a marketing author-
isation has been issued by the competent authorities of
that Member State in accordance with this Directive or a
marketing authorisation has been granted in accordance
with Regulation (EEC) No 2309/93.

strengths, pharmaceutical

The various
forms, adminis-
tration routes, presentations and any amendment under
Article 39 must be authorised under the first subparagraph
and shall be considered part of the same authorisation.

The holder of the marketing authorisation shall be

2.
responsible for the marketing of the medicinal product.

Article 6

1.
In order that a veterinary medicinal product may be
the subject of a marketing authorisation for the purpose of
administering it to one or more food-producing species,
the pharmacologically active substances which it contains
must be shown in Annexes I, II or III to Regulation (EEC)
No 2377/90.

2.
If it is justified by an amendment to the Annexes to
Regulation (EEC) No 2377/90, the holder of the marketing
authorisation or, where appropriate, the competent auth-
orities shall take all necessary measures for amending or
withdrawing the marketing authorisation within 60 days of
the date on which the amendment
to the Annexes to
Regulation (EEC) No 2377/90 was published in the
Official Journal of the European Communities.(cid:146)

6. Article 8 is replaced by the following:

(cid:145)Article 8

allow the use of

In the event of serious epizootic diseases, Member States
immunological
may provisionally
veterinary medicinal products without an authorisation
for placing on the market,
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.

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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 animal
in question, of a immunological veterinary medicinal
product that is not covered by a marketing authorisation
in the Member State in question but is authorised under
the legislation of the third country. Member States shall
take all appropriate measures concerning the supervision
of the importation and the use of such immunological
products.(cid:146)

7. Articles 10 to 13 are replaced by the following:

(cid:145)Article 10

If

1.
in a
there is no authorised medicinal product
Member State for a condition affecting a species of pet
animal or animals kept in zoos or circuses, the veterinarian
may, particularly in order to avoid causing unacceptable
suffering to the animal concerned, under his/her personal
responsibility, treat the animal(s) with:

(a) a veterinary medicinal product authorised in the
Member State concerned under
this Directive or
under Regulation (EEC) No 2309/93 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), 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 (EEC) No 2309/93; or

(c)

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

2.
By way of derogation from Article 11, the provisions
of paragraph 1 shall also apply to the treatment by a
veterinarian of an animal belonging to the equidae family
provided that
it has been declared, under Commission
Decision 93/623/EEC (*), as never having been intended
for the production of foodstuffs.

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 veterinary
medicinal products essential for the treatment of equidae
and for which the withdrawal period shall be not less
than six months according to the control mechanisms
laid down in Decision 93/623/EEC.

___________
(*) OJ L 298, 3.12.1993, p. 45.

Article 11

1. Where there is no authorised medicinal product for a
condition affecting a food-producing species, Member
States shall, particularly in order to avoid causing unac-
ceptable suffering to the animals concerned, permit the
administration by a veterinarian or under his/her direct
personal
to a small
responsibility to an animal or
number of animals on a particular holding:

(a) of a veterinary medicinal product authorised in the
Member State concerned under
this Directive or
under Regulation (EEC) No 2309/93 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),

(i) either, of a medicinal product authorised for use in
the Member State concerned with human beings in
accordance with Directive 2001/83/EC or under
Regulation (EEC) No 2309/93, or

(ii) of a veterinary medicinal product authorised in
another Member State in accordance with this
Directive for use in the same species for
the
condition in question or for another condition; or

(c)

if the product or products as referred to in point (b)
is/are not available and within the limits of the law of
the Member State concerned, of a veterinary medicinal
product prepared extemporaneously by a person auth-
orised to do so under national legislation in accordance
with the terms of a veterinary prescription.

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

II or III

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

(a) 7 days for eggs;

(b) 7 days for milk;

(c) 28 days for meat from poultry and mammals including

fat and offal;

(d) 500 degree-days for fish meat.

the date of examination of

3. When a veterinarian has recourse to the provisions of
this Article, he/she shall keep
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 make these records
available for inspection by the competent authorities for a
period of at least five years.

the owner,

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concerning

States
the

this
4. Without prejudice to the other provisions of
necessary
Directive, Member
measures
and
dispensing of and information on the medicinal products
which they permit for administration to food-producing
animals
this
Article.

in accordance with paragraph 1(b)(ii) of

all
distribution

shall
import,

take

Article 12

1.
For the purposes of obtaining a marketing auth-
orization in respect of a veterinary medicinal product,
other than under the procedure established by Regulation
(EEC) No 2309/93, an application shall be lodged with the
competent authority of the Member State concerned.

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

limits

A marketing authorization 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 medical 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
constituents of the veterinary medicinal product;

the

(d) description of the method of manufacture;

(e)

(f)

therapeutic indications, contra-indications and adverse
reactions;

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

is intended,

(g)

if applicable, explanations of the precautionary and
safety measures to be taken when the product
is
stored, when it is administered to animals and when

waste therefrom is disposed of, together with an indi-
cation of any potential risks the medicinal product
might pose to the environment and the health of
humans, animals or plants;

(h)

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

for

(i)

description of the testing methods employed by the
manufacturer;

(j)

results of:

(cid:151) pharmaceutical

(physico-chemical, biological or

microbiological) tests;

(cid:151) safety tests and residue tests;

(cid:151) pre-clinical and clinical trials;

(k) 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;

(l)

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

is under

(m) copies of any marketing authorization 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
authorization submitted in accordance with this
Directive
the
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 authorization, whether in the Community or
a third country and the reasons for that decision; all
this information shall be updated on a regular basis;

examination. Copies of

(n)

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

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

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Article 13

(j) of

By way of derogation from point

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

the medicinal product

However,
the ten-year period provided for in the first
subparagraph is extended to 13 years in the case of
veterinary medicinal products for fish or bees.

This period cannot, 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
shall be granted only if the marketing authorisation holder
had also been at the origin of the maximum residue limits
established for the species covered by the authorisation.

5.
Conducting the necessary tests and trial with a view
to application of paragraphs 1 to 4 to a generic medicinal
product shall not be regarded as contrary to patent related
rights and to complementary protection certificates for
those medicinal products.(cid:146)

8. The following Articles 13(a) to 13(d) are inserted:

2.

For the purposes of this Article:

(cid:145)Article 13(a)

(a) reference medicinal product shall mean a product auth-
orised 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-
tative composition in terms of active substances, the
same pharmaceutical form, and whose bioequivalence
with the reference medicinal product has been demon-
strated by means of appropriate bioavailability tests.
the
Bioavailability tests may not be required of
applicant
the
that
can
medicinal product meets the criteria set out in Annex I.

demonstrate

he/she

if

3.
The first subparagraph of paragraph 1 shall not apply
in the event of a change in the active substance or
substances, the therapeutic indications, the strength, the
pharmaceutical form, the route of administration or the
dose vis-(cid:224)-vis the reference medicinal product, and the
results of appropriate safety and residue tests studies and
pre-clinical and clinical trials shall be provided.

In the case of veterinary medicinal products intended
4.
for one or more food-producing species and containing a
new active substance that has not been authorised in the
Community by [date] the ten-year period provided for in
the first subparagraph of paragraph 1 shall be extended by
one year for each extension of the marketing authorisation
to another food-producing species, if it is authorised within
the three years
the initial
marketing authorisation.

following the granting of

The extension of one, two or three years of further data
protection also applies to any initial marketing author-
isation relative to two,
food-producing
species, respectively.

three or

four

(j) of

By way of derogation from point

the safety and residue tests or of

the first
1.
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
the
pre-clinical and clinical trials if he/she can demonstrate
that
the veterinary medicinal
product are of well-established veterinary use for not less
than ten years in the Community, with recognised efficacy
and an acceptable level of safety in accordance with the
conditions set out in Annex I. In that event the applicant
shall provide appropriate scientific documentation.

the active substance(s) of

The assessment

report published by the Agency
2.
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.

a

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

Article 13(b)

In the
case of new veterinary medicinal products
containing active substances used in the composition of
authorised veterinary medicinal products but not hitherto
used in combination for therapeutic purposes, the results
of safety and residue tests and of pre-clinical and clinical
trials relating to that combination shall be provided, but it
shall not be necessary to provide the documentation
relating to each individual active substance.

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Article 13(c)

of

the

pharmaceutical,

After marketing authorisation has been granted,
the
marketing authorisation holder may allow use to be
residues,
made
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

Article 13(d)

(j) of

By way of derogation from point
first
subparagraph of Article 12(3), and in exceptional circum-
stances with respect to immunological veterinary medicinal
products, the applicant shall not be required to provide the
results of certain field trials on the target species if these
trials cannot be carried out for duly substantiated reasons,
in particular on account of other Community provisions.(cid:146)

the

9. Articles 14 and 15 are replaced by the following:

(cid:145)Article 14

The summary of the product characteristics shall contain
the following information:

1. Name of the veterinary medicinal product followed by

the strength and the pharmaceutical form;

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

3. Pharmaceutical form;

4. Pharmacological properties and,

this
information is useful for the therapeutic purposes, phar-
macokinetic particulars;

in so far as

5. Clinical particulars;

5.1.

target species,

5.2.

indications for use, specifying the target species,

5.3.

contra-indications,

5.4.

special warnings for each target species;

5.5.

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

5.8.

interaction with other medicaments and other
forms of interaction;

5.9.

amounts to be administered and administration
route;

5.10. overdose

(symptoms,

emergency

procedures,

antidotes) (if necessary);

5.11. withdrawal periods (expressed in hours or days)
including those for

for the various foodstuffs,
which the withdrawal period is zero.

6. Pharmaceutical particulars:

6.1.

incompatibilities;

6.2. shelf

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

6.3. special precautions for storage;

6.4. nature and composition of immediate packaging;

6.5. special precautions,

including those pertaining to
the environment,
the disposal of unused
for
medicinal products or waste materials derived
from the use of these products, if any.

7. Name, or corporate name, and permanent address or
registered place of business of the marketing author-
isation holder.

Article 15

Applicants shall ensure that the detailed and critical
1.
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-
2.
cations, referred to in paragraph 1, shall
justify any use
made of the scientific literature referred to in Article 13a(1)
in accordance with the conditions set out in Annex I.

3.
A brief curriculum vitae of the persons referred to in
paragraph 1 shall be appended to the detailed critical
summaries.(cid:146)

10. Article 16 is replaced by the following:

(cid:145)Article 16

shall

ensure

that homeopathic
1. Member
States
veterinary medicinal
and
marketed within the Community are registered or auth-
orised in accordance with the provisions of Article 17(1)
and (2), and Articles 18 and 19.

products manufactured

5.6.

adverse reactions (frequency and seriousness);

5.7.

use during pregnancy, lactation or lay;

2. Member States shall establish a simplified registration
procedure
the homeopathic veterinary medicinal
products referred to in Article 17.(cid:146)

for

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11. Article 17 is amended as follows:

(a) Paragraph 1 is replaced by the following:

(cid:145)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, in absence thereof, by
the pharmacopoeias currently used officially in the
Member States;

(b) no specific therapeutic indication appears on the
the veterinary medicinal product or

labelling of
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 either more
than one part per 10 000 of the mother tincture or
more than 1/100th of the smallest dose used in
allopathy with regard to active principles whose
in an allopathic medicinal product
presence
results in the obligation to submit a veterinary
prescription.

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

the time of

At
shall
determine the classification for the dispensing of the
medicinal product.(cid:146)

registration, Member States

(b) Paragraph 3 is deleted.

12. Article 18 is amended as follows:

(a) The sixth indent is replaced by the following:

(cid:145)(cid:151) one or more mock-ups of the outer packaging and
immediate packaging of the medicinal products to
be registered,(cid:146)

(b) The following eighth indent is added:

(cid:145)(cid:151) proposed withdrawal period together with all

requisite justification.(cid:146)

13. Article 19 is replaced by the following:

(cid:145)Article 19

Homeopathic veterinary medicinal products other
1.
than those referred to in Article 17(1) shall be authorised
in accordance with the provisions of Articles 12 to 14.

2.
A Member State may introduce or retain on its
territory specific rules for the safety tests and pre-clinical

trials of homeopathic veterinary medicinal
and clinical
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
In this
homeopathy as practised in that Member State.
case,
concerned shall notify the
Commission of the specific rules in force.(cid:146)

the Member State

14. Articles 21, 22 and 23 are replaced by the following:

(cid:145)Article 21

1. Member States shall take all appropriate measures to
ensure that the procedure for granting an authorisation to
place a veterinary medicinal product on the market
is
completed within 150 days of the submission of a valid
application,
for drawing up the
assessment report and the summary of product charac-
teristics.

including 120 days

With a view to the grant of a marketing authorisation for a
in two or more Member
veterinary medicinal product
States, applications shall be submitted in accordance with
Articles 31 to 43.

2. Where a Member State notes that an application for
authorisation of a given veterinary medical product
submitted is already being examined in another Member
State, the Member State concerned shall decline to assess
the application and shall
inform the applicant that the
procedure described in Articles 31 to 43 applies.

Article 22

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

Article 23

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

the competent authorities of

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;

2. may submit the medicinal product,

its raw materials
and if necessary intermediate products or other
constituent materials for testing by a State laboratory
or by a laboratory designated for that purpose, in order
to ensure that the testing methods employed by the
application
manufacturer
described
documents,
(i) of Article
in accordance with point
12(3), are satisfactory;

and

the

in

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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
in accordance with the
second subparagraph of Article 12(3) is satisfactory;

4. may, where appropriate,

require the applicant

to
provide further information as regards the items listed
in Articles 12 to 13d. Where the competent authorities
take this course of action, the time-limits specified in
Article 21 shall be suspended until the further data
required have been provided. Similarly, these time-limits
shall be suspended for any period which the applicant
may be given to provide oral or written explanations.(cid:146)

15. In Article 25, paragraphs 2, 3 and 4 are replaced by the

following:

(cid:145)2.
The competent authorities shall take all necessary
measures to ensure that the information concerning the
and in particular
veterinary medicinal product,
the
labelling and package leaflet,
is in conformity with that
approved in the summary of product characteristics
when
or
subsequently.

the marketing

authorisation

issued

is

The competent authorities shall make available to any
3.
interested person a copy of the marketing authorisation
together with the summary of product characteristics.

The

shall

authorities

the results of

draw up an
competent
4.
report and comments on the dossier as
assessment
regards
safety and
the pharmaceutical,
residue tests and the pre-clinical and clinical trials of the
veterinary medicinal product concerned. The assessment
shall be updated whenever new information
report
becomes
the
evaluation of the quality, safety or efficacy of the veterinary
medicinal product concerned.

available which is of

importance

for

At the request of any interested person, the competent
authorities shall make available the assessment report and
its reasons for the opinion after deleting any information
of commercially confidential nature.(cid:146)

16. Article 26 is amended as follows:

(a) Paragraph 1 is replaced by the following:

(cid:145)1.
The marketing authorisation may require the
holder to indicate on the 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
point
the first subparagraph of Article 12(3)
and in Articles 13 to 13d or from experience gained
during the use of
the veterinary medicinal product
once it has been marketed.(cid:146)

(j) of

(c) Paragraph 3 is replaced by the following:

circumstances,

In exceptional

(cid:145)3.
and following
consultation with the applicant, an authorisation may
be granted under specific conditions, which shall be
reviewed annually. Continuation of the initial author-
isation may be linked to the review of these conditions.

Such authorisations may be granted only for objective
and verifiable reasons.(cid:146)

17. Article 27 is amended as follows:

(a) Paragraphs 2 and 3 are replaced by the following:

The

competent

authority may

(cid:145)2.
the
applicant or the marketing authorisation holder to
to
provide sufficient quantities of
enable controls to be made on the identification of
the presence of residues of the veterinary medicinal
products in question.

the substances

require

from the competent authorities,

Upon request
the
marketing authorisation holder shall provide his/her
technical expertise to facilitate the implementation of
the
the analytical method for detecting residues of
national
veterinary medicinal
reference
Council
laboratory
Directive 96/23/EC (*).

products
designated

the
under

in

competent

authorities

3.
In order to allow the continuous evaluation of
the relation between the benefits and the risks, the
marketing authorisation holder shall also forthwith
forward to the
any new
information which might entail
the amendment of
the contents of the file or of the approved summary
of product characteristics.
In particular, he/she shall
forthwith inform the competent authorities of any
prohibition or restriction imposed by the competent
authorities of any country in which the veterinary
medicinal product is marketed or of any rejection of
an application for authorisation submitted in a third
country.

___________
(*) OJ L 125, 23.5.1996, p. 10.(cid:146)

(b) Paragraph 4 is deleted.

(c) Paragraph 5 is replaced by the following:

authorisation

The marketing

(cid:145)5.
shall
immediately inform the competent authorities, with a
view to authorisation, of any alteration which he/she
proposes to make to the particulars and documents
referred to in Articles 12 to 13d.(cid:146)

holder

18. Article 28 is replaced by the following:

(cid:145)Article 28

(b) Paragraph 2 is deleted.

1. Without prejudice to paragraphs 2 and 3, the auth-
orisation shall be valid for an unlimited period.

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Any authorisation that is not followed within two
2.
years of its issue by the actual marketing of the authorised
veterinary medicinal product in the authorising Member
State shall cease to be valid.

3. When an authorised veterinary medicinal product
previously placed on the market
in the authorising
Member State is no longer actually present on the
market
two
consecutive years, the authorisation shall cease to be valid.(cid:146)

in that Member State for a period of

19. Article 30 is replaced by the following:

(cid:145)Article 30

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

The authorisation shall also be withheld if examination of
the documents and particulars listed in Articles 12 and
13(1) establishes that:

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

application concerns

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

(c)

its qualitative or quantitative composition is not as
stated; or

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

(e)

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

(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.

Authorization shall also be withheld if
the application
documents submitted to the competent authorities do
not comply with Articles 12, 13(1) and 15.(cid:146)

20. The title of Chapter 4 is replaced by the following:

(cid:145)CHAPTER 4

Mutual
procedure(cid:146)

recognition procedure

and decentralised

21. Articles 31 to 35 are replaced by the following:

(cid:145)Article 31

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

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

The coordination group shall draw up its own rules
into force after a

3.
of procedure, which shall
favourable opinion of the Commission.

enter

Article 32

the applicant

1. With a view towards the grant of a marketing auth-
in two or
orisation for a veterinary medicinal product
submit an
more Member States,
shall
application referring to 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 shall
the Member States
concerned by the application.

include a list of

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

Where appropriate, the assessment report shall contain an
evaluation for the purposes of Article 13(4) or (5) or
Article 13a(3).

If

the veterinary medicinal product has already
2.
received authorisation by the time of application,
the
Member State(s) concerned 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 60 days of receipt of a valid
together with the
application. The assessment
approved summary of product characteristics,
labelling
and package leaflet shall be forwarded to the Member
State(s) concerned and the applicant.

report

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If the veterinary medicinal product has not received
3.
authorisation by the time of application, the applicant shall
request
the reference Member State to prepare a draft
assessment report and drafts of the summary 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.

4. Within 90 days of receipt of the documents referred
to in paragraphs 2 and 3, the Member States concerned
shall approve the assessment
the summary of
product characteristics,
the labelling and the package
leaflet and inform the reference Member State to this
effect.

report,

As soon as the applicant has been informed that the
4.
matter has been referred to the Agency, he/she shall
the
forthwith forward to the Committee a copy of
information and particulars
first
referred to in the
subparagraph of Article 32(1).

5.
In the case referred to in paragraph 3, 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
the authorisation granted shall be without
that case,
prejudice to the outcome of that procedure.

grant

The reference Member State shall ascertain the agreement,
close the procedure and inform the applicant accordingly.

Article 34

5.
Each Member State where an application 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 of acknowledgement of the agreement.

Article 33

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

the other Member States

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. Within the coordination group, all the Member States
referred to in Paragraph 1 shall use their best endeavours
to reach agreement on the action to be taken in respect of
the application. They shall provide the applicant with the
opportunity to make his/her point of view known orally or
in writing. If, within 60 days of the communication of the
reasons for disagreement to the coordination group the
Member
reference
reach an agreement,
Member State shall confirm the agreement, close the
procedure and inform the applicant accordingly. Article
31(5) shall apply.

States

the

3.
If within the period of 60 days the Member States fail
to reach an agreement, the Agency shall be immediately
informed with a view to application of the procedure laid
down in Article 36. 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.

a

for

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

the Commission, or

2. With a view to promoting the harmonisation of
veterinary medicinal products authorised for not
less
than ten years in the Community, and to strengthen the
efficiency of
the Member
the provisions of Article 11,
States shall send to the coordination group, no later than
[date], a list of veterinary medicinal products for which a
harmonised summary of product characteristics should be
prepared.

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

The medicinal products in this list are subject
to the
provisions in paragraph 1 following 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.

Article 35

the Commission or

The Member States or

1.
the
applicant or holder of the marketing authorisation may,
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 Article 36
before reaching a decision on a request for a marketing
authorisation or on the suspension or withdrawal of an
authorisation, 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.

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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.

2. Where the referral
to the Committee concerns a
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.(cid:146)

22. Article 36 is amended as follows:

(a) Paragraph 1 is replaced by the following:

(cid:145)1. When reference is made to the procedure laid
the Committee shall consider
down in this Article,
the matter concerned and shall
issue a reasoned
opinion within sixty days of the date on which the
matter was referred to it.

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

In an emergency, and on a proposal from its Chairman,
the Committee may agree to a shorter deadline.(cid:146)

(b) Paragraph 3 is replaced by the following:

(cid:145)3.
Before issuing its opinion, the Committee shall
provide the applicant or the marketing authorisation
holder with an opportunity to present written or oral
explanations.

The opinion of the Committee shall include the draft
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 in order to allow the applicant or the
marketing authorisation holder to prepare the expla-
nations.(cid:146)

(c) Paragraph 4 is amended as follows:

(cid:145)The Agency shall forthwith inform the applicant
or
the
the marketing authorisation holder of
opinion of the Committee if:(cid:146)

(ii) The second indent of

the first subparagraph is

replaced by the following:

(cid:145)(cid:151) the

of

product

summary

characteristics
proposed by the applicant or the marketing
authorisation holder
in accordance with
Article 14 should be amended.(cid:146)

(iii) The second subparagraph is

replaced by the

following:

the opinion,

(cid:145)Within 15 days of receipt of
the
applicant or the marketing authorisation holder
may notify the Agency in writing of his/her
In that case, he/she shall
intention to appeal.
forward the detailed grounds for appeal
to the
Agency within 60 days of receipt of the opinion.
the grounds for
Within 60 days of receipt of
its
appeal,
shall
opinion
second
accordance with
subparagraph of Article 53(1) of Regulation
(EEC) No 2309/93. The conclusions reached on
appeal shall be annexed to the assessment report
referred to in paragraph 5.(cid:146)

the Committee

reconsider

the

in

(d) Paragraph 5 is amended as follows:

(i) The first subparagraph is replaced by the following:

(cid:145)Within 30 days of its adoption, the Agency shall
forward the final opinion of the Committee to the
Member States,
to the Commission and the
applicant or the marketing authorisation holder
together with a report describing the assessment
of
the veterinary medicinal product and the
reasons for its conclusions.(cid:146)

(ii) In the second subparagraph, the following point (c)

is added:

(cid:145)(c) the drafts of the labelling and package leaflet(cid:146)

23. Article 37 is amended as follows:

(a) The second subparagraph is replaced by the following:

(cid:145)In the event of a draft decision which envisages the
granting of marketing authorisation,
the documents
referred to in the second subparagraph of Article
36(5), shall be annexed.(cid:146)

(b) The fourth subparagraph is replaced by the following:

(i) The

introductory

the
subparagraph is replaced by the following:

wording

of

first

(cid:145)The draft decision shall be forwarded to the Member
States and the applicant or marketing authorisation
holder.(cid:146)

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24. Article 38 is amended as follows:

28. In Article 44, the following paragraph 4 is added:

(a) Paragraph 1 is replaced by the following:

The Commission shall adopt a final decision in
(cid:145)1.
accordance with the procedure referred to in Article
89(3), where the draft decision is in conformity with
the Agency’s opinion.

The Commission shall adopt a final decision in
accordance with the procedure referred to in Article
89(4), where the draft decision is not in conformity
with the Agency’s opinion.(cid:146)

(b) In paragraph 2,

the second and third indents are

replaced by the following:

(cid:145)(cid:151) each Member State shall be allowed at least fifteen
days to forward written observations on the draft
decision of
the
Decision is urgent,
the President may set a
shorter deadline in the light of the urgency.

the Commission. However,

if

(cid:151) each Member State may require in writing that the
draft decision be discussed by the Standing
Committee in plenary session, giving its reasons
in detail.(cid:146)

(c) Paragraph 3 is replaced by the following:

A decision as referred to in paragraph 1 shall be
(cid:145)3.
addressed to all the Member States and communicated
to the marketing authorisation holder or the applicant
for information. The concerned Member States and the
reference Member State shall either grant or withdraw
marketing authorisation, or vary the terms of a
marketing authorisation as necessary to comply with
the decision within 30 days of its notification and shall
refer to it. They shall inform the Commission and the
Agency thereof.(cid:146)

25. In Article 39, the third subparagraph of paragraph 1 is

deleted.

26. In Article 42, paragraph 2 is replaced by the following:

(cid:145)2.
The Commission shall publish, no later than [date], a
report on experience gained on the basis of the procedures
in this chapter and shall propose any
provided for
amendments necessary to improve the procedures.(cid:146)

27. Article 43 is replaced by the following:

(cid:145)Article 43

The provisions of Article 33(3), (4) and (5) and Articles 34
to 38 shall not apply to the homeopathic veterinary
medicinal products referred to in Article 17.

The provisions of Articles 32 to 38 shall not apply to the
homeopathic veterinary medicinal products referred to in
Article 19(2).(cid:146)

(cid:145)4.
The Member State shall forward to the Agency a
copy of the manufacturing authorisations referred to in
information the
paragraph 1. On the basis of
Agency shall compile a database.(cid:146)

this

29. In Article 50, point (f) is replaced by the following:

(cid:145)(f) comply with the principles and the guidelines on good
manufacturing practice for medicinal products and use
as starting materials only active substances that have
been manufactured in accordance with the detailed
guidelines on good manufacturing practice for starting
materials.(cid:146)

30. The following Article 50a is inserted:

(cid:145)Article 50a

For the purposes of

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

Amendments which may be necessary to adapt the
this Article to scientific and technical
adopted in accordance with the

2.
provisions of
progress
procedure referred to in Article 89(2).(cid:146)

shall be

31. In Article 51, the following third and fourth paragraphs are

added:

(cid:145)The principles and guidelines on 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
the authorisation referred to in Article
and content of
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).(cid:146)

32. In Article 53, paragraph 1 is replaced by the following:

(cid:145)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.(cid:146)

33. In Article 54, paragraph 1 is replaced by the following:

date

A person engaging,

in a Member State,

in the
(cid:145)1.
activities of the person referred to in Article 52(1) on
the
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 in the Community.(cid:146)

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34. In Article 55, point (b) of paragraph 1 is replaced by the

(b) The following paragraph 5 is added:

following:

(cid:145)(b) in the case of veterinary medicinal products coming
from third countries, even if
the manufacture has
taken place in the Community, each production batch
imported has undergone in a Member State a full quali-
tative analysis, a quantitative analysis of at least all the
active substances, and all the other tests or controls
veterinary
the
necessary
medicinal
the
in
requirements of the marketing authorisation.(cid:146)

to
products

accordance with

quality

ensure

of

35. Article 58 is amended as follows:

(a) Paragraph 1 is amended as follows:

(cid:145)5.
In the case of medicinal products that have been
granted a marketing authorisation under Regulation
[(EEC) No 2309/93], Member States may permit or
require that
the outer packaging bear additional
information concerning distribution, possession, sale
or any necessary precautions, provided that
such
information is not in infringement of Community law
or the terms of the marketing authorisation, and is not
promotional.

This additional information shall appear in a box with
clearly from the
a blue border
information referred to in paragraph 1.(cid:146)

to separate

it

(i) The introductory wording is

replaced by the

following:

36. Article 59 is amended as follows:

the

the medicinal products
in the case of
(cid:145)Except
referred to in Article 17(1),
immediate
packaging and outer packaging of veterinary
shall be approved by the
medicinal products
the
shall
competent
following 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:(cid:146).

authorities. They

appear

bear

and

in

(ii) Points (a) and (b) are replaced by the following:

(cid:145)(a) the name of the medicinal product, comprising
the strength and/or pharmaceutical form, if the
medicinal product
in several
is
strengths and/or pharmaceutical forms;

available

(b) a statement of the active substances expressed
qualitatively and quantitatively per unit or
according to the form of administration for a
particular
the
volume or weight,
common names;(cid:146)

using

(a) The introductory wording of paragraph 1 is replaced

by the following:

(cid:145)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:(cid:146)

(b) Paragraphs 2 and 3 are replaced by the following:

(cid:145)2.
As regards small immediate packaging containing
a single dose, other than ampoules, on which it is
the particulars mentioned in
impossible
(2)
paragraph 1,
and (3), shall apply only to the outer package.

the requirements of Article 58(1),

to give

3.
The particulars mentioned in the third and sixth
indents of paragraph 1 shall appear on the outer
the
package and on the immediate packaging of
medicinal products in the language or languages of
the country in which they are placed on the market.(cid:146)

(iii) Point (e) is replaced by the following:

37. Article 60 is replaced by the following:

(cid:145)(e) name or

corporate name and permanent
address or registered place of business of the
marketing authorisation holder and, where
representative
appropriate,
designated by the marketing authorisation
holder;(cid:146).

local

the

of

(cid:145)Article 60

Where there is no outer package, all the particulars which
should feature on such a package pursuant to Articles 58
and 59 shall be shown on the immediate packaging.(cid:146)

(iv) Point (g) is replaced by the following:

38. Article 61 is amended as follows:

(cid:145)(g) the withdrawal period, expressed in hours or
days, for veterinary medicinal products to be
administered to food-producing species, for all
the species concerned and for
the various
foodstuffs concerned (meat and offal, eggs,
milk, honey),
including those for which the
withdrawal period is nil.(cid:146)

(v) Point (l) is replaced by the following:

(cid:145)(l)

the words (cid:147)For animal treatment only(cid:148) or, in
the case of the medicinal products referred to
in Article 67, the words (cid:147)For animal treatment
only (cid:151) to be supplied only on veterinary
prescription(cid:148).(cid:146)

(a) Paragraph 1 is replaced by the following:

The

leaflet

inclusion of a package

(cid:145)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
worded in terms
general public
language or
languages of
in which the
medicinal product is marketed.(cid:146)

and in the official

the Member

State

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(b) Paragraph 2 is amended as follows:

41. The title of Title VI is replaced by the following:

(i) The introductory wording is

replaced by the

(cid:145)TITLE VI

following:

(cid:145)The package leaflet shall be approved by the
competent authorities. It shall contain at least the
following information, which shall conform to the
particulars and documents provided pursuant
to
Articles 12 to 13d and the approved summary of
product characteristics:(cid:146)

(ii) Points (a) and (b) are replaced by the following:

(cid:145)(a) name or

corporate name

and permanent
address or registered place of business of the
marketing-authorisation holder
and, where
appropriate, of the manufacturer and the local
representative designated by the marketing
authorisation holder in the Member State;

(b) name of the veterinary medicinal product and
its active substances, expressed qualitatively and
quantitatively, using, wherever they exist, the
international non-proprietary names
recom-
mended by the World Health Organisation,
and stating the name authorised in each of
the medicinal
the Member States whenever
product has been authorised, under
the
procedure set out in Articles 31 to 43, under
different names in the various Member States
concerned.(cid:146)

(c) Paragraph 3 is deleted.

39. Article 62 is replaced by the following:

(cid:145)Article 62

Where the provisions of this Title are not observed and a
formal notice addressed to the person concerned has been
ineffectual, the competent authorities of the Member States
may suspend or withdraw marketing authorisation.(cid:146)

40. In Article 64, paragraph 2 is amended as follows:

(a) The introductory wording is replaced by the following:

(cid:145)In addition to the clear mention of the words (cid:147)homeo-
pathic veterinary medicinal product(cid:148), 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:(cid:146).

(b) The first indent is replaced by the following:

(cid:145)(cid:151) 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)
of Article 1;
the homeopathic veterinary
medicinal product is composed of more than one
stock, the scientific names of the stocks may be
replaced on the labelling by an invented name,(cid:146)

if

Possession, distribution and dispensing of veterinary
medicinal products(cid:146)

42. In Article 65, the following paragraph 3a is inserted:

The holder of a distribution authorisation shall have
(cid:145)3a.
an emergency plan guaranteeing the effective implemen-
tation of any recall operation ordered by the competent
authorities or undertaken in cooperation with the manu-
facturer of the medicinal product in question or the holder
of the marketing authorisation.(cid:146)

43. Article 66 is amended as follows:

(a) Paragraph 2 is amended as follows:

(i) the

introductory wording is

replaced by the

following:

(cid:145)Any person permitted under paragraph 1 to sell
veterinary medicinal products shall be required to
for veterinary medicinal
keep detailed records
that may
products
on
be
information being
following
the
prescription,
recorded in respect of each incoming or outgoing
transaction:(cid:146)

supplied

only

(ii) the third subparagraph is replaced by the following:

(cid:145)These records shall be available for inspection by
the competent authorities for a period of
five
years.(cid:146)

(b) Paragraphs 3 and 4 are deleted.

44. Article 67 is amended as follows:

(a) The first paragraph is amended as follows:

(i) the introductory wording is

replaced by the

following:

to stricter Community or
(cid:145)Without prejudice
national
rules relating to dispensing veterinary
medicinal products and serving to protect human
and animal health, a veterinary prescription shall
be required for dispensing to the public the
following veterinary medicinal products:(cid:146).

(ii) the following new point (a) is inserted:

(cid:145)(a) veterinary medicinal
producing animals(cid:146)

products

for

food-

(iii) the third indent of point (b) is deleted.

(iv) point (d) is replaced by the following:

(cid:145)(d) magistral or officinal

formulae intended for

animals.(cid:146)

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(b) The second paragraph is replaced by the following:

(cid:145)In addition, a prescription shall be required for new
veterinary medicinal products containing an active
substance which has been authorised for use in a
veterinary medicinal product for less than seven years.(cid:146)

45. The first paragraph of Article 69 is replaced by the

following.

(cid:145)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 a period of five years after
slaughter.(cid:146)

related to the use of veterinary
human beings
medicinal products, and to evaluate such information
scientifically.(cid:146)

(b) After the second paragraph, the following paragraph is

inserted:

the information
shall ensure that
(cid:145)Member States
collected within this system is forwarded to the other
Member States and the Agency in an appropriate
fashion. This information shall be recorded in the
database referred to in point
the second
(EEC)
51
paragraph
No 2309/93 and shall be permanently accessible to
all Member States.(cid:146)

of Regulation

of Article

(j) of

46. The introductory wording of Article 70 is replaced by the

following:

50. The introductory wording of

the second paragraph of

Article 74 is replaced by the following:

(cid:145)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
small quantities of
to animals
them and administer
daily
products
veterinary medicinal
requirements
veterinary
than
other
medicinal products which are not authorised for use in
the Member State in which the services are provided (here-
inafter: (cid:147)host Member State(cid:148)), providing that the following
conditions are satisfied:(cid:146)

not
immunological

exceeding

47. The following subparagraph is added to Article 71(1):

(cid:145)The Member State may also invoke the provisions of the
first subparagraph in order to withhold marketing author-
isation according to a decentralised procedure as provided
for in Articles 31 to 43.(cid:146)

48. In Article 72, paragraph 2 is replaced by the following:

States may

The Member

(cid:145)2.
specific
requirements on veterinary practitioners and other health
care professionals in respect of the reporting of suspected
serious or unexpected adverse reactions and human
adverse reactions.(cid:146)

impose

49. Article 73 is amended as follows:

(a) The first paragraph is replaced by the following:

decisions

suspected

regulatory

concerning

(cid:145)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,
the Member States shall administer a veterinary phar-
macovigilance system. This system shall be used to
surveillance of
collect
veterinary medicinal
particular
in animals and in
reference to adverse reactions

in the
products, with

information useful

reactions

adverse

(cid:145)That qualified person shall reside in the Community and
shall be responsible for the following:(cid:146)

51. Paragraphs 2 to 6 of Article 75 are replaced by the

following:

The marketing authorisation holder shall be required
(cid:145)2.
to record all
suspected serious adverse reactions and
human adverse reactions related to the use of veterinary
medicinal products which are brought to his/her attention,
and to report
competent
authority of
the Member State on whose territory the
incident occurred, and in no case later than 15 calendar
days following the receipt of the information.

them immediately to the

The marketing authorisation holder shall also be required
suspected serious adverse reactions and
to record all
human adverse reactions related to the use of veterinary
medicinal products of which he/she can reasonably be
expected to have knowledge,
them
immediately to the competent authorities of all Member
States in which the veterinary medicinal product is auth-
orised, and in no case later than 15 calendar days following
the receipt of the information.

and to report

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

3.
The marketing authorisation holder shall ensure that
any suspected serious and unexpected adverse reactions
and human adverse reactions occurring on the territory
of a third country are reported immediately in accordance
with the guidelines referred to in Article 77(1), so that they
are available to the Agency and the competent authorities
in the Member State(s) where the veterinary medicinal
product
than 15
is authorised, and in no case later
calendar days following the receipt of the information.

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By way of derogation from paragraphs 2 and 3, in
4.
the case of veterinary medicinal products covered by
Directive 87/22/EEC, or having benefited from the author-
isation procedures under Articles 31 and 32 or having
the procedures provided for under
been the subject of
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
to be accessible to the reference
such a way so as
Member State or a competent authority designated as
reference Member State. The reference Member State
shall assume responsibility for the analysis and follow up
any such adverse reactions.

5.
Unless other requirements have been laid down as a
condition for the grant of authorisation, records of all
adverse reactions shall be submitted to the competent
in the form of a periodic safety update
authorities
report, either immediately upon request or periodically
as follows: six monthly for the first two years after auth-
orisation, annually for
two years, and
three-yearly intervals. The periodic safety
thereafter at
update reports shall include a scientific evaluation of the
benefits and risks afforded by the veterinary medicinal
product.

the subsequent

Following the granting of a marketing authorisation,
6.
the
the holder of
amendment of
the periods referred to in paragraph 5,
using the procedure laid down by the Commission Regu-
lation (EC) No 541/95 (*), if need be.

such authorisation may request

___________
(*) OJ L 55, 11.3.1995, p. 7.(cid:146)

52. In Article 76, paragraph 1 is replaced by the following:

(cid:145)1.
The Agency, in collaboration with the Member States
set up a data-processing
and the Commission,
network to facilitate the exchange of pharmacovigilance
information regarding
veterinary medicinal products
marketed in the Community.(cid:146)

shall

53. In Article 77(1), the second subparagraph is replaced by

the following:

(cid:145)In accordance with those guidelines, the marketing auth-
orisation holder shall use internationally agreed veterinary
medical terminology for the transmission of reports on
adverse reactions.

The guidelines shall be published by the Commission and
shall
international harmonisation work
achieved in the field of pharmacovigilance.(cid:146)

take account of

54. Article 78 is amended as follows:

(a) Paragraph 2 is replaced by the following:

or

animal

If urgent action is necessary for protecting
(cid:145)2.
human
State
health,
concerned may suspend the marketing authorisation
of a veterinary medicinal product, provided that the
the Commission and the other Member
Agency,
States are informed on the following working day at
the latest.(cid:146)

the Member

(b) The following paragraph 3 is added:

(cid:145)3. When the Agency is informed in accordance
it shall give its opinion as
with paragraphs 1 or 2,
the
soon as possible, according to the urgency of
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), where the draft
decision is in conformity with the Agency’s opinion.

Final measures shall be adopted in accordance with the
procedure referred to in Article 89(4), where the draft
decision is not
in conformity with the Agency’s
opinion.(cid:146)

55. Article 80 is amended as follows:

(a) Paragraph 1 is replaced by the following:

The competent authority of the Member State
repeated
relating to

(cid:145)1.
concerned
inspection that
veterinary medicinal products are complied with.

by means
requirements

ensure
the legal

shall

of

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

In order to demonstrate that the data submitted with
applications for a certificate of compliance comply
with the monographs of the European Pharmacopoeia,
the body responsible for standardising the nomen-
clatures and quality norms within the meaning of the
Convention relating to the elaboration of a European
Pharmacopoeia (*)
the
Quality of Medicines) may ask the Commission or
the Agency to request such an inspection when the
starting material
the subject of a
in question is
European Pharmacopoeia monograph.

(European Directorate

for

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The competent authority of a Member State may carry
out an inspection of a starting material manufacturer at
the manufacturer’s own request.

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

(a)

trading establishments
inspect manufacturing or
and any laboratories entrusted by the holder of
the manufacturing authorization, 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 current provisions in the
Member States from 9 October 1981 which place
restrictions on these powers with regard to the
description of the manufacturing method;

(d) inspect

the premises 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 auth-
orisation holder.

___________
(*) OJ L 158, 25.6.1994, p. 19.(cid:146)

(b) Paragraph 3 is replaced by the following:

The

officials

representing

the
competent
(cid:145)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
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.(cid:146)

appropriate,

or, where

in Article

51

(c) The following paragraphs 4 to 7 are added:

(cid:145)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
the manufacturer
and
question is
as
guidelines
provided for by Community law.

complying with the principles
practice

good manufacturing

that

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,
appropriate.

if

6. Member States shall maintain, for the certificates
issued by their
of good manufacturing practice
competent
register of
authorities,
certificates of good manufacturing practice. This
register shall be managed at Community level by the
Agency.

a Community

7.
If an inspection as described in paragraph 1
results in the conclusion that the manufacturer does
not comply with good manufacturing practice as
provided for under Community law,
the competent
authority of the Member State shall also include this
information in the Community register referred to in
paragraph 6.(cid:146)

56. Article 82 is replaced by the following:

(cid:145)Article 82

is considered necessary for

1. Where it
reasons of
human or animal health, a Member State may require
the holder of a marketing authorisation for a live
for a veterinary immunological medicinal
vaccine, or
product
to preventive
Community measures,
to submit samples of batches of
the bulk product and/or veterinary medicinal product for
control by a national laboratory or a laboratory approved
by the Member State before the product is put into circu-
lation.

for a disease that

subject

is

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 inform all the other Member
States in which the veterinary medical product is auth-
orised as well as
the
Quality of Medicines of its intention to control the batch
in question.

the European Directorate for

In such cases,
Member
State
paragraph 1.

the competent authorities of another
the provisions of
shall not

apply

3.
After studying the control reports referred to in
Article 81(2), the laboratory responsible for the control
shall repeat all the tests carried out by the manufacturer
on the finished product on the samples provided,
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, providing that all the Member States concerned, and
if appropriate the European Directorate for the Quality of
Medicines, agree to this.

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For immunological veterinary medicinal products auth-
orised under [Regulation (EEC) No 2309/93], the list of
tests to be repeated by the control
laboratory may be
reduced only after agreement by the Agency.

The results of the tests shall be recognised by all the

4.
Member States concerned.

Unless the Commission is informed that a longer
the Member
is completed within

5.
period is necessary to conduct
States shall ensure that this control
60 days of receipt of the samples.

the tests,

concerned,

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

the European Directorate

for

(b) In paragraph 2, point (a) is replaced by the following:

(cid:145)(a) the particulars

as
supporting the
provided for in Articles 12 to 13d, have not been
amended in accordance with Article 27(1) and (5);(cid:146)

application,

58. In Article 84, point (a) of paragraph 1 is replaced by the

following:

(cid:145)(a) it

that

is clear

the benefit/risk assessment of

the
veterinary medicinal product is, under the authorised
conditions of use, unfavourable, particular regard being
had to the benefits for animal health and welfare and
to the safety and health benefits for the consumer,
when the application concerns a veterinary medicinal
product for zootechnical use.(cid:146)

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-(cid:224)-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.(cid:146)

57. Article 83 is amended as follows:

(a) Paragraph 1 is amended as follows:

(i) Point (a) is replaced by the following:

(cid:145)(a) the benefit/risk assessment of
is, under

the veterinary
medicinal product
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
authorisation concerns a veterinary medicinal
product for zootechnical use(cid:146).

59. In Article 89, paragraphs 2 and 3 are replaced by the

following:

(cid:145)2. Where reference is made to this paragraph, the regu-
latory procedure laid down in Article 5 of Decision
1999/468/EC shall apply,
in compliance with Article 7
and Article 8 thereof.

The period provided for
1999/468/EC shall be three months.

in Article 5(6) of Decision

3. Where reference is made to this paragraph,
the
advisory procedure laid down in Article 3 of Decision
1999/468/EC shall apply,
in compliance with Articles 7
and 8 thereof.

4. Where reference is made to this paragraph,
management procedure
Decision 1999/468/EC shall apply,
Articles 7 and 8 thereof.

the
laid down in Article 4 of
in compliance with

The period provided for
1999/468/EC shall be one month.

in Article 4(3) of Decision

(ii) The second subparagraph of point (e) is deleted.

The Standing Committee shall adopt its own rules of

5.
procedure.(cid:146)

(iii) Point (f) is replaced by the following:

(cid:145)(f) the

information given in the

application
to Articles 12 to 13d

documents pursuant
and 27 is incorrect;(cid:146)

(iv) Point (h) is deleted.

(v) The following second subparagraph is added:

a

Community

legislative
(cid:145)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.(cid:146)

60. Article 90 is replaced by the following:

(cid:145)Article 90

Member States shall take all necessary measures to ensure
that the competent authorities concerned communicate the
appropriate
information to each other, particularly
regarding compliance with the requirements adopted for
the authorisations referred to in Article 44, the certificates
referred to in Article 80(5) or for authorisation to place
products on the market.

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

C 75 E/254

EN

Official Journal of the European Communities

26.3.2002

conclusions

reached following an inspection as
The
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.

When the Commission is informed of such serious reasons,
it may, after consulting the Member States concerned, ask
the inspector of the competent supervisory authority to
carry out a new inspection; the inspector may be accom-
panied by two other inspectors from Member States that
are not parties to the disagreement.(cid:146)

61. Article 95 is replaced by the following:

(cid:145)Article 95

where appropriate, a safety factor reflecting the nature of
the substance being tested.(cid:146)

Article 2

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive by [date] at the latest and shall immediately inform
the Commission thereof.

When Member States adopt those provisions, they shall contain
a reference to this Directive or shall be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

Article 3

This Directive shall enter into force on the twentieth day
following that of its publication in the Official Journal of the
European Communities.

The Member States shall not permit foodstuffs for human
consumption to be taken from test animals unless an
appropriate withdrawal period has been established by
the competent authorities. The withdrawal period shall
including,
be at

least as laid down in Article 11(2),

Article 4

This Directive is addressed to the Member States.