Opinion of the Economic and Social Committee on the 'Proposal for a European Parliament and Council Directive on the Community code relating to veterinary medicinal products (codified version)'
Date: 2000-01-26
Institutions: European Economic and Social Committee
Subjects: multilingual dictionary, pharmaceutical legislation, public health, veterinary drug, veterinary medicinal product

15.3.2000

EN

Official Journal of the European Communities

C 75/11

Opinion of the Economic and Social Committee on the ‘Proposal for a European Parliament and
Council Directive on the Community code relating to veterinary medicinal products (codified
version)’

(2000/C 75/03)

On 4 October 1999, the Council decided to consult the Economic and Social Committee, under Article
95 of the Treaty establishing the European Community, on the above-mentioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for
preparing the Committee’s work on the subject, adopted its opinion on 17 December 1999. The
rapporteur was Mr Braghin.

At its 369th plenary session of 26 and 27 January 2000 (meeting of 26 January) the Economic and Social
Committee adopted the following opinion by 119 votes in favour and two abstentions.

1.

Introduction

2. General comments

The proposed directive aims to codify, and thus
1.1.
supersede, the various directives that have been issued to
harmonise the Member States’ legislation on veterinary med-
icinal products,
from Council Directives 81/851/EEC and
81/852/EEC of 28 September 1981 onwards.

1.1.1.
Codification is a means of simplifying and clarifying
Community legislation so as to ensure transparency and
correct interpretation, in accordance with the Commission
decision of 1 April 1987 and the Presidency Conclusions of
the Edinburgh European Council in December 1992.

1.2.
The new directive, which will codify the laws expressly
in a list of repealed
mentioned in Part A of Annex II
directives, must be adopted in full compliance with the normal
Community legislative procedures as laid down in Article 251
of the Treaty.

1.3.
This legislative codification proposal has been drawn
up on the basis of the texts of the acts published in the Official
Journal, to which no substantive changes may be made. The
Commission’s consolidated text brings together the above
mentioned directives and makes only such formal amendments
as are required.

1.4.
The Commission has taken account of the fact that
Council Regulation (EEC) No 2309/93 (1) has since laid down
Community procedures for the authorisation and supervision
of medicinal products for veterinary use and established the
European Agency for the Evaluation of Medicinal Products (2).

2.1.
The Committee welcomes this codification, as it pro-
vides an essential reference point for the relevant authorities
of the Member States. The proposed codification, reflecting a
long-felt need, was finally included in the Commission’s 1998
work programme and has now reached the proposal stage.
The Committee hopes that accelerated procedure, endorsed by
the interinstitutional agreement of 20 December 1994, will
enable the rapid adoption of the codified legislation, enabling
the directive to enter into force at least during the first half of
2000, if not on 1 January 2000 as stated in Article 99.

2.2.
The codification is complete inasmuch as it covers
Directive 90/677/EEC on immunological veterinary medicinal
products and Directive 92/74/EEC on homeopathic veterinary
medicinal products. The text is concluded by Annex I on
‘Requirements and analytical protocol, safety tests, pre-clinical
and clinical, for tests of veterinary medicinal products’.

2.3.
The codified text retains the terminology used in
the original directives and does not reflect more recent
developments, for instance the guidelines published by the
Committee for Veterinary Medicinal Products (4). As the more
recent versions of the repealed directives have applied more
up-to-date terminology, the result is that differing terms are
sometimes used in the various languages to express the same
concept. The Committee would therefore recommend that all
the languages use the up-to-date and now universally-used
terms. This would be a change in form rather than content.

1.5.
The codification proposal regarding veterinary med-
icinal products was drafted in parallel with the codification
proposal for the directives on medicinal products for human
use, on which the Committee has already given its opinion (3).

For the purposes of

2.3.1.
the smooth functioning of
the pharmacovigilance system, the Committee particularly
advocates applying the above suggestion in order to favour

(1) OJ L 214, 24.8.1993.
(2) Above-mentioned regulation and Directive 93/40/EC on which
the Committee has already issued an opinion — OJ C 269,
14.10.1991.

(3) OJ C 368, 20.12.1999, p. 3.

(4) Committee set up as part of the European Agency for the
Evaluation of Medicinal Products, ex Regulation (EEC) No
2309/93, with tasks specified by Directive 93/40/EEC, Article 1,
point 10.

C 75/12

EN

Official Journal of the European Communities

15.3.2000

the term ‘adverse reaction’ over ‘side-effect’ or ‘undesired
effect’, as the latter terms are no longer commonly used at
international level. Incorporating such developments in the
transposition of directives into national
laws is a way of
ensuring that the legislative framework is truly uniform.

2.3.2.
Furthermore, the Committee would like to see single
terms applied consistently and exclusively to single concepts,
such as for instance: ‘marketing authorisation’, ‘authorisation
holder’,
‘public
health’.

the product characteristics’,

‘summary of

2.3.3.
There are a number of discrepancies in the termin-
ology used in Annex I, owing to problems with the translation
from the original language. This sometimes makes it difficult
to understand how the Directive is to be applied. In view of
the technical nature of the points and their importance for the
correct preparation of the registration dossier, it would be
helpful to check the consistency of the translations and point
out and explain the resulting changes to the initial version in
specific notes or a special annex.

2.3.4.
The various language versions do not always match
up, possibly owing to imperfect translation from the original
document. The Committee suggests that the Commission
could make use of the present codification exercise to amend
any articles that were incorrectly translated from the reference
language in the first instance, while taking account of recent
terminological developments.

2.4.
The Committee, while aware of the importance of
this codification for the purposes of harmonising the rules
governing the sector and transposing the directive into national
legislation as rapidly as possible, recommends that the Com-
mission verify that technical terms are used in a consistent and
uniform way, possibly by setting up a team of experts
representing all the official EU languages. Particular attention
should be given to the following terms:

— adverse reactions / negative side effects

— veterinary medicinal product / medicinal product / pro-

prietary medicinal product

— holder of marketing authorisation / authorisation holder /

applicant

Brussels, 26 January 2000.

— public health / human health / animal health.

Chapter VII tackles pharmacovigilance, a field in which
2.5.
Community rules do not appear to be uniformly or fully
applied. In the Committee’s view, the content and practical
methodology should be clarified. Furthermore, given its
importance for protection of public health, pharmacovigilance
should be made a priority in the implementation of current
legislation.

2.6.
In the veterinary pharmaceuticals sector, there are still
diverging interpretations by national administrations, a certain
reluctance to trust scientific assessments from other Member
States and lengthy national administrative procedures — all
factors which have prevented full use of the advantages of the
new authorisation procedures (1). The Committee asks the
Commission, when planning new measures in the light of
experience gained, to ensure that risk/benefit analysis is the
point of reference in every scientific evaluation of the data
accompanying marketing authorisation requests.

The Committee hopes that new measures will be
2.7.
proposed for medicated foodstuffs (not covered as such in the
current directive), in order to guarantee the purity of the active
ingredients, quality standards, production procedures and
checks and that the balance of medicinal, veterinary and food
products meets specific qualitative criteria to protect human
health and animal welfare.

2.8.
The Committee hopes that when it conducts its overall
review of the registration system for veterinary and, in parallel,
human drugs in 2001,
the Commission, helped by the
major codification work currently under way, will focus on
simplifying the definition of specifications relating to quality,
safety and efficiency, applying the guidelines drawn up by
the Committee for Veterinary Medicinal Products (CVMP)
properly, making them an integral part of the new legislation
when necessary, and guaranteeing a free choice of authoris-
ation procedures (centralised system or mutual recognition) so
as to ensure adequate availability of products for the various
well- and lesser-known animal species, bearing in mind the
absolute priority which is to protect public health and develop
the concept of animal welfare.

(1) Communication from the Commission on the Commission
communication on the Community marketing authorisation
procedures for medicinal products — OJ C 229, 22.7.1998.

The President

of the Economic and Social Committee

Beatrice RANGONI MACHIAVELLI