WRITTEN QUESTION E-2620/99 by Robert Sturdy (PPE-DE) to the Commission. Approval system for veterinary medicines.
Date: 2000-01-12
Institutions: European Parliament, Provisional data
Subjects: legal basis, marketing, veterinary drug

3.10.2000

EN

Official Journal of the European Communities

C 280 E/85

(2000/C 280 E/087)

WRITTEN QUESTION E-2620/99

by Robert Sturdy (PPE-DE) to the Commission

(12 January 2000)

Subject: Approval system for veterinary medicines

The Commission is certainly aware that there is a current lack of availability of veterinary medicines across
the EU.

As I understand it, there are two principal reasons for this:

1.

2.

the inability of the Committee for Veterinary Medicinal Products (CVMP) to establish maximum
residue limits for a number of active substances used in medicinal products, and

the failure of the sponsoring companies to provide sufficient safety and residue data to enable the
Committee to complete its work.

Without the availability of such veterinary medicines, farmers are faced with two choices B either that they
accept the unnecessary and considerable economic burden imposed on them by their ailing livestock,
something they should not have to and/or may not be able to do, or that they give their livestock untested
remedies which would have an incalculable effect on the health and safety of both animals and humans.

An efficient veterinary medicines approval system should determine the safety of new medicines.
Furthermore, the same level of transparency in residue monitoring programmes must be applied across
all Member States. Currently the UK is the only Member State to publish the results of its approval process.

What is the Commission doing to ensure that the veterinary medicines approval system currently in place
is efficient?

Answer given by Mr Liikanen on behalf of the Commission

(10 February 2000)

The Commission is certainly aware of the problem of availability of veterinary medicinal products on the
market. The current evaluation system for approval and surveillance of veterinary medicinal products is
based on quality, efficacy and safety criteria under an umbrella of the protection of human and animal
health and the environment. After the grant of a marketing authorisation, veterinary medicines must
continue to meet safety and efficacy requirements and offer an acceptable balance between their benefits
and risks during the life of the products. To fulfil these objectives, the implementation of several legal
provisions and Commission initiatives contribute to an assurance that the veterinary medicines approval
system is efficient.

The establishment of a surveillance system for veterinary medicinal products on the market, according to
the framework foreseen in Chapter VIa (Pharmacovigilance) of Council Directive 81/851/EEC of 28 Sep-
tember 1981, on the approximation of the laws of the Member States relating to veterinary medicinal
products (1), provides for the collection and evaluation of pharmacovigilance data that can be traced to the
use of veterinary medicinal products thereby contributing to the appropriate use of products to satisfy
clinical needs.

A surveillance system establishing measures to monitor certain substances and residues thereof in live
animals and animal products in accordance with Council Directive 96/23/EC of 29 April 1996 on
measures to monitor certain substances and residues thereof in live animals and animal products and
repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (2), con-
tributes to ensuring the safe use of medicines in food producing animals.

Mechanisms ensure that animals may be treated with off label use medicines under certain conditions in
order to protect the animal and the consumer. Article 4 of Council Directive 81/851/EEC already provides
that where no authorised product for a condition exists the Member States may exceptionally, in particular
to avoid causing unacceptable suffering to the animal concerned, permit the administration of another

C 280 E/86

Official Journal of the European Communities

EN

3.10.2000

product by a vet under specific conditions. For food-producing animals an extended withdrawal time has
to be observed to ensure that food obtained from treated animals does not contain residues harmful to the
consumer. In the particular case of horses, an appropriate mechanism provides for the separation of
equidae intended for slaughter for human consumption which are subject to the medication rules for food
producing animals, and those equidae which are specifically marked either to definitively exclude them
from the food chain or to allow their slaughter under the condition that any such treatment is recorded in
the special section of a (cid:145)horse passport(cid:146), in accordance with recently adopted Community legislation and
that a general withdrawal period of six months is observed.

In order to address the problems of availability of veterinary medicines, the Commission is currently
working on a proposal to amend Council Regulation 2377/90 of 26 June 1990 laying down a Community
procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs
of animal origin (3) and Council Directive 81/851/EEC. This will be sent at the earliest possible moment to
the Council and the Parliament.

Finally, in more general terms, as regards the evaluation of the veterinary medicines approval system, the
Commission has recently contracted out an audit of the entire system of authorisation and supervision of
this
medicinal products in the Community to an independent consultant. Based on the results of
evaluation, the Commission will submit a proposal for a new system to the Council and Parliament in
2001.

(1) OJ L 317, 6.11.1981, as amended by Council Directives 90/676/EEC, OJ L 373, 31.12.1990, and 93/40/EEC,

OJ L 214, 24.8.1993.
(2) OJ L 125, 23.5.1996.
(3) OJ L 224, 18.8.1990.

(2000/C 280 E/088)

WRITTEN QUESTION E-2621/99

by Isidoro SÆnchez Garc(cid:237)a (ELDR) to the Commission

(12 January 2000)

Subject: Bringing the rules of the Spanish Swimming Federation allowing no more than two non-Spanish

players to play in the national water polo league into line with Community law

Article 20 of the rules of the Royal Spanish Swimming Federation stipulates that (cid:145)Clubs taking part in open
competitions may obtain licences for two players whose nationality is other than Spanish (cid:133)(cid:146).

Bearing in mind that the league is non-professional, does this restriction comply with Community law
when applied to players who are nationals of the Member States?

Does this restriction comply with Community law if the players in question are nationals of the Member
States employed under labour contracts?

Answer given by Mrs Diamantopoulou on behalf of the Commission

(28 February 2000)

The Court of justice has, with the Bosman judgement (1), confirmed that Community law provisions on
free movement are applicable to professional sports and, in particular, that Article 39 (ex Article 48) of the
EC Treaty on freedom of movement of workers applies to the rules of sporting associations. Limitation of
the number of players having the nationality of other Member States who may be fielded in a match is
therefore contrary to Community law.

Amateurs, that is to say people who are not practising sport as an economic activity, are not covered by
that judgement.