WRITTEN QUESTION E-0021/02 by Graham Watson (ELDR) to the Commission. Veterinary health products.
Date: 2002-01-21
Institutions: European Parliament, Provisional data
Subjects: United Kingdom, approximation of laws, consumer protection, drug surveillance, organisation of health care, pharmaceutical legislation, veterinary drug, veterinary legislation

29.8.2002

EN

Official Journal of the European Communities

C 205 E/59

(2002/C 205 E/062)

WRITTEN QUESTION E-0021/02

by Graham Watson (ELDR) to the Commission

(21 January 2002)

Subject: Veterinary health products

The proposed change to Article 67, EU Directive 2001/82/EC (1) on veterinary health products would make
all animal medicines for farm livestock and horses available only under a veterinary prescription.

Has the Commission presented any evidence which shows that the present UK regulatory system regarding
distribution of medicines is ineffective?

Similarly, can the Commission show any evidence of benefits that would be gained by amending the
existing legislation?

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

Answer given by Mr Liikanen on behalf of the Commission

(21 February 2002)

The Commission would like to refer the Honourable Member to its reply to written questions E-2913/01
by Mr Bowe (1) and E-3323/01 by Mr Wyn (2).

The Commission would like to reiterate that
its proposals to amend the veterinary pharmaceutical
legislation address among others the provisions relating to prescription, but not to distribution. The
question of whether a given national distribution system is effective or not, has not been considered in this
context. However, the Commission is evaluating whether the current British system, which may provide
for a significant number of veterinary medicines to be available without prescription, is in conformity with
the existing Community legislation, and particularly Article 67 of Directive 2001/82/EC of the Parliament
and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal
products.

Replacing,
in the above-mentioned article, the current prescription requirement for ‘those products in
respect of which special precautions must be taken by the veterinarian in order to avoid any unnecessary
risk to … the consumer of foodstuffs obtained from treated animals’ by a prescription requirement for
‘veterinary medicinal products for food producing animals’ aims at a full harmonisation of the legal status
of these veterinary medicinal products in the Member States.
In addition, this would complete the
Community legal framework and provide for a comprehensive traceability and record-keeping framework
for prescription, distribution and final use of veterinary medicines for food producing animals. This is in
line with the existing provisions of Council Directive 96/23/EC of 29 April 1996 on measures to monitor
certain subtances 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 (3), and particularly its Article 10,
and also in keeping with the different responsibilities in case of inappropriate use of drugs. The main
objective of this amendment is to ensure consumer protection in association with maximum benefit for
animal health and welfare.

(1) OJ C 93 E, 18.4.2002, p. 209.
(2) OJ C 115 E, 16.5.2002, p. 253.
(3) OJ L 125, 23.5.1996.