Commission Regulation (EC) No 649/98 of 23 March 1998 amending the Annex to Council Regulation (EEC) No 2309/93 (Text with EEA relevance)
Date: 1998-03-23
Institutions: European Commission
Subjects: European Medicines Agency, marketing standard, medicinal product, pharmaceutical legislation, veterinary drug

24. 3. 98

EN

Official Journal of the European Communities

L 88/7

COMMISSION REGULATION (EC) No 649/98

of 23 March 1998

amending the Annex to Council Regulation (EEC) No 2309/93

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to 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
Agency for the Evaluation of Medicinal Products (1), and
in particular Article 3(5) thereof,

Whereas for the purposes of animal health protection and
given the specific nature of
in veterinary
medicinal products, encouragement should be given to
pharmaceutical companies so that new and/or innovative
medicinal products in the veterinary field are placed on
the market as soon as possible;

the market

Whereas pharmaceutical companies are bound by essen-
tial requirements for the development of medicinal prod-
ucts relating to, inter alia, clinical and toxicological
vary
studies; whereas
according to whether the medicinal product is intended
for domestic animals, animals producing food for human
consumption or both categories of animal;

requirements

essential

these

Whereas new and innovative veterinary medicinal prod-
ucts should be the subject of coherent and effective super-
vision by way of pharmacovigilance; whereas it is there-
fore preferable to entrust the supervision of a particular
medicinal product to a single national or Community
authority, regardless of its indications and target species;

possibility, for a given new and/or innovative medicinal
product, of a single type of national or Community
authorisation whatever the target species for that product;

Whereas therefore it must be possible for the European
Agency for the Evaluation of Medicinal Products to carry
out an evaluation, at the request of a company, of any
veterinary medicinal product containing a new active
substance which, on the date of entry into force of this
Regulation, was not authorised by any Member State for
use in animals;

Whereas the measures provided for in this Regulation are
in accordance with the opinion of
the Standing
Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

Article 1

In the Annex to Regulation (EEC) No 2309/93, Part B,
the last indent shall be replaced by the following text:

‘Veterinary medicinal products containing a new active
substance which, on the date of entry into force of this
Regulation, was not authorised by any Member State for
use in animals'.

Article 2

Whereas it is also necessary to improve the transparency
of and ease of access to the market in veterinary medi-
cinal products by offering pharmaceutical companies the

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

This Regulation shall be binding in its entirety and directly applicable in all Member
States.

Done at Brussels, 23 March 1998.

For the Commission

Martin BANGEMANN

Member of the Commission

(1) OJ L 214, 24. 8. 1993, p. 1.