91997E3789

WRITTEN QUESTION E-3789/97 by David Hallam (PSE) to the Commission (26 November 1997)

Subject: Barrier to trade in Denmark: Veterinary pharmaceutical product, Super-Ov

Is the Commission aware of the obstruction provided by the Danish authorities preventing Global Genetics of Unit One Moreton Farm, Eye, Leominster HR6 ODP from marketing the veterinary pharmaceutical product Super-Ov, for which the marketing authorization was applied for on 4 May 1994.

What steps is the Commission taking to ensure that the Danish authorities comply with Directive 81/851/EEC ((OJ L 317, 6.11.1981, p. 1. )) and other single market compliance legislation?

When does the Commission envisage this issue being resolved to the satisfaction of Global Genetics and the British authorities who have submitted a formal complaint on behalf of Global Genetics? (Complaint number 96/4399).

Answer given by Mr Bangemann on behalf of the Commission (15 December 1997)

The Honourable Member refers to a complaint lodged with the Commission concerning an alleged infringement of Community pharmaceutical legislation by Denmark. The complainant claimed that he had filed a complete application with the Danish authorities concerning the placing on the market of the veterinary medicinal product 'Super-OV' in May 1994 and that he had been waiting for a decision from the Danish authorities ever since.

Following a request for information on this issue, the Danish authorities confirmed that they still needed additional information, in line with Community legislation, in order to be able to grant a marketing authorisation for the product in Denmark. On request of the Commission, the Danish authorities, on 25 October 1996, sent a letter to the complainant in which they listed the information and documentation which he still had to provide. The Commission advised the complainant several times to act accordingly and to provide the Danish authorities with the information and documentation legitimately required.

As the complainant did not follow this advice, the Commission decided, on 15 October 1997, to close this complaint case.