25.1.2008   

EN

Official Journal of the European Union

L 22/8

(1)

All pharmacologically active substances used in the Community in veterinary medicinal products intended for food-producing animals should be evaluated in accordance with Regulation (EEC) No 2377/90.

(2)

The substances dinoprost tromethamine and dinoprost are included in Annex II to Regulation (EEC) No 2377/90 in the category of organic compounds, for all mammalian species. A request has been made to the Committee for Medicinal Products for Veterinary Use (CVMP) to examine whether the assessments performed and conclusions reached for dinoprost tromethamine and dinoprost also apply to dinoprostone. The CVMP considered that given the structural similarity of dinoprostone and dinoprost, and the fact that dinoprostone is rapidly metabolised to dinoprost, the safety assessments performed for dinoprost tromethamine and dinoprost also apply to dinoprostone. Consequently, the CVMP concluded that there is no need to establish maximum residue limits for this substance. Following the conclusions of the CVMP, it is considered appropriate to include a new entry in Annex II, in the category of organic compounds, for dinoprostone, for all mammalian species.

(3)

Regulation (EEC) No 2377/90 should therefore be amended accordingly.

(4)

An adequate period should be allowed before the applicability of this Regulation in order to enable Member States to make any adjustment which may be necessary in the light of this Regulation to the authorisations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (2).

(5)

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