Division 9

United Kingdom

The environmental risk assessment connected with the release of veterinary medicinal products containing or consisting of Genetically Modified Organisms (GMOs) within the meaning of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council^f1 shall be provided in the dossier. The information shall be presented in accordance with the provisions of Directive 2001/18/EC and Regulation (EC) No 726/2004 of the European Parliament and of the Council^f2, taking into account guidance documents published by the Commission.

Annotations

Footnotes

f1: OJ L 106, 17.4.2001, p. 1.
f2: OJ L 136, 30.4.2004, p. 1.

Notes on Annex II

Footnotes

f1: This Annex will be amended by the Commission in accordance with Articles 146 and 153. All references to Articles or to ‘this Directive’ in this Annex, unless otherwise specified, are to be understood as references to Directive 2001/82/EC.