Division 8

United Kingdom

In order to monitor the risk/benefit assessment, any new information not in the original application and all pharmacovigilance information shall be submitted to the competent authority. After marketing authorisation has been granted, any change to the content of the dossier shall be submitted to the competent authorities in accordance with Commission Regulations (EC) No 1084/2003^f1 or (EC) No 1085/2003^f2 for veterinary medicinal products authorised as defined in Article 1 of those Regulations, respectively.

Annotations

Footnotes

f1: OJ L 159, 27.6.2003, p. 1.
f2: OJ L 159, 27.6.2003, p. 24.

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.