Division 8 F1

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.