![]() ![]() Responsibilities It is the responsibility of the Head of Veterinary Medicines to ensure that this SOP is adhered to. Scope This standard operating procedure (SOP) applies to CVMP members and alternates, CVMP Pharmacovigilance Working Party members and the European Medicines Agency (EMA) staff of the veterinary medicines sector in the veterinary medicines and product data management unit. Purpose To enable a transparent procedure for the management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products following the granting of a central marketing authorisation by the European Commission and to ensure timely submission and assessment of the PSURs as well as the follow-up of the conclusions and recommendations of the Committee for Medicinal Products for Veterinary Use (CVMP). Standard operating procedure Title: Management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products Status: PUBLIC Lead author Name: Raquel Gopal Signature: on file Date: 28-MAR-12 Approver Name: Kornelia Grein Signature: on file Date: 28-MAR-12 Document no.: SOP/V/4023 Effective date: 30-MAR-12 Review date: 30-MAR-15 Supersedes: SOP/V/4023 (03-JUN-09) TrackWise record no.: 3502 1. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |