EMA: Procedure for reporting of pharmacovigilance inspections requested by the CVMP
In this procedure a pharmacovigilance (PhV) inspection reports related to inspections requested by the Committee for Medicinal Products for Veterinary Use (CVMP) are detailed. The definitions, selection and duties of the involved parties (reporting inspector, lead inspector, etc.) are provided in the “Procedure for co-ordinating pharmacovigilance inspections requested by the CVMP” Ref. EMEA/INS/PhV-V/1 and the legal basis of such inspections is to be found in Article 57(1)(i) of Regulation (EC) No. 726/2004.