Pharmacovigilance inspection procedures: human

European Union pharmacovigilance inspectors have developed Union procedures and guidance on pharmacovigilance inspections of marketing-authorisation holders of human and veterinary medicines.

The Union procedures support harmonisation for the mutual recognition of pharmacovigilance inspections and to facilitate administrative collaboration and the exchange of inspection-related information. They apply to inspections conducted following adoption by the Committee for Medicinal Products for Human Use (CHMP) or under the national inspection programmes of concerned Member States.

National competent authorities of all Member States are expected to take account of the Union procedures and use them as the basis for standard operating procedures on the quality systems established within the inspectorates themselves.

The European Medicines Agency is responsible for maintaining and publishing the Union procedures.

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