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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Union procedures

Union guidance on record keeping and archiving of documents obtained or resulting from pharmacovigilance inspections

Reference Number: EMA/INS/PhV/773932/2022 – Rev 01

Union procedure on the follow-up of pharmacovigilance inspections

Adopted Reference Number: EMA/INS/PhV/327777/2018 Legal effective date: 01/05/2020

Union procedure on the coordination of EU pharmacovigilance inspections

Adopted Reference Number: EMA/INS/PhV/192234/2014 Legal effective date: 01/06/2014

Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections

Adopted Reference Number: EMA/INS/PhV/192230/2014 Legal effective date: 01/06/2014

Appendix 1 - Pharmacovigilance inspection report template (Human)

Appendix 2 - PhV inspection overview template

Appendix 3 - PhV inspection outcome sharing template

Template for pharmacovigilance assessment information sharing

Template for pharmacovigilance inspection information sharing

European Union list of planned and conducted pharmacovigilance inspections

Summary:

European Union list of planned and conducted pharmacovigilance inspections

Union procedure on sharing of pharmacovigilance inspection information

Adopted Reference Number: EMA/INS/PhV/192233/2014 Legal effective date: 01/06/2014

Union recommendations on the training and experience of inspectors performing pharmacovigilance inspections

Adopted Reference Number: EMA/INS/PhV/192237/2014 Legal effective date: 01/06/2014