Pharmacovigilance inspection procedures: human

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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.

Send all queries regarding this content to gcp@ema.europa.eu.

Union procedures

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Other documents

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Document(s) Language Status First published Last updated Effective Date
Pharmacovigilance inspection policy for centralised procedures - medicinal products for human use (English only)   2009-11-27 2013-07-24  

Superseded - inspection procedures

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Document(s) Language Status First published Last updated Effective Date
Procedure for the preparation of a risk-based programme for routine pharmacovigilance inspections of MAHs connected with human Centrally Authorized Products (CAPs) (English only) adopted 2009-04-20 2014-06-20  
Procedure for coordinating pharmacovigilance inspections requested by the CHMP (English only) adopted 2007-11-12 2014-06-20  
Procedure for conducting pharmacovigilance inspections requested by the CHMP (English only) adopted 2007-11-12 2014-06-20  
Procedure for reporting of pharmacovigilance inspections requested by the CHMP (English only) adopted 2007-11-12 2014-06-20