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Mark Birse

Former Deputy Director of the Inspection, Enforcement and Standards Division and Head of the MHRA Inspectorate & Process Licencing which employs over 75 Inspectors covering GCP, GDP, GLP, GMP & GPvP and the Process Licencing team

Group Manager of MHRA Devices Safety and Surveillance Group & Devices Software and Apps Group.

Joined the MHRA in 2002 as a GMP Inspector having previously worked in the pharmaceutical industry for over 10 years.

Do wholesale distributors require pharmacovigilance agreements?

Flip chart with the word compliance on, in the middle of a table

Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.

Imported Unlicensed Medicines and Centrally Authorised Medicines intended for other EU Member States

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice
Various medicines in blister strips

Previously, we have reminded importers of unlicensed medicines that Centrally Authorised medicines are the subject of Marketing Authorisations from the EMA, valid in all Member States and therefore cannot be notified for import into the UK as unlicensed medicines, unless …