GOV.UK
GMDP Symposium 2017 - GDP Days
The focus of the 2017 GDP Symposium was risky business! This year the complimentary themes of Risk Management and Transportation ran throughout the various sessions at the event.
Good distribution practice
Looking for a New Challenge in 2018?
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.
GDP Inspection Deficiency Data for 2016
To assist wholesalers to understand areas where significant GDP failures have been observed, the GDP Inspectorate has published the inspection deficiency data for 2016.
EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase
Today marks the start of the operational phase of the EU-FDA mutual recognition agreement
International regulators inspecting in the UK
The MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries.
PIC/S - Press release and news of TFDA hosted meetings and seminar, September 2017
From 11 to 15 September 2017 I attended the PIC/S Committee meeting, Executive Bureau meeting, and Annual Seminar hosted by the Taiwan Food and Drug Administration (TFDA)
Missed our last few posts?
A bite sized summary of our recent posting to the MHRA Inspectorate blog
Do wholesale distributors require pharmacovigilance agreements?
Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.
Use of Freezers
This post describes the main issues seen when freezers are used by pharmaceutical wholesalers and provides an MHRA GDP inspectors’ view on possible ways to address them.
Imported Unlicensed Medicines and Centrally Authorised Medicines intended for other EU Member States
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 …