The GDP inspectorate has seen a growing number of false NHS and private prescriptions being used to obtain medicines from Marketing Authorisation Holders for the onward wholesale.
A founder member of the GDP Inspectorate when it was created in 2001, he is a Senior GDP Inspector responsible for inspecting the full range of UK distribution companies. He was a member of the PIC/S GDP working group, working on the training and aligning of GDP standards for PIC/S member countries. He was part of the EMA GDP drafting group preparing the GDP Guidelines and updates to the compilation of community procedures and involved in training the GMDP inspectors on the new guidelines.
Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.
In my last post I talked about the importance of ensuring medicines are only obtained from qualified suppliers. Equally important is the obligation distributors have in ensuring that only wholesalers or persons entitled to supply or administer medicines receive medicinal products. …
We have recently had a number of situations where companies have not understood the obligations placed on them by the Human Medicines Regulations 2012 Regulation 44 (2) and (3) and Good Distribution Practice in relation to qualification of suppliers. In …
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About the MHRA Inspectorate Blog
This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.