The UK regulator for medicines, medical devices and blood components for transfusion in the UK, The Medicines and Healthcare products Regulatory Agency (MHRA) have further extended the validity period of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Certificates.
The MHRA has advised that, following consultation with their international partners, a decision was made to automatically extend the period of validity of GMP and GDP certificates issued by the MHRA until the end of 2024 or until the conclusion of the next inspection, whichever comes first, except where clarifying remarks in the document state otherwise. On-site inspections are being conducted and scheduling of these inspections may be independent of the extended validity period. The MHRA has stated that “In the meantime, we reserve the right to perform risk-based supervision of sites by either on-site or remote inspections and, based on the outcome, may continue to issue, withdraw or restrict GMP and GDP certificates as appropriate.”
An explanatory footer has been introduced by The MHRA in the MHRA GMDP database. Manufacturers, importers and distributors must ensure that they continue to comply with GMP/GDP and all other legal obligations.
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