MHRA: Alignment With EU on Extention of GMP and GDP Certificates
On 11 December, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) announced a validity extension of GMP and GDP certificates.
With the announcement of the return of international on-site inspections in November 2022, the authority announced an extension of the validity of GMP and GDP certificates until the end of 2023. As many of the inspections postponed during the COVID-19 pandemic have yet to be carried out, the MHRA has aligned with the EU regulations on the extension of validity. Their blog post states "The MHRA has decided (in consultation with our international partners) to continue the extension of the validity date until 2024 or until the completion of the next inspection, whichever comes first, unless otherwise stated on the certificate."
Inspections will continue to be prioritised based on risk so that manufacturers and wholesalers with the highest priority will be inspected first. In addition, inspections will be prioritised if the GMP or GDP certificate is already five years or older.
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