MHRA informes about Validity Date of UK issued GDP Certificates

Recommendation
9 September 2025
Basel, Switzerland
Specifics in the Distribution of Medicinal Products
A new post titled "GMP & GDP Certificates" was published on 16 May 2025 on the MHRA Inspectorate blog. In the post, the authority outlines its approach to the validity date of UK issued certificates confirming compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
Following the conclusion of the COVID-19 public health emergency declared by the WHO in May 2023, on-site inspections resumed, aiming to address the backlog of certificates that had exceeded their standard validity period.
For GMP certificates, the MHRA has introduced a new desk-based compliance assessment to provide updates for UK and third country manufacturing sites.
For GDP certificates, the following applies: "MHRA do not intend to automatically extend GDP certificates approaching, or beyond, 5 years of their issuing into 2025. GDP Certificates do not expire and can be considered valid, however, organisations should seek their own assurances of the GDP compliance of sites when undertaking their due diligence and consider the reliability of the certificate in their assessments."
More details are available in the MHRA blog post.
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