MHRA informes about Validity Date of UK issued GDP Certificates
Recommendation

8 September 2026
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.
Related GMP News
14.07.2026USP Proposes to Revise the Definition of Controlled Room Temperature in Chapter <659>
14.07.2026GDP in Hong Kong: Authority Provides Additional Information
14.07.2026GDP Inspection Responses: MHRA’s Expectations for AI Use in GxP Replies
14.07.2026FDA Warning Letter to Amazon: Unapproved New Drugs Sold via Online Marketplace
18.06.2026GDPA Participated as an Observer in the EMA GMDP-IWG Interested Parties Meeting


