EU: Annexes 4 and 5 no Longer Included in the EU GMP Guide
Following the entry into application of Commission Implementing Regulations (EU) 2025/2091 and (EU) 2025/2154 on the principles and guidelines of Good Manufacturing Practice (GMP) for veterinary medicinal products and active substances for veterinary medicinal products on 16 July 2026, the European Commission removed Annexes 4 and 5 from the EU GMP Guide.
EudraLex Volume 4 now lists only the remaining annexes. Annexes 4 and 5 are no longer included. Unfortunately, no information on their removal is provided on the EudraLex Volume 4 website.
The implementing regulations on GMP for veterinary medicinal products can be found in a new section entitled “GMP requirements applicable to veterinary medicinal products”.
In our GMP knowledge portal, the GMP Compliance Adviser, the annex titles and numbering will be retained for reasons of traceability. The last valid versions of the annexes will continue to be available as PDF documents in the attachments.
Source:
EU: EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines
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