As of 16 July 2026, a new EU GMP framework (Commission Implementing Regulations (EU) 2025/2091 and 2025/2154) applies to veterinary medicinal products and the active substances used in their manufacture. The new regulations transfer existing GMP expectations from Volume 4 of EudraLex into sector-specific, directly applicable and legally binding EU legislation.

‍

What has changed?

Regulation (EU) 2025/2091 consolidates the responsibilities of the Marketing Authorisation Holder, reinforcing coordination with manufacturers regarding product specifications, manufacturing instructions, regulatory changes and Product Quality Reviews. It also provides a specific legal basis for the use of ionising radiation and gives direct legal force to existing requirements such as the ongoing stability program.

‍

In parallel, Regulation (EU) 2025/2154 similarly reorganises the requirements for active substances contained in Part II of EudraLex. The European Commission’s correspondence tables help companies identify which requirements are new and which have been transferred or reorganised.

‍

Why does it matter?

For companies, the transition requires more than updating regulatory references. Existing procedures, quality agreements and responsibilities should be reviewed to confirm alignment with a new framework with particular attention given to communication between Marketing Authorisation Holders, manufacturers and outsourced partners, as well as to stability programs, data integrity and supplier oversight.

‍

While some organisations may require only limited documentary updates, others may need broader changes to quality systems, contracts and internal processes. The transition therefore represents both a compliance challenge and an opportunity to strengthen governance, cooperation across the supply chain and control over product quality.

‍