Update to “Q&A – Generic Applications” Guidance (Revision 8)

Following adjustments made in October 2025 due to the new Variations Regulation — Commission Delegated Regulation (EU) 2024/1701 amending Regulation (EC) No 1234/2008 — the guidance document “Q&A – Generic Applications” has been updated again in January 2026.

In Revision 8, updates focus solely on Question 8.b, which addresses whether generic medicines can apply for fewer modes of administration than the originator product. One key change involves removing the word “oral” from the wording of the question, broadening its scope to cover administration routes more generally.

The revision also introduces additional requirements and clarifications specifically related to enteral administration for generic medicines. Alongside these technical updates, several minor editorial and formatting adjustments have been made to improve clarity.

The updated Revision 8 of the Q&A – Generic Applications document is available on the website of the CMDh (Co‑ordination Group for Mutual Recognition and Decentralised Procedures – Human) in two formats: one with tracked changes and another as a clean version without change tracking.

04-03-2026