2026/2685(DEA)SANT

Examination of variations to the terms of marketing authorisations for medicinal products for human use

Commission Delegated Regulation correcting certain language versions of Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use

Last activity: 29 Apr 2026

1 entry · record as of 12 Oct 2026

Where it stands

Latest: Referred to committee, 29 Apr 2026.

29 Apr 2026
- Referred to committee

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Commission Delegated Regulation correcting certain language versions of Regulation (EC) No 1234/2008, which governs examination of variations to the terms of marketing authorizations for human medicinal products. The correction targets linguistic discrepancies in the existing variation framework. It affects marketing authorization holders and regulators handling variation applications.

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Sources: EP Legislative Observatory. Record as of 12 Oct 2026. Something wrong on this page? Report an error.

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