Guidance on the application of the revised variations framework
Following the revision of the Variation Regulation applicable since 1 January 2025, the European Commission (EC) has now adopted and published the final version of the EC guidelines on the details of the various categories of variations and operation of the procedures. The guidelines apply from 15 January 2026. In the coming months, the CMDh will publish updates to several guidance documents and templates related to variations to bring them in line with the new EC guidelines. Further guidance on the application of the revised variations framework can be found on the CMDh webpage. EC guidelines...
Lasīt vairāk Zāļu valsts aģentūras vietnē
