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Amendment of list of variations not requiring assessment (veterinary medicines)
Provedbena uredba Komisije (EU) 2023/997 оd 23. svibnja 2023. o izmjeni Provedbene uredbe Komisije (EU) 2021/17 o utvrđivanju popisa izmjena koje ne zahtijevaju ocjenjivanje u skladu s Uredbom (EU) 2019/6 Europskog parlamenta i Vijeća (Tekst značajan za EGP)
Initiative summary:
This initiative will update the list of changes to the terms of a marketing authorisation of a veterinary medicine (variations), which do not require the assessment of a Competent Authority of a Member State, including the conditions and documents to be provided by the marketing authorisation holder (a company that owns the medicine).