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Document 32023R0997
Amendment of list of variations not requiring assessment (veterinary medicines)
Commission Implementing Regulation (EU) 2023/997 of 23 May 2023 amending Implementing Regulation (EU) 2021/17 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)
- 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).
- EuroVoc thesaurus:
- drugs classification; market approval; drug surveillance; marketing standard; veterinary medicinal product
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- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- Standing Committee on veterinary medicinal products
- Planned adoption period:
- 01/04/2023 - 30/06/2023
- Check the status of this initiative on the Better Regulation Portal
-
- Documents:
- C/2023/3254 final (Implementing regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Documents:
- 32023R0997 (Implementing regulation)
- Date of publication:
- 24/05/2023