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Document 32025R2154
Rules on good manufacturing practice for active substances used as starting materials in veterinary medicinal products
Reglamento de Ejecución (UE) 2025/2154 de la Comisión, de 17 de octubre de 2025, por el que se establecen buenas prácticas de fabricación de los principios activos utilizados como materiales de partida en medicamentos veterinarios de conformidad con el Reglamento (UE) 2019/6 del Parlamento Europeo y del Consejo
- Legal basis:
- 32019R0006 - A93P2
- Initiative summary:
- This initiative will establish common rules for the manufacturing of active substances used as starting materials in veterinary medicinal products.
- EuroVoc thesaurus:
- seguridad de los alimentos; política sanitaria; farmacovigilancia; norma de comercialización; producto veterinario; inspección sanitaria; autorización de venta; norma de calidad; calidad del producto; modo de producción; especificación técnica; legislación veterinaria
-
- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- Standing Committee on veterinary medicinal products
- Planned adoption period:
- 01/10/2025 - 31/12/2025
- Check the status of this initiative on the Better Regulation Portal
-
- Documents:
- Ares(2025)511565 (Draft implementing regulation)Ares(2025)511565 (Draft implementing regulation)
- Legal basis:
- 32019R0006 - A93P2
- Leading service:
- Directorate-General for Health and Food Safety
- Committee:
- Standing Committee on veterinary medicinal products
- Check the status of this initiative on the Better Regulation Portal
-
- Consultation type:
- Stakeholder feedback
- Consultation duration (weeks):
- 4
-
- Documents:
- C/2025/3701 final (Implementing regulation)
- Leading service:
- Directorate-General for Health and Food Safety
-
- Documents:
- 32025R2154 (Implementing regulation)