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Document C(2025)3701
Rules on good manufacturing practice for active substances used as starting materials in veterinary medicinal products
RÈGLEMENT D’EXÉCUTION (UE) …/... DE LA COMMISSION établissant les bonnes pratiques de fabrication des substances actives utilisées comme matières premières dans les médicaments vétérinaires conformément au règlement (UE) 2019/6 du Parlement européen et du Conseil
- 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:
- politique de la santé; sécurité des aliments; produit vétérinaire; norme de qualité; législation vétérinaire; norme de commercialisation; qualité du produit; spécification technique; autorisation de vente; inspection sanitaire; surveillance des médicaments; mode de production
-
- 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)