Regulations and guidelines
- Directive 2001/82/EC of the European Parlament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products
- Pharmaceutical Law
- Regulations on marketing authorisation of veterinary medicinal products
- Labelling Regulations of Veterinary Medicinal Products
- Regulations Regarding the Manufacture and Control of Veterinary Medicinal Products
- Regulation on the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists
- Regulation on pharmacovigilance
- Regulation on the establishing of residue limits of pharmacologically active substances in foodstuffs of animal origin
- Regulation on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin
Regulation on variations
- Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council
- Commission Implementing Regulation (EU) 2021/16 of 8 January 2021 laying down the necessary measures and practical arrangements for the Union database on veterinary medicinal products (Union product database)
- Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC
- COMMISSION REGULATION (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
- COMMISSION REGULATION (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products
Guidelines on variations