New EU legislation
Recently, the new European legislation relating to veterinary medicines and medicated feed has been published.
It concerns the following regulations:
- Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC.
- Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use.
- 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.
The consequences for other EU legislation are summarized in the table below.
The legislation will enter into force in the EU on 28 January 2019. Subsequently, there will be a transitional period of 3 years, which means that this legislation will become applicable on 28 January 2022.
| New legislation | Subject | Amending | Repealing |
| Regulation (EU) 2019/4 | Medicated feed | Regulation (EC) No 183/2005 | Directive 90/167/EEC |
| Regulation (EU) 2019/5 | Authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency | Regulation (EC) No 726/2004
Regulation (EC) No 1901/2006 Directive 2001/83/EC |
N.A. |
| Regulation (EU) 2019/6 | Veterinary medicinal products | N.A. | Directive 2001/82/EC |
The original texts in different languages can be found on EUR-Lex:
