News about GMP/cGMP

07.12.2018

European Council Adopts Animals Medicines Package

As stated in a European Council press release on 26 November, the Council of the EU adopted the "Veterinary Medicinal Products Package" with two new Regulations in the following areas:

veterinary medicinal products
the manufacture, placing on the market and use of medicated feed

and changes to the existing rules laying down procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

Currently, Directive 2001/82/EC and Regulation 726/2004 provide the legal framework for the authorisation, distribution and use of veterinary medicinal products. Directive 2001/82/EC will be repealed by the new EU veterinary regulation. Regulation 726/2004, establishing the European Medicines Agency and laying down the centralised procedure for the authorisation and supervision of medicinal products will be adapted to avoid any overlap with the procedures laid down in the new veterinary Regulation.

The EU is thus introducing new and improved rules to combat antimicrobial resistance more effectively and to improve the availability and safety of veterinary medicinal products and medicated feed. Antimicrobial agents and antibiotics must therefore be used more prudently in future.

As a next step, the adopted regulations must be signed by the Council and the European Parliament. The signed texts will then be published in the EU Official Journal and will enter into force 20 days later. However, the new rules will not come into full force until the end of 2021.

Click here for the European Council press release with more background information.