Green light for new rules on veterinary medicines and medicated feed
The EU is introducing new and improved rules to step up the fight against antimicrobial resistance and improve the availability and safety of veterinary medicines and medicated feed. This will be of benefit to animal health and help boost the competitiveness of the EU veterinary pharmaceutical sector.
The Council yesterday adopted the animal medicines package including two new regulations on:
- 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.
This package is a major milestone in the fight against antimicrobial resistance: on the one hand antimicrobials and antibiotics will have to be used much more prudently than is the case now, and on the other hand we encourage the development of better medicines and medicated feed. It is a win-win for public health and the competitiveness of the EU pharmaceutical industry.Elisabeth Köstinger, Austrian Federal Minister for Sustainability and Tourism and President of the Council
The new rules on veterinary medicinal products:
- clarify and simplify the procedures through which a marketing authorisation can be granted to new medicines, thereby reducing the administrative burden for companies, especially small ones
- better frame the use of antimicrobials in animals by further limiting their use for animals that are not yet sick but may run the risk of falling ill, both in the case of prophylaxis and metaphylaxis
- provide for certain critical antimicrobials to be set aside for the treatment of certain infections in humans in order to preserve their effectiveness
- improve the protection of the European consumers against the risk of the spreading of AMR through imports of animals and products of animal origin
- strengthen pharmacovigilance and controls
The new rules on medicated feed:
- set out criteria for the approval of feed business operators and their obligations when manufacturing medicated feed
- lay down harmonised requirements in order to avoid cross contamination of a non target feed with active substances
- clarify the prescription and use of medicated feed containing antimicrobials in food-producing animals
- prohibit the use of medicated feed for prophylaxis
In addition, regulation 726/2004 that establishes the European Medicines Agency and the centralised procedure for the authorisation and supervision of medicinal products is adapted in order to avoid any overlap with the procedures laid down in the new regulation on veterinary medicinal products.
EU responds to antimicrobial resistance
The Council and the European Parliament now need to sign the adopted regulations. 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 only be fully operational as of end of 2021.
The animal medicines package is a package of three proposals for regulations updating the existing legislative framework for veterinary medicines and medicated feed by further tailoring it to the specificities of the animal health sector. While continuing to safeguard public and animal health, animal welfare, food safety and the environment, the package is aimed in particular at increasing the availability of veterinary medicines in the EU, improving the functioning of the EU market, reducing administrative burdens and fostering innovation.
- Regulation of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC
- Regulation of the European Parliament and of the Council 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 of the European Parliament and of the Council 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
- Background: Animal medicines package
- Veterinary medicines: new EU rules to enhance availability and fight against antimicrobial resistance (press release, 13/06/2018)
- Medicated feed: Council's green light wraps up the animal medicines package (press release, 27/06/2018)
Latest News from
Agreement on new rules to fight non cash payment fraud12/12/2018 16:33:00
The EU is stepping up the fight against fraud involving non-cash means of payment (credit cards, online shopping, etc.) by upgrading and modernising the existing rules.
EC approves acquisition of Gemalto by Thales, subject to conditions12/12/2018 15:25:00
The EC has approved under the EU Merger Regulation the proposed acquisition of Gemalto by Thales. The approval is conditional on the divestment of Thales' general purpose hardware security modules business.
EC welcomes the adoption of stronger rules to stop cyber-criminals12/12/2018 14:47:00
The European Parliament and the Council reached political agreement on the EC’s proposal to strengthen rules to combat fraud and counterfeiting of non-cash means of payment – such as bank cards, cheques, mobile payments and virtual currencies.
EC launches Circular Plastics Alliance to foster the market of recycled plastics in Europe12/12/2018 14:10:00
The EC has launched an alliance of key industry stakeholders covering the full plastics value chain as part of its persisting efforts to reduce plastics littering, increase the share of recycled plastics and stimulate market innovation.
VAT: New details on rules for e-commerce presented12/12/2018 13:38:00
The EChas announced new detailed measures that will pave the way for a smooth transition to new VAT (Value-Added Tax) rules for e-commerce that come into force in January 2021.
Council endorses agreement on EU budget for 201912/12/2018 12:25:00
On 11 December 2018, the Council endorsed the agreement reached with the European Parliament on the EU budget for 2019.
Exchanging criminal records: EU agrees a reformed ECRIS system12/12/2018 11:10:00
The EU is introducing new rules to improve the way member states exchange information on convictions of third country nationals.
EDPS welcomes adoption of new data protection rules for EU institutions12/12/2018 10:37:00
The adoption of new data protection rules for the EU institutions and bodies represents another vital step forward in the development of a comprehensive EU framework for data protection in the digital age, the European Data Protection Supervisor (EDPS) has said.
EU negotiators agree on strengthening Europe's cybersecurity11/12/2018 15:25:00
The European Parliament, the Council and the EC have reached a political agreement on the Cybersecurity Act which reinforces the mandate of the EU Agency for Cybersecurity, (European Union Agency for Network and Information and Security, ENISA) so as to better support Member States with tackling cybersecurity threats and attacks.