New legislation for veterinary medicines
European Medicines Agency welcomes European Commission proposal to increase availability of medicines across Europe
New rules have been proposed by the European Commission to improve the health and wellbeing of animals by stimulating the development and availability of veterinary medicines.
The legislative proposal also tackles the growing concerns over antimicrobial resistance by proposing a series of tools to minimise the risks that may arise from the use of antibiotics in veterinary medicine.
The proposal represents a major evolution of the legal framework for the authorisation of veterinary medicines in the European Union (EU).
The document has been published on the Commission’s website together with questions and answers under Revision of the legal framework for veterinary medicinal products.
The revision aims to:
- simplify the regulatory environment and reduce administrative burden for companies developing veterinary medicines through streamlined marketing-authorisation procedures and simplified pharmacovigilance rules;
- stimulate the development of new veterinary medicines, including products for small markets (minor use and minor species), with the introduction of special rules in certain areas such as apiculture and aquaculture and better mechanisms to reward companies’ investments in the development of innovative medicines;
- facilitate the circulation of veterinary medicines across the EU, through streamlined procedures and clear rules for internet retailing of veterinary medicines within the EU;
- fight the development of antimicrobial resistance through specific measures such as a restriction of the use in animals of certain antimicrobials that are reserved for the treatment of infections in people.
The European Medicines Agency welcomes the publication of this proposal as the availability of veterinary medicines and the fight against antimicrobial resistance are two major priorities for the Agency, as reflected in its work programme.
Today, the Commission has also adopted a proposal for a revision of the EU legislation on food for animals containing medication. The aim is to ensure that medicated feed is only produced by approved manufacturers using authorised veterinary medicines.
Other EU institutions, including the European Parliament and the Council, will now consider the Commission’s proposals and will adopt their positions in due course, in accordance with the co-decision procedure.
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