Regulatory Affairs
When people get sick they rely on modern medicine to make them better and this is done without a second thought because they know that the manufacturers have spent years developing their products to ensure their effectiveness and safety. The animal health industry also invests huge resources in developing, testing and manufacturing safe, effective veterinary medicines and Europe has one of the world’s most stringent licensing systems for controlling medicines (see Bringing veterinary medicines to market).
EFFICIENT REGULATION
IFAH-Europe's vision is for a regulatory process that can deliver a true single market for these products via a single European marketing authorisation for all animal health products.
Adherence to common standards at a global level is also important and as such IFAH-Europe promotes a Global Regulatory Strategy for Veterinary Medicines and is active in the VICH, a trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for veterinary product registration.
The links below give more detail on how a single European marketing authorisation could work and the benefits of a more harmonised system for Europe.
The benefits of a single system
A single licensing system for veterinary medicines would mean a more efficient regulatory system, benefitting all stakeholders:
- Efficient use of the European Medicines Regulatory Network’s (EMRN) resources: reducing bureaucracy, removing duplication, attracting/retaining high quality staff
- Workload sharing for the national authorities
- Fair and equitable regulatory environment for all applicants
- Harmonised implementation leading to an efficient and proportionate system
- Better Regulation, giving increased public confidence and reducing administrative burden
- Increased access to EU markets creating business opportunities for small and medium entreprises
- Improved product availability benefiting animal health and welfare through improved access to veterinary medicines for pet owners, vets and farmers
- Enhanced food safety, food security, and protection of public health from zoonotic diseases
- Resources freed to provide market control and surveillance which will increase public confidence in the EMRN
Contact
IFAH-Europe AISBL
168 Ave de Tervueren, Box 8, 5th floor1150 Brussels, Belgium
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