Registratie van medicijnen: EU-richtlijnen zorgen voor lagere tarieven en gestroomlijnde regelgeving (en)
New rules on fees for registration of medicines for human and veterinary use at the European Medicines Agency (EMEA) have been adopted by the Council, upon a proposal from the European Commission. A number of fees will be reduced, reinforcing the principle of proportionality between the fees levels and the services provided by the Agency. The new regulation puts the fees system in line with the new pharmaceutical legislation in the EU and the new responsibilities conferred to EMEA. The initial Commission proposal draws on prior impact assessment, taking account of experience with the existing system and extensive consultation with all stakeholders, in particular the pharmaceutical industry. The new rules will enter into force in the coming days, following publication in the Official Journal.
EMEA is a decentralised body of the EU headquartered in London, which started operating in 1995 with the introduction of a European system for authorising medicinal products. It enables companies to obtain marketing authorisation for the whole EU by submitting a single application, which is evaluated by scientific committees gathering the best European experts. The EMEA mission also includes advising companies on their research and development programmes, and providing useful and clear information to patients and healthcare professionals.
The revision of the Community pharmaceutical legislation has a direct impact on EMEA's mission and responsibilities, by introducing new tasks and changing existing ones. The newly adopted rules include:
- A number of fee reductions, e.g. for the evaluation of generics or certain minor changes (variations) in the marketing authorisation dossiers;
- New fees categories for new services provided by the EMEA, e.g. scientific opinions on traditional herbal medicines;
- Extension of the deadline for payment of the fees from 30 to 45 days;
- Further flexibility to adapt certain fees to the type of service and the related costs.
- Increase of maximum threshold for the annual fee, while giving a mandate to the EMEA Management Board to define cases where a reduced annual fee should apply.
Additional financial and administrative incentives for small and medium sized enterprises will be published by the Commission soon.
More information, including the Regulation itself:
http://pharmacos.eudra.org/F2/home.html
See also: http://www.emea.eu.int/