Brussels, 18/02/2016 (Agence Europe) - After having voted on the question of veterinary medicines, MEPs at the European Parliament's Environment and Public Health Committee reached a decision on the draft regulation for authorising and monitoring veterinary medicines and the remit of the European Medicines Agency (EMA).
It should be pointed out that this legislative proposal was presented at the same time as the one on veterinary medicines in September 2014, in an effort to separate the issue of veterinary medicine marketing authorisations from authorisations for medicines for human use in the 2004 regulation (Regulation 726/2004).
The report by Ciprian Tãnãsescu (S&D, Romania) therefore particularly focuses on the question of the European Medicines Agency's funding, scope and objectives in the new framework provided for veterinary medicines.
It also explains that the revenue from the EMA should also consist of a “contribution from any non-EU country with which the Union has concluded agreements”. It is also proposing to set up a reserve fund “that could help tackle any possible unexpected declines in revenue from fees”.
On the question of the EMA's objectives, MEPs emphasise that the agency should verify whether applicants have complied with the three principles (replacing, reducing and improving) advocated by the directive on experiments on animals. It will also have to introduce ways of validating alternative models in an effort to promote the development of these kinds of models. Still on the question of these objectives, MEPs call on the EMA to produce an annual report on the use of antimicrobials in human and veterinary medicine and the situation involving antimicrobial resistance in the Union. It will also have to maintain an updated list of accredited experts.
It should be pointed out that the Environment and Public Health Committee followed the line advocated by the MEPs in charge of agriculture by retaining a five-year limit on the delegation of powers to the Commission (the power to put forward delegated acts). (Original version in French by Sophie Petitjean)