The types of products, which fall within the scope of the Regulation, are set out in Article 3 and the Annex to that Regulation.įor generic and hybrid medicinal products eligibility can be granted to the Centralised procedure as follows: Regulation (EC) No 726/2004, creates a Centralised Procedure for the authorisation of medicinal products, for which there is a single application, a single evaluation and a single authorisation allowing direct access to the single European Union market.
Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text. Marketing authorisation holders must in all cases comply with the requirements of Community legislation. These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants. Revised topics are marked 'New' or 'Rev.' on publication. The Q&As are updated regularly to reflect new developments, to include guidance on further pre-authorisation procedures and to reflect the implementation of new European legislation. Theses Q&As complement the Agency's pre-authorisation guidance. To help applicants, EMA has published questions and answers (Q&As) on its position on issues applicants preparing to request marketing authorisation for generic or hybrid medicines typically raise. The European Medicines Agency (EMA) assesses applications from companies to market generic medicines in the European Union (EU).
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