1. Ravimiamet väljastab ravimitootjatele ja hulgimüügiettevõtetele ravimite müügilubasid, ravimite impordi- või ekspordilubasid ning kontrollib narkootiliste ja psühhotroopsete ravimite importi, eksporti, säilitamist ja kasutamist.
2. Müügiloa taotleja (edaspidi taotleja) on ravimitootja, kes taotleb müügiluba oma tootele. Müügiloa hoidja on ravimitootja, kellele on väljastatud ravimpreparaadi müügiluba (edaspidi müügiluba). Müügiloa hoidja peab tagama registreeritud ravimi kättesaadavuse ja selle vastavuse tingimustele, mille alusel väljastati müügiluba.
Only after a single scientific evaluation of the highest possible standard of the quality, safety or efficacy of technologically advanced medicinal products, to be undertaken within the European Agency for the Evaluation of Medicinal
Products, should a marketing authorization be granted by the Community by a rapid procedure ensuring close cooperation between the Commission and Member States. ... The Committee for Proprietary Medicinal Products established by Article 8
of Directive 75/319/EEC, in this Title referred to as 'the Committee', shall be responsible for formulating the opinion of the Agency on any question concerning the admissibility of the files submitted in accordance with the centralized
procedure, the granting, variation, suspension or withdrawal of an authorization to place a medicinal product for human use on the market arising in accordance with the provisions of this Title and pharmacovigilance.
