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In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorisation) or renewal (prolongation) of registration, with the scope of commercialisation or distribution in that country. [2]
The Certification procedure [17] is not compulsory: it is a service that is offered to manufacturers who can submit their CEP [18] in the quality section of a new marketing authorisation (MA) application or a variation of an existing MA. It serves to centralise the evaluation of data for the benefit of both regulatory authorities and industry ...
In a statement, Juul said it looks forward to “re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products.”
The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations ...
John J. Kurz, RMR-CRR, Official Court Reporter Phone 215-683-8035 Fax 215-683-8005 - PLEDGER, et al. -vs- JANSSEN, et al. - 4 1 (Whereupon the Jury resumed
The regulatory tasks carried out by DRAP encompass registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection, laboratory testing, clinical trials oversight, pharmacovigilance, and lot release of biologicals.