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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.
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
Current Under Secretary Jennifer Moffitt. The Under Secretary for Marketing and Regulatory Programs is a high-ranking position within the United States Department of Agriculture that supervises policy development and day-to-day operations of the Animal and Plant Health Inspection Service, the Agricultural Marketing Service, and the Grain Inspection, Packers, and Stockyards Administration.
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While the patent for Biogen's drug has expired in the United States, it had scored a win in Europe in March after the EU's Court of Justice blocked generic versions of Tecfidera in the region.
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 ...
Baxter Receives Marketing Authorization for HyQvia in European Union BRUSSELS--(BUSINESS WIRE)-- Baxter International Inc. (NYS: BAX) and Halozyme Therapeutics, Inc., (NAS: HALO) today announced ...
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 ...