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The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
The Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was rebranded as the Clinical Practice Research Datalink (CPRD). In April 2013, MHRA merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used for ...
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.
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.
The centralised procedure allows companies to submit a single application to the agency to obtain from the European Commission a centralised (or "community") marketing authorisation (MA) valid in all European Union member states and in Iceland, Liechtenstein and Norway. [26]
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
the first has somehow, in some way, been my best year yet. So, as I often say to participants in the workshop, “If a school teacher from Nebraska can do it, so can you!”
MHRA may refer to: Organisations. Medicines and Healthcare products Regulatory Agency, UK; Michigan Hot Rod Association, US; Modern Humanities Research Association, UK