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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 MHRA has several independent advisory committees which provide the UK Government with information and guidance on the regulation of medicines and medical devices. There are currently eight such committees: [citation needed] Advisory Board on the Registration of Homeopathic Products; Herbal Medicines Advisory Committee; The Review Panel
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.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
will maintain guidance documents on the format and content of applications to assist applicants in their preparation. (a) Application form. The applicant shall submit a completed and signed application form that contains the following: (1) The name and address of the applicant; the date of the application;
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 ...
It is run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines. It was extended to hospital pharmacists in 1997, and to community pharmacists in 1999. [2] The Yellow Card Centre Scotland is a joint venture between MHRA and the Scottish Government. [3]
MHRA may refer to: Organisations. Medicines and Healthcare products Regulatory Agency, UK; Michigan Hot Rod Association, US; Modern Humanities Research Association, UK