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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
In January 2021, SAHPRA authorised under Section 21 of the Medicines and Related Substances Act, a Compassionate Use Access programme, which gave permission to five importers of unregistered Ivermectin in oral solid dosage form and for health facilities to hold bulk stock. The reasoning for this was to thwart the use of illicit and veterinary ...
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.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
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 ...
MHRA may refer to: Organisations. Medicines and Healthcare products Regulatory Agency, UK; Michigan Hot Rod Association, US; Modern Humanities Research Association, UK
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]