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The MHRA is divided into three main centres: [citation needed] MHRA Regulatory – the regulator for the pharmaceutical and medical devices industries; Clinical Practice Research Datalink – licences anonymised health care data to pharmaceutical companies, academics and other regulators for research
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.
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 ...
products.mhra.gov.uk A Product Licence Number (or PL code for short) is a unique identifier on the packaging of medicines, used to uniquely identify the product. This code will normally remain the same despite the varying marketing and branding of the companies selling it.
Medicines for Human Use in the United Kingdom are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). The availability of drugs is regulated by classification by the MHRA as part of marketing authorisation of a product. [citation needed] The United Kingdom has a three-tiered classification system: [citation needed]
to consider representations made in relation to the commission's advice (either in writing or at a hearing) by an applicant or by a licence or marketing authorisation holder; to promote the collection and investigation of information relating to adverse reactions for human medicines (except for those products that fall within the remit of ABRH ...
The Clinical Practice Research Datalink (CPRD) is an observational and interventional research service that operates as part of the Department of Health and Social Care.It is jointly funded by the National Institute for Health and Care Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA).