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Regulation 174 provides an exemption to the requirement for authorisation of Regulation 46, allowing for the sale or supply of any medicinal product to be temporarily authorised by the licensing authority (MHRA) in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation. [6]
The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (SI 2020/1125) is a statutory instrument (SI) that was laid before Parliament on 16 October 2020 to make provision for the strengthening of existing regulations that allow for the temporary authorisation of the supply of unlicensed medicines, including vaccines, in response to certain public health threats, and for ...
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
This was in the form of a temporary authorisation given by the Medicines and Healthcare products Regulatory Agency (MHRA) under Regulation 174 of the Human Medicines Regulations 2012. [39] Regulatory approval is reserved under the devolution settlement.
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.
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 Center Square) – Hemp businesses advocating for responsible industry wide regulations urge Illinois lawmakers to reject an Illinois Department of Agriculture proposed rule regulating hemp.
The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be ...