Human Medicines Regulations 2012
Statutory Instrument | |
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Citation | 2012 No. 1916 |
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Territorial extent | England |
Dates | |
Made | 19 July 2012 |
Laid before Parliament | 24 July 2012 |
Commencement | 14 August 2012 |
Repealed | |
Other legislation | |
Amends | Medicines Act 1968 |
Transposes | |
Amended by | The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 |
Status: Current legislation | |
Text of statute as originally enacted |
The Human Medicines Regulations 2012 (HMR) in the United Kingdom were created, under statutory authority of the European Communities Act 1972 and the Medicines Act 1968, by the in 2012. The body responsible for their upkeep is the Medicines and Healthcare products Regulatory Agency. The HMR partially repealed the Medicines Act 1968 in line with EU legislation.[1][2][3][4]
Regulation 174[]
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.[5]
References[]
- ^ "How will the new Human Medicines Regulations affect your practice?". Royal Pharmaceutical Society. 3 August 2012.
- ^ Medicines, Ethics and Practice 39: The professional guide for pharmacists. Royal Pharmaceutical Society of Great Britain. 18 July 2015. p. 25.
- ^ Appelbe, Gordon E.; Wingfield, Joy (2013). Dale and Appelbe's Pharmacy and Medicines Law (10 ed.). Pharmaceutical Press. p. 22. ISBN 9780853699897.
- ^ "Legislation covering medicines". Department of Health (N.I.). Retrieved 2020-12-18.
Please note that the Human Medicines Regulations 2012 repealed aspects of the Medicines Act 1968 as follows...
- ^ Dodds-Smith, Ian; Townsend, Ewan (2017). "Unlicencsed Medicinal Products in the UK" (PDF). arnoldporter.com. Thompson Reuters Practical Law. Retrieved 2020-12-19.
Regulation 174 contains an exemption for the sale or supply of products that are authorised by the MHRA on a temporary basis in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents, or nuclear radiation, which may cause harm to human beings.
External links[]
Categories:
- National Health Service
- Pharmaceutics
- Life sciences industry
- Pharmacy
- 2012 establishments in the United Kingdom
- Department of Health and Social Care
- Medical regulation in the United Kingdom
- Biotechnology
- Statutory Instruments of the United Kingdom
- Health law in the United Kingdom
- United Kingdom law stubs