Human Medicines Regulations 2012

Human Medicines Regulations 2012
	Statutory Instrument
Citation	2012 No. 1916
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Repealed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	Directive 2010/84/EU
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Text of statute as originally enacted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 Secretary of State and the Minister for Health, Social Services and Public Safety 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 The HMR partially repealed the Medicines Act 1968 in line with EU legislation.[1][2][3][4]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 Please note that the Human Medicines Regulations 2012 repealed aspects of the Medicines Act 1968 as follows...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

Official website

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[rpshmr-1] "How will the new Human Medicines Regulations affect your practice?". Royal Pharmaceutical Society. 3 August 2012.

[rpsmep-2] Medicines, Ethics and Practice 39: The professional guide for pharmacists. Royal Pharmaceutical Society of Great Britain. 18 July 2015. p. 25.

[aw13-3] Appelbe, Gordon E.; Wingfield, Joy (2013). Dale and Appelbe's Pharmacy and Medicines Law (10 ed.). Pharmaceutical Press. p. 22. ISBN 9780853699897.

[4] "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...

[5] 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.