Medicines and Medical Devices Act 2021
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Change 1
3 Manufacture, marketing and supply
(1) Regulations under section 2(1) may make provision about— (a) authorisations to manufacture human medicines, (b) authorisations to import human medicines, (c) authorisations to distribute human medicines by way of wholesale dealing, (d) marketing authorisations, (e) manufacturing, importing or distributing active substances, (f) brokering in relation to human medicines, (g) the registration of the premises of pharmacy businesses, (h) the recording of information about the supply of human medicines, (i) notification and reporting requirements in relation to human medicines that have been placed on the market, (j) the labelling and packaging of human medicines or the information that must be supplied with them or made available in relation to them, (k) advertising with regard to human medicines, (l) the registration of persons who supply or offer to supply human medicines by means of the internet, (m) the requirements that must be met in relation to a prescription, (n) prohibitions in the provisions mentioned in subsection (2), or (o) the use of tissues or cells (within the meanings given by regulation 5(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523)) in relation to human medicines. (2) Subsection (1)(n) refers to the following provisions in the Human Medicines Regulations 2012 (S.I. 2012/1916)— (a) regulation 214 and Schedule 13 (sale or supply of prescription only medicines), (b) regulation 215 and Schedule 14 (prescribing and administration by supplementary prescribers), (c) regulation 220 (sale or supply of human medicines not subject to general sale), (d) regulation 221 and Schedule 15 (sale or supply of medicinal products subject to general sale), and (e) regulation 249 and Schedule 22 (restrictions on persons to be supplied with medicinal products).
3 Manufacture, marketing and supply
(1) Regulations under section 2(1) may make provision about— (a) authorisations to manufacture human medicines, (b) authorisations to import human medicines, (c) authorisations to distribute human medicines by way of wholesale dealing, (d) marketing authorisations, (e) manufacturing, importing or distributing active substances, (f) brokering in relation to human medicines, (g) the registration of the premises of pharmacy businesses, (h) the recording of information about the supply of human medicines, (i) notification and reporting requirements in relation to human medicines that have been placed on the market, (j) the labelling and packaging of human medicines or the information that must be supplied with them or made available in relation to them, (k) advertising with regard to human medicines, (l) the registration of persons who supply or offer to supply human medicines by means of the internet, (m) the requirements that must be met in relation to a prescription, (n) prohibitions in the provisions mentioned in subsection (2), or (o) the use of tissues or cells (within the meanings given by regulation 5(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523)) in relation to human medicines. (2) Subsection (1)(n) refers to the following provisions in the Human Medicines Regulations 2012 (S.I. 2012/1916)— (a) regulation 214 and Schedule 13 (sale or supply of prescription only medicines), (b) regulation 215 and Schedule 14 (prescribing and administration by supplementary prescribers), (c) regulation 220 (sale or supply of human medicines not subject to general sale), (d) regulation 221 and Schedule 15 (sale or supply of medicinal products subject to general sale), and (e) regulation 249 and Schedule 22 (restrictions on persons to be supplied with medicinal products).
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