The Human Medicines Regulations 2012

Enforcement in England, Wales and Scotland U.K.

323.—(1) The Secretary of State must enforce or secure the enforcement of these Regulations and the relevant EU provisions in England, Wales and Scotland.

(2) The Secretary of State may make arrangements for either or both of—

(a) the General Pharmaceutical Council; or

(b) in respect of each area for which there is a drugs authority, the drugs authority for the area,

to enforce the provisions of these Regulations listed in paragraph (3) to the extent specified in the arrangements.

(3) The provisions referred to in paragraph (2) are—

(a) regulations 251 (compliance with standards specified in certain publications) and 255(1)(e) (offences relating to dealings with medicinal products: compliance with standards specified in certain publications);

(b) Part 13 (packaging and leaflets); F1 ...

(c) Part 14 Chapter 2 (requirements relating to advertising); [F2 and

(d) regulation 255A (enforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public).]

(4) Arrangements made with the General Pharmaceutical Council under paragraph (2)(a) in relation to Part 14 Chapter 2 are to be limited to the enforcement of those provisions in respect of—

(a) advertisements displayed or representations made on or in any premises where medicinal products are sold by retail or supplied in circumstances corresponding to retail sale;

(b) advertisements displayed on any web site associated with such premises; and

(c) advertisements displayed on, or in close proximity to, a vending machine in which medicinal products are offered or exposed for sale.

[F3 (4A) Arrangements made with the General Pharmaceutical Council under paragraph (2)(a) in relation to regulation 255A are to be limited to the enforcement of that provision in respect of medicinal products sold or supplied, or offered for sale or supply, from premises that are registered pharmacies.]

(5) The General Pharmaceutical Council must continue to enforce—

(a) regulations 214 (sale or supply of prescription only medicines) and 220 (sale or supply of medicines not subject to general sale); and

(b) in their application to or in relation to premises that are registered pharmacies, the provisions of these Regulations to which paragraph (7) applies.

(6) In each area for which there is a drugs authority, that drugs authority must continue to enforce the provisions of these Regulations to which paragraph (7) applies in their application to or in relation to premises that are not registered pharmacies.

(7) This paragraph applies to regulations 221 (sale or supply of medicinal products subject to general sale) and 222 (sale of medicinal products from automatic machines).

(8) Functions conferred by virtue of paragraphs (2), (5) and (6) are to be exercised concurrently with the Secretary of State.

(9) Nothing in this regulation confers a function on a person in relation to—

(a) a hospital (except so much of the hospital as is a registered pharmacy); or

(b) so much of any premises as is used as a doctor's or dentist's practice.

(10) In this regulation “drugs authority” means—

(a) in England—

(i) in relation to a non-metropolitan county, metropolitan district or London borough, the council of that county, district or borough, and

(ii) in relation to the City of London (including the Inner Temple and the Middle Temple), the Common Council of the City of London;

(b) in Wales, the council of a county or county borough; and

(c) in Scotland, a council constituted in relation to a local government area under section 2 of the Local Government etc (Scotland) Act 1994 M1 .

(11) In this Part “premises” includes—

(a) any place; and

(b) a ship, aircraft, hovercraft or vehicle.

(12) Nothing in this regulation is to be construed as authorising any person other than the Lord Advocate or a procurator fiscal to institute proceedings in Scotland for an offence.

Textual Amendments

F1 Word in reg. 323(3)(b) omitted (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 14(a)(i) and word in reg. 323(3)(b) omitted (N.I.) (9.2.2019) by virtue of The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 14(a)(i)

F2 Reg. 323(3)(d) and preceding word inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 14(a)(ii) and reg. 323(3)(d) and preceding word inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 14(a)(ii)

F3 Reg. 323(4A) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 14(b) and reg. 323(4A) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 14(b)

Modifications etc. (not altering text)

C1 Reg. 323(1) applied (with modifications) by The Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg 47(1), Sch. 9 (as substituted (14.8.2012) by S.I. 2012/1916, reg. 1(2), Sch. 34 paras. 57(b), 64 (with Sch. 32))

Marginal Citations

M1 1994 c.39. There is an amendment to section 2(1) that is not relevant to this regulation.