The Human Medicines Regulations 2012
| Year | 2012 |
2012 No. 1916
Medicines
The Human Medicines Regulations 2012
Made 19th July 2012
Laid before Parliament 24th July 2012
Coming into force 14th August 2012
The Secretary of State and the Minister for Health, Social Services and Public Safety make the following Regulations. They do so in exercise of the powers conferred by section 2(2) and (5) of the European Communities Act 19721, having been designated for the purposes of section 2(2) of that Act in relation to medicinal products2and to measures in the veterinary and phytosanitary fields for the protection of public health3. They do so in exercise also of the powers conferred by sections 87(1), 88(1) and (2), 91(2), and 129(1), (2) and (5) of the Medicines Act 19684, having consulted such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations in accordance with section 129(6) of that Act.
PART 1
General
Citation and commencement
1.—(1) These Regulations may be cited as the Human Medicines Regulations 2012.
(2) These Regulations come into force on 14th August 2012.
Medicinal products
2.—(1) In these Regulations “medicinal product” means—
(a)
(a) any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or
(b)
(b) any substance or combination of substances that may be used by or administered to human beings with a view to—
(i) restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or
(ii) making a medical diagnosis.
(2) These Regulations do not apply to—
(a)
(a) whole human blood; or
(b)
(b) any human blood component, other than plasma prepared by a method involving an industrial process.
Scope of these Regulations: special provisions
3.—(1) Regulation 17(1) (manufacturing of medicinal products: requirement for licence) shall not apply in circumstances where paragraph (4) applies.
(2) Regulations 17(1) (manufacturing of medicinal products: requirement for licence) and 46 (requirement for authorisation) shall not apply in circumstances where paragraph (5) or (6) applies.
(3) These Regulations do not apply where paragraph (7) applies.
(4) This paragraph applies where a medicinal product is assembled by a registered nurse or a registered midwife if—
(a)
(a) the nurse or midwife is acting in the course of his or her profession; and
(b)
(b) the conditions in paragraphs (8) and (9) are met.
(5) This paragraph applies where a medicinal product is manufactured or assembled by a doctor or dentist and the conditions in paragraphs (8) and (9) are met.
(6) This paragraph applies where a herbal medicinal product is manufactured or assembled by a person (“A”) if—
(a)
(a) the manufacture or assembly takes place on premises occupied by A and from which A can exclude the public;
(b)
(b) the product is for administration to a person (“B”) and A has been requested by or on behalf of B, and in B’s presence, to use A’s judgment as to the treatment required;
(c)
(c) the product does not contain a substance specified in Part 1 of Schedule 20;
(d)
(d) the product does not contain a substance listed in Part 2 of that Schedule, unless the product is sold or supplied—
(i) in or from containers or packages labelled to show a dose not exceeding the maximum dose or maximum daily dose specified in column 2 of that Part, or
(ii) in the case of a product for external use only, with a percentage of the substance in the product that does not exceed the percentage specified in column 3 of that Part; and
(e)
(e) the condition in paragraph (9) is met.
(7) This paragraph applies where the product is a radionuclide that is in the form of a sealed source.
(8) This condition is that the medicinal product is supplied—
(a)
(a) to a patient in the course of the treatment of that patient; or
(b)
(b) in a case to which paragraph (5) applies, to a patient of another doctor or dentist who is a member of the same medical or dental practice.
(9) This condition is that the medicinal product is not manufactured or, as the case may be, assembled—
(a)
(a) on a large scale; or
(b)
(b) by an industrial process.
(10) Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products) does not apply to a medicinal product that is sold or supplied in circumstances where paragraph (11) or (12) applies in relation to the product, except to the extent set out in paragraph (14), but the requirements of paragraph (13) shall apply.
(11) This paragraph applies where a medicinal product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of paragraph (5) or (6).
(12) This paragraph applies in the case of a medicinal product where—
(a)
(a) the product is the result of a process of assembly of an authorised medicinal product;
(b)
(b) regulation 17(1) does not apply to the process of assembly by virtue of paragraph (4) or (5);
(c)
(c) the process of assembly results in a change in the presentation of the authorised medicinal product; and
(d)
(d) by reason of that change the product so assembled is not sold or supplied in accordance with the terms of—
(i) the marketing authorisation,
(ii) the certificate of registration,
(iii) the traditional herbal registration, or
(iv) the Article 126a authorisation,
that relates to the authorised medicinal product.
(13) The information specified in Part 1 of Schedule 26 must appear on the outer packaging, or, if there is no outer packaging, on the immediate packaging of a medicinal product that is sold or supplied in circumstances—
(a)
(a) where paragraph (11) applies to the product, except in the case of a product manufactured in accordance with paragraph (6); or
(b)
(b) where paragraph (12) applies in relation to the product.
(14) Regulations 269 (offences relating to packaging and package leaflets: other persons) and 271 (offences: penalties) shall have effect in relation to paragraph (13) as if that paragraph were a requirement of Part 13.
(15) For the purposes of this regulation and regulation 4 (special provisions for pharmacies etc), a medicinal product is authorised if there is in force for the product—
(a)
(a) a marketing authorisation;
(b)
(b) a certificate of registration;
(c)
(c) a traditional herbal registration; or
(d)
(d) an Article 126a authorisation.
Special provisions for pharmacies etc
4.—(1) Regulations 17(1) (manufacturing of medicinal products: requirement for licence) and 46 (requirement for authorisation) do not apply where any provision of section 10 of the Medicines Act 19685so provides.
(2) Chapter 1 of Part 13 (requirements for packaging and package leaflets relating to medicinal products) does not apply to a medicinal product that is sold or supplied in circumstances where paragraph (3) or (4) applies in relation to the product, except to the extent set out in paragraph (6), but the requirements of paragraph (5) shall apply.
(3) This paragraph applies in a case where a medicinal product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of any provision of section 10 of the Medicines Act 1968.
(4) This paragraph applies in the case of a medicinal product where—
(a)
(a) the product is the result of a process of assembly of a medicinal product that is an authorised medicinal product within the meaning of regulation 3(15);
(b)
(b) regulation 17(1) does not apply to the process of assembly by virtue of any provision of section 10 of the Medicines Act 1968;
(c)
(c) the process of assembly results in a change in the presentation of the authorised medicinal product; and
(d)
(d) by reason of that change the product so assembled is not sold or supplied in accordance with the terms of—
(i) the marketing authorisation,
(ii) the certificate of registration,
(iii) the traditional herbal registration, or
(iv) the Article 126a authorisation,
that relates to the authorised medicinal product.
(5) The information specified in Part 2 of Schedule 26 must appear on the outer packaging, or, if there is no outer packaging, on the immediate packaging of a medicinal product that is sold or supplied in circumstances where paragraph (3) or (4) applies in relation to the product.
(6) Regulations 269 (offences relating to packaging and package leaflets: other persons) and 271 (offences: penalties) shall have effect in relation to paragraph (5) as if that paragraph were a requirement of Part 13.
Classification of medicinal products
5.—(1) In these Regulations references to a medicinal product subject to general sale are to a product that is not a prescription only medicine or a pharmacy medicine but is—
(a)
(a) a product that is covered by an authorisation of which it is a term that the product is to be available on general sale; or
(b)
(b) a product that—
(i) is covered by an EU marketing authorisation, and
(ii) is not classified in the authorisation as a prescription only medicine, and
(iii) the licensing authority has determined should be available on general sale.
(2) In paragraphs (1)(a) and (5)(a) “authorisation” means—
(a)
(a) a UK marketing authorisation;
(b)
(b) a certificate of registration;
(c)
(c) a traditional herbal registration; or
(d)
(d) an Article 126a authorisation.
(3) In these Regulations references to a prescription only medicine are to any of the following—
(a)
(a) a medicinal product that is covered by an authorisation of which it is a term that the product is to be available only on prescription;
(b)
(b) a medicinal product that—
(i) is covered by an EU marketing...
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