The Human Medicines Regulations 2012

Product licences of right U.K.

3.—(1) This paragraph applies to a product licence of right. U.K.

(2) In this paragraph, “product licence of right” means a licence of right within the meaning of section 25(4) of the Medicines Act 1968 that—

(a) has been issued in relation to the requirements to hold a product licence contained in section 7(2) of that Act; and

(b) is in force immediately before the coming into force of these Regulations.

(3) A product licence of right shall continue in force, subject to the following sub-paragraphs.

(4) Parts 4 to 11, 13 and 14 of these Regulations shall not apply in relation to a medicinal product that is the subject of a product licence of right, except as provided in the following sub-paragraphs.

(5) A medicinal product to which a product licence of right relates shall—

(a) continue to be classified as a prescription only medicine, a medicinal product not subject to general sale, or a medicinal product subject to general sale, as the case may be, in accordance with the provisions of the Medicines Act 1968 and any statutory instrument made under that Act that was in force immediately before the coming into force of these regulations; and

(b) shall be treated as a prescription only medicine, a pharmacy medicine not subject to general sale, or a medicine subject to general sale respectively, as the case may be, for the purposes of Part 12 of these Regulations.

(6) The provisions listed in sub-paragraph (7), and any provisions to which they refer, shall continue to have effect as they did immediately before the coming into force of these Regulations in relation to a product licence of right and to the product to which it relates.

(7) Those provisions are—

(a) section 28(1), (2) and (3)(a) to (e) and (g) to (j) (general power to suspend, revoke or vary licences) of the Medicines Act 1968 M1 ;

(b) the Medicines (Advertising of Medicinal Products) (No. 2) Regulations 1975 M2 ;

(c) the Medicines (Labelling) Regulations 1976 M3 ;

(d) the Medicines (Leaflets) Regulations 1977 M4 ; and

(e) the Medicines (Labelling and Advertising to the Public) Regulations 1978 M5 .

(8) Part 1 of Schedule 11 (advice and representations) shall have effect where the licensing authority proposes to exercise any power conferred by section 28 of the Medicines Act referred to in sub-paragraph 7(a) in relation to a product licence of right, as if that proposal concerned the suspension, revocation or variation of a UK marketing authorisation, certificate of registration or traditional herbal registration under these Regulations.

(9) Without prejudice to any requirement of Part 1 of Schedule 11 as to the service of notices, where in the exercise of any such power the licensing authority suspends, revokes or varies a product licence of right, it must serve a notice on the holder a notice giving particulars of the suspension, revocation or variation and of the reasons for its decision to suspend, vary or revoke the product licence of right.

(10) Regulations [F1 268 (offences relating to packaging and package leaflets in Great Britain: authorisation holders), 268A (offences relating to packaging and package leaflets in Northern Ireland: authorisation holders), 269 (offences relating to packaging and package leaflets in Great Britain: other persons), 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)] and 271 (offences: penalties) shall have effect in relation to the provisions in sub-paragraph (7)(d) as if—

(a) references to the holder of a marketing authorisation included reference to the holder of a product licence of right; and

(b) the provisions in sub-paragraph (7)(d) were requirements of Part 13.

(11) A product licence of right shall cease to be in force at the same time that a marketing authorisation, certificate of registration or traditional herbal registration is granted in respect of the product to which the product licence of right relates.

Textual Amendments

F1 Words in Sch. 32 para. 3(10) substituted (31.12.2020) by S.I. 2019/775, reg. 224ZD (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 183)

Marginal Citations

M1 Section 28(3) was amended by Schedule 1 to the Animal Health and Welfare Act 1984 (1984 c.40), regulation 4(5) of S.I. 1977/1050, regulation 2(2) of S.I. 1975/1169, regulation 6(2) of S.I. 1994/276, regulation 2(a)(iii) of S.I. 2002/236 and paragraph 14 of Schedule 8 to S.I. 2006/2407.

M2 S.I. 1975/1326, as amended by S.I. 1979/1760 and S.I. 1994/1932.

M3 S.I. 1976/1726, as amended by S.I. 1977/996, S.I. 1977/2168, S.I. 1978/41, S.I. 1978/1140, S.I. 1981/1791, S.I. 1983/1729, S.I. 1985/1558, S.I. 1985/2008, S.I. 1988/1009, S.I. 1989/1183, S.I. 1992/3273, S.I. 1994/104 S.I. 1994/3144, S.I. 2002/236, S.I. 2004/1031, S.I. 2005/2745 and S.I. 2005/2753.

M4 S.I. 1977/1055, as amended by S.I. 1992/3274, S.I. 1994/104, S.I. 1994/3144, and S.I. 2005/2753.

M5 S.I. 1978/41, as amended by S.I. 2004/1771.