The Human Medicines Regulations 2012

[F1 Manufacturing and assembly U.K.

37.— (1) This regulation applies in relation to a manufacturer’s licence relating to the manufacture or assembly of medicinal products.

(2) The licence holder must comply with the principles and guidelines for good manufacturing practice set out in the Good Manufacturing Practice Directive [F2 which apply under or by virtue of regulation B17].

(3) Unless paragraph (10) applies, the licence holder shall use active substances as starting materials only if—

(a) those substances have been manufactured in accordance with good manufacturing practice for active substances; and

(b) those substances have been distributed in accordance with the guidelines on good distribution practice for active substances.

(4) The licence holder shall verify—

(a) that the manufacturer or distributor of an active substance used by the licence holder has complied with the requirements of good manufacturing practice and good distribution practice for active substances by means of audits performed—

(i) directly by the licence holder, or

(ii) by a person acting on behalf of the licence holder under a contract;

[F3 (b) that unless the active substance is imported into Great Britain from a country other than an approved country for import or into Northern Ireland from a country other than an EEA State from a third country, any manufacturers, importers or distributors supplying active substances to the licence holder—

(i) in the case of a product imported into Great Britain, are registered with the appropriate authority for the registration of such persons in the approved country for import, and

(ii) in the case of a product imported into Northern Ireland, are registered with the competent authority of a member State in which they are established; and]

(c) the authenticity and quality of the active substance.

(5) The licence holder shall ensure that—

(a) excipients are suitable for use in a medicinal product by—

(i) ascertaining what the appropriate good manufacturing practice is, and

(ii) ensuring that the ascertained good manufacturing practice is applied;

(b) the suitability of the excipient is ascertained on the basis of a formalised risk assessment as described [F4 in the case of a product for sale or supply in Great Britain [F5 (including a listed NIMAR product for sale or supply from Great Britain to Northern Ireland)], in the guidelines which apply under or by virtue of regulation C17 and, in the case of a product for sale or supply in Northern Ireland,] in paragraph 5 of Article 47 of the 2001 Directive;

(c) the assessment under sub-paragraph (b) takes account of—

(i) the source,

(ii) requirements under other quality systems,

(iii) intended use of the excipients, and

(iv) previous instances of quality defects,

(d) the authenticity and quality of any excipient used is verified; and

(e) the measures taken under this paragraph are documented by the licence holder.

(6) The licence holder must maintain such staff, premises and equipment as are necessary for the stages of manufacture and assembly of medicinal products undertaken by the licence holder in accordance with—

(a) the manufacturer’s licence; F6 ...

[F7 (aa) in the case of a product for supply as an EAMS medicinal product, the conditions attached to the EAMS scientific opinion in respect of the product; and]

(b) [F8 in the case of a product for sale or supply—

(i) in Great Britain [F9 (including a listed NIMAR product for sale or supply from Great Britain to Northern Ireland)], the UKMA(GB), UKMA(UK), COR(GB), COR(UK), THR(GB) or THR(UK), or

(ii) in Northern Ireland, the UKMA(NI), UKMA(UK), COR(NI), COR(UK), THR(NI), THR(UK), EU marketing authorisations or Article 126a authorisations,

applying to the medicinal products.]

(7) The licence holder must not manufacture or assemble medicinal products, or classes of medicinal products, other than those specified in the licence.

(8) The licence holder must not manufacture or assemble medicinal products on premises other than those specified in the licence as approved by the licensing authority for the purpose.

(9) The licence holder must ensure that blood, or blood components, imported into the United Kingdom and used as a starting material or raw material in the manufacture of a medicinal product meet—

(a) the standards of quality and safety specified in [F10 the Blood Quality and Safety Regulations 2005]; or

(b) equivalent standards.

(10) The requirements in paragraphs (3) to (5) do not apply in relation to the manufacture or assembly of special medicinal product to which regulation 167 (supply to fulfil special needs) applies [F11 or an EAMS medicinal product to which regulation 167E(1) to (4) (EAMS medicinal product: manufacture, assembly, importation, distribution and supply) applies].

(11) The licence holder must immediately inform the [F12 licensing authority] and, where applicable, the [F13 UK] marketing authorisation holder, of medicinal products which come within the scope of manufacturing authorisation which the licence holder—

(a) knows or suspects; or

(b) has reasonable grounds for knowing or suspecting,

to be falsified.]

Textual Amendments

F1 Reg. 37 substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 11

F2 Words in reg. 37(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 28(1A) (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 18(a)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Reg. 37(4)(b) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 28(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 18(b))

F4 Words in reg. 37(5)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 28(3) (as substituted by S.I. 2020/1488, reg. 1, Sch. 2 para. 18(c)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in reg. 37(5)(b) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 8

F6 Word in reg. 37(6)(a) omitted (15.4.2022) by virtue of The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 5(2)(a) (with reg. 19)

F7 Reg. 37(6)(aa) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 5(2)(b) (with reg. 19)

F8 Reg. 37(6)(b) substituted (31.12.2020) by S.I. 2019/775, regs. 1, 28(4) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 18(d))

F9 Words in reg. 37(6)(b)(i) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 8

F10 Words in reg. 37(9)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 28(5); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in reg. 37(10) inserted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 5(3) (with reg. 19)

F12 Words in reg. 37(11) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 28(6)(a); 2020 c. 1, Sch. 5 para. 1(1)

F13 Word in reg. 37(11) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 28(6)(b); 2020 c. 1, Sch. 5 para. 1(1)