The Human Medicines Regulations 2012

[F1 Requirements for registration as an importer, manufacturer or distributor of an active substance U.K.

45O.— [F2 (1) Where principles and guidelines of good manufacturing practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance manufactured in Great Britain, a manufacturer in Great Britain must comply with the principles and guidelines of good manufacturing practice for active substances.

(1A) Where the Commission has adopted principles and guidelines of good manufacturing practice under the third paragraph of Article 47 of the 2001 Directive which applies to an active substance manufactured in Northern Ireland, a manufacturer in Northern Ireland must comply with the principles and guidelines of good manufacturing practice for active substances.]

[F3 (2) Where principles and guidelines of good distribution practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance distributed in Great Britain, a distributor in Great Britain must comply with the principles and guidelines of good distribution practice for active substances.

(2A) Where the Commission has adopted principles and guidelines of good distribution practice under the fourth paragraph of Article 47 of the 2001 Directive which applies to an active substance distributed in the Northern Ireland, a distributor in Northern Ireland must comply with the principles and guidelines of good distribution practice for active substances.]

(3) Without prejudice to regulation 37(4) (manufacture and assembly in relation to active substances) and paragraph 9A of Schedule 8 (material to accompany an application for a UK marketing authorisation in relation to an active substance), where the Commission has adopted principles and guidelines of good manufacturing practice under the third paragraph of Article 47 of the 2001 Directive which applies to an active substance imported into [F4 Northern Ireland] and where an active substance is imported [F5 into Northern Ireland from a country other than an EEA State]—

(a) the importer must comply with good manufacturing practice and good distribution practice in relation to the active substance;

(b) the active substances must have been manufactured in accordance with standards which are at least equivalent to good manufacturing practice; and

(c) the active substances must be accompanied by a written confirmation from the competent authority of the [F6 exporting country] of the following—

(i) the standards of manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to good manufacturing practice,

(ii) the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of standards of manufacturing practice at least equivalent to good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in [F7 Northern Ireland], and

(iii) in the event of findings relating to non-compliance, information on such findings is supplied by the [F6 exporting country] to the Union without any delay.

[F8 (3A) Without prejudice to regulation 37(4) and paragraph 9A of Schedule 8, where principles and guidelines of good manufacturing practice have been published under, or apply by virtue of, regulation C17, which apply to an active substance imported into Great Britain other than from Northern Ireland and where an active substance is so imported—

(a) the importer must comply with good manufacturing practice and good distribution practice in relation to the active substance,

(b) the active substances must have been manufactured in accordance with standards which are at least equivalent to good manufacturing practice, and

(c) the active substances must be accompanied by a written confirmation from the competent authority of the exporting country of the following—

(i) the standards of manufacturing practice applicable to the plant manufacturing the exported active substance are at least equivalent to good manufacturing practice,

(ii) the manufacturing plant concerned is subject to regular, strict and transparent controls and to the effective enforcement of standards of manufacturing practice at least equivalent to good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in Great Britain, and

(iii) in the event of findings relating to non-compliance, information on such findings is supplied by the exporting country to the licensing authority without any delay.]

(4) Paragraph [F9 (3)(c) and (3A)(c) do] not apply—

(a) where the country from where the active substance is exported is included in the list referred to in Article 111b of the 2001 Directive [F10 (in the case of an import into Northern Ireland) or paragraph (6) (in the case of an import into Great Britain)]; or

(b) for a period not exceeding the validity of the certificate of good manufacturing practice, where—

(i) in relation to a plant where active substances are manufactured where the competent authority of a member State [F11 or licensing authority (in the case of an import into Northern Ireland) or licensing authority or an appropriate authority responsible for the licensing of medicinal products in a country included in a list under paragraph (6) (in the case of an import into Great Britain)] has found, upon inspection, that a plant complies with the principles and guidelines of good manufacturing practice, and

(ii) the licensing authority is of the opinion that it is necessary to waive the requirement to ensure availability of the active substance.

(5) The criteria in this regulation apply regardless of whether an active substance is intended for export.]

[F12 (6) The licensing authority may publish a list of countries which it is satisfied have a regulatory framework applicable to active substances exported to Great Britain that is equivalent to the regulatory framework in Great Britain, in that the respective control and enforcement activities in those countries ensures an equivalent level of protection of public health.

(7) Before including a country in the list under paragraph (6), the licensing authority must assess the equivalence referred to in that paragraph by—

(a) reviewing relevant documentation; and

(b) unless the country is included in the approved country for batch testing list, carrying out—

(i) an on-site review of the country's regulatory system, and

(ii) if the licensing authority considers it necessary, an inspection of one or more of that country's manufacturing sites for active substances.

(8) In carrying out an assessment under paragraph (7) the licensing authority must in particular take account of the—

(a) country's rules for good manufacturing practice;

(b) regularity of inspections to verify compliance with good manufacturing practice;

(c) effectiveness of enforcement of good manufacturing practice; and

(d) regularity and rapidity of information provided by that country relating to non-compliant producers of active substances.

(9) The licensing authority must—

(a) review the list under paragraph (6) to determine if a country included in it still satisfies the requirements for inclusion in the list, and if it is not so satisfied, remove that country; and

(b) undertake such a review at least every three years, beginning with the date on which a country is included in the list .]

Textual Amendments

F1 Pt. 3 Chs. 3, 4 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 16

F2 Reg. 45O(1)(1A) substituted for reg. 45O(1) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(2) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(a)); 2020 c. 1, Sch. 5 para. 1(1)

F3 Reg. 45O(2)(2A) substituted for reg. 45O(2) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(3) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(b)); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in reg. 45O(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c)); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in reg. 45O(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c)); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 45O(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4)(c) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c)); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in reg. 45O(3)(c)(ii) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4)(d) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c)); 2020 c. 1, Sch. 5 para. 1(1)

F8 Reg. 45O(3A) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(4A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 32(d))

F9 Words in reg. 45O(4) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(5)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(e)); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in reg. 45O(4)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(5)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(e)); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in reg. 45O(4)(b)(i) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(5)(c) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(e)); 2020 c. 1, Sch. 5 para. 1(1)

F12 Reg. 45O(6)-(9) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 44(6) (as amended by S.I. 2020/1488, Sch. 2 para. 32(f)); 2020 c. 1, Sch. 5 para. 1(1)