SCHEDULE 1
Regulation 3
Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
Amendment of the Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019
1. In regulation 3 (amendment of regulation 2 (interpretation))—
(a) in paragraph (2), for the substituted definition of “Commission Directive 2003/94/EC” substitute—
““Commission Directive 2003/94/EC”, other than in Parts 2 and 3 of Schedule 7, means—
(a) in the case of an investigational medicinal product manufactured or assembled in, or imported into, Great Britain—
(i) Commission Directive 2003/94/EClaying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use, as modified by Schedule 2A to the 2012 Regulations, or
(ii) if Regulations have been made under the powers in regulation B17(1) of the 2012 Regulations, and have come into force, those Regulations;
(b) in the case of an investigational medicinal product manufactured or assembled in, or imported into, Northern Ireland, Commission Directive 2003/94/EClaying down the principles and guidelines of good manufacturing practice for medicinal products for human use and for investigational medicinal products for human use;”;
(b) in paragraph (6), for the substituted definition of “import” substitute—
““import”, except in regulation 13 and Schedule 13, means import, or attempt to import—
(a) into Great Britain other than from Northern Ireland, or
(b) into Northern Ireland from a country other than an EEA State,
whether by land, sea or air and “imported” is to be construed accordingly;;”;
(c) omit paragraph (7);
(d) in paragraph (8), for the substituted definition of “marketing authorization” substitute—
““marketing authorization” means—
(a) a UK marketing authorization,
(b) an EU marketing authorisation (as defined in the 2012 Regulations), or
(c) an authorization granted by a regulatory body responsible for licensing medicinal products in a country that is included in the list referred to in regulation 2A(1);”;
(e) omit paragraph (9);
(f) in paragraph (11), for the inserted definition of “UK marketing authorization” substitute—
““UK marketing authorization”—
(a) has the same meaning as “UK marketing authorisation” in the 2012 Regulations (and references to “UKMA(UK)”, “UKMA(GB)” and “UKMA(NI)” in these Regulations should be construed in accordance with that definition); and
(b) includes a product licence granted by the licensing authority for the purposes of section 7 of the Medicines Act 1968;”.
2. In regulation 7 (amendment of regulation 13 (supply of investigational medicinal products for the purpose of clinical trials))—
(a) in paragraph (2), for the inserted sub-paragraph (b), substitute—
“(b)
“(b) in the case of—
(i) an investigational medicinal product manufactured or assembled in the United Kingdom, the product has been manufactured or assembled—
(aa) in accordance with the terms of a manufacturing authorisation, or
(bb) in the case of assembly only, under the exemption in regulation 37;
(ii) an investigational medicinal product imported into Northern Ireland from an EEA State—
(aa) the product has been manufactured, assembled or imported into an EEA State in accordance with the terms of an authorisation referred to in Article 13 of the Directive granted by a competent authority of an EEA State, and
(bb) the production batch of investigational medicinal products of which the product is a part has been checked and certified by a qualified person pursuant to Article 13(3) and (4) of the Directive;
(iii) an investigational medicinal product imported into Northern Ireland from a country other than an EEA State, the product has been imported into Northern Ireland in accordance with the terms of a manufacturing authorisation;
(iv) an investigational medicinal product imported into Great Britain other than from Northern Ireland, the product has been imported in accordance with the terms of a manufacturing authorisation.”;
(b) in paragraph (3), in the inserted paragraph (2A)—
(i) omit “UK”;
(ii) after “marketing authorization” insert “or marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC”;
(c) for paragraph (5) substitute—
“5 For paragraph (4) substitute—
“(4) The restriction in paragraph (1) shall not apply to—
(a)
(a) the sale or supply of a medicinal product in Great Britain in accordance with the terms of a UKMA(GB) or UKMA(UK), and
(b)
(b) the sale or supply of a medicinal product in Northern Ireland in accordance with—
(i) the terms of a UKMA(NI) or UKMA(UK), or
(ii) an EU marketing authorisation (as defined in the 2012 Regulations).”.”.
3. For regulation 17 (amendment of regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products)) substitute—
“17. In regulation 36(2), after “marketing authorization” insert “or marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC”.”.
4. For regulation 18 (amendment of regulation 43 (qualified persons)) substitute—
“18. In regulation 43—
(a) for paragraphs (1) and (2) substitute—
“(1) Subject to paragraphs (4) and (5), the holder of a manufacturing authorisation must have at his disposal the services of at least one qualified person—
(a) where the manufacturing authorisation relates wholly to the import of an investigational medicinal product into Great Britain from an approved country for import, who must operate and be ordinarily resident in either the United Kingdom or an approved country for import, or
(b) in any other case, who must operate and be ordinarily resident in the United Kingdom, and
who is responsible for carrying out the duties referred to in paragraph 2.
(2) Subject to paragraphs (2A) and (2C), the qualified person is responsible for ensuring that—
(a) in the case of an investigational medicinal product manufactured in Northern Ireland, each production batch has been manufactured and checked in compliance with—
(i) the requirements of these Regulations;
(ii) the principles and guidelines of good manufacturing practice;
(iii) the product specification, as defined in Part 1 of Schedule 7; and
(iv) the request, particulars and documents submitted to the licensing authority under regulation 17 in respect of the clinical trial in which the product is to be used;
(b) in the case of an investigational medicinal product manufactured in Great Britain, each production batch has been manufactured and checked in compliance with—
(i) the requirements of these Regulations;
(ii) the principles and guidelines of good manufacturing practice, as modified by Schedule 2A to the 2012 Regulations or any regulations made under the power in regulation B17(1) of those Regulations;
(iii) the product specification, as defined in Part 1 of Schedule 7; and
(iv) the request, particulars and documents submitted to the licensing authority under regulation 17 in respect of the clinical trial in which the product is to be used;
(c) in the case of an investigational medicinal product imported into Northern Ireland from a country other than an EEA State, each production batch has been manufactured and checked in compliance with—
(i)...
