13.—(1) Subject to paragraphs (3) and (4), no person shall, in the course of a business carried on by him, sell or supply any investigational medicinal product to—
(a)an investigator,
(b)a health care professional who is a member of an investigator’s team,
(c)a person who provides or is to provide health care under the direction or control of a person referred to in sub-paragraphs (a) and (b), or
(d)a subject,
for the purpose of administering that product in a clinical trial, unless the conditions specified in paragraph (2) are satisfied.
(2) The conditions referred to in paragraph (1) are—
(a)the licensing authority has authorised the clinical trial for the purposes of which the product is sold or supplied;
[F1(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.]
[F2(2A) The condition specified in paragraph (2)(b) does not apply to an investigational medicinal product that has been manufactured or assembled in accordance with the terms of a ... marketing authorization or marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC relating to that product.]
F3(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F4(4) The restriction in paragraph (1) shall not apply to—
(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)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).]
Textual Amendments
F1Reg. 13(2)(b) substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 7(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 1 para. 2(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Reg. 13(2A) inserted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 7(3) (as amended by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 1 para. 2(b)(i)(ii)); 2020 c. 1, Sch. 5 para. 1(1)
F3Reg. 13(3) omitted (31.12.2020) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 7(4); 2020 c. 1, Sch. 5 para. 1(1)
F4Reg. 13(4) substituted (31.12.2020) by S.I. 2019/744, reg. 7(5) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 1 para. 2(c))