Amendment of regulation 13 (supply of investigational medicinal products for the purpose of clinical trials)U.K.

7.—(1) Regulation 13 is amended as follows.

(2) For paragraph (2)(b) M1, substitute—

[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.”].

(3) After paragraph (2), insert—

“(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 F2... marketing authorization [F3or marketing authorisation issued by the competent authority of an EEA State in accordance with Directive 2001/83/EC] relating to that product.”.

(4) Omit paragraph (3).

[F4(5) For paragraph (4) substitute—

“(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).”.]