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The Medicines for Human Use (Clinical Trials) Regulations 2004

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The Act

4.—(1) Section 8 of the Act (provisions as to manufacture and wholesale dealing) shall be amended as follows.

(2) At the beginning of subsection (2), insert “Subject to subsection (2A) of this section”.

(3) After subsection (2) insert the following subsections—

“(2A) In the case of a medicinal product that is an investigational medicinal product, the restrictions imposed by subsection (2) of this section only apply—

(a)if the product has a product licence or marketing authorization, and

(b)to the extent that the manufacture or assembly of the product is in accordance with the terms and conditions of that licence or authorization.

(2B) In subsection (2A) of this section—

“investigational medicinal product” has the meaning given by the Clinical Trials Regulations; and

“marketing authorization” means—

(a)

a marketing authorization issued by a competent authority in accordance with Directive 2001/83/EC, or

(c)

a marketing authorization granted by the European Commission under Council Regulation (EEC) 2309/93(1).”.

(4) In subsections (3) and (3A)(2), for “subsection (3C)”, in both places those words appear, substitute “subsections (3C) and (3D)”.

(5) After subsection (3C), insert the following subsection—

“(3D) The restrictions imposed by subsections (3) and (3A) of this section do not apply where the product concerned is an investigational medicinal product within the meaning given by the Clinical Trials Regulations.”.

(1)

OJ No. L214, 24.8.1993, p.1.

(2)

Subsections (3A) to (3C) of section 8 were inserted by regulation 2(4) of S.I. 1993/834

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