Point in time view as at 06/11/2023.
The Medicines for Human Use (Clinical Trials) Regulations 2004, Paragraph 4 is up to date with all changes known to be in force on or before 04 March 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
4.—(1) Section 8 of the Act (provisions as to manufacture and wholesale dealing) shall be amended as follows.U.K.
(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 F1.”.
(4) In subsections (3) and (3A) F2, 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.”.
Textual Amendments
F1OJ No. L214, 24.8.1993, p.1.
F2Subsections (3A) to (3C) of section 8 were inserted by regulation 2(4) of S.I. 1993/834
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