Paragraph 5

(1)

This sub-paragraph applies where—

(a)

a clinical trial is conducted after 30th April 2004;

(b)

the investigational medicinal product used in the trial is a product with a marketing authorization;

(c)

the trial has before 1st May 2004 been notified to the licensing authority by the person supplying the product for the purposes of that trial; and

(d)

the licensing authority has before 1st May 2004 notified that person that—

(i)

the trial appeared to fall within the terms of the Medicines (Exemption from Licences) (Clinical Trials) Order 1974 M1, and

(ii)

the authority agreed to the trial proceeding.

(2)

Where sub-paragraph (1) applies—

(a)

the trial shall be treated for the purposes of these Regulations as having been authorised by the licensing authority;

(b)

regulations 17 to 21 shall not apply in relation to the trial; and

(c)

regulations 11, 24(2), 29, 31 and 45(1), and Schedule 7, shall apply in relation to the trial with the modification that references to the request for authorisation shall be read as references to the notification referred to in sub-paragraph (1)(c).

Annotations

Marginal citations

M1: S.I. 1974/498.