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SCHEDULE 12TRANSITIONAL PROVISIONS

Clinical trial exemptions or notifications prior to 1st May 2004

3.—(1) This sub-paragraph applies where—

(a)a clinical trial is conducted after 30th April 2004; and

(b)immediately before 1st May 2004, a clinical trial certificate was in force and the trial was being conducted in accordance with that certificate.

(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 application for the clinical trial certificate.