The Medicines for Human Use (Clinical Trials) Regulations 2004

Applications for clinical trial exemptions or notifications prior to 1st May 2004

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

(a) an application for a clinical trial certificate has been made in accordance with section 36 of the Act and the licensing authority has not before 1st May 2004 determined whether to issue a certificate;

(b) the licensing authority has received a notice pursuant to article 4(1)(a) of the Medicines (Exemption from Licences) (Clinical Trials) Order 1995 and on 1st May 2004—

(i) the specified period within the meaning of article 4(2) of that Order has not expired, and

(ii) the authority has not given or sent a notice pursuant to article 4(1)(b); or

(c) the licensing authority has received a notice pursuant to article 4(2)(iv) of the Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 and on 1st May 2004—

(i) the period specified in article (2)(v) of that Order has not expired, and

(ii) the authority has not given a direction pursuant to that article.

(2) Where sub-paragraph (1) applies the licensing authority shall treat the application or notice as a valid request for authorisation to conduct the clinical trial to which the application or notice relates under regulation 17.