The Health and Personal Social Services(Northern Ireland) Order 1991

The Medicines Act 1968 (c. 67)

5.—(1) In any case where—

(a) before the appointed day, a health and social services body or an HSS trust has made an application for a licence under Part II of the Medicines Act 1968 or any such application as is referred to in section 36 of that Act (applications for clinical trial and animal test certificates), and

(b) the application was accompanied by a declaration under head (a) or head (b) of sub-paragraph (2), and

(c) the application has not been determined before the appointed day, then, on and after the appointed day and until the application is determined, the health and social services body or HSS trust concerned shall be treated for all purposes as if it held a licence or, as the case may be, a certificate of the description applied for.

(2) The declarations referred to in sub-paragraph (1)(b) are,—

(a) in the case of a health and social services body, that, at the date of the application, the body was carrying on activities which, after the appointed day, it would be unlawful to carry on except in accordance with a licence or certificate of the description applied for; and

(b) in the case of an HSS trust, that the trust has been established to assume responsibility for the ownership and management of a hospital or other establishment or facility and, at the date of the application, a health and social services body was carrying on at that hospital, establishment or facility activities which it is unlawful for the HSS trust to carry on except in accordance with a licence or certificate of the description applied for.

(3) For the purposes of sub-paragraph (1), an application is determined when the licensing authority—

(a) grant a licence or, as the case may be, certificate to the applicant (whether or not in accordance with the application); or

(b) notify the applicant of their refusal to grant a licence or certificate on the application.

(4) Expressions used in sub-paragraphs (1) to (3) have the same meaning as in sections 18 to 22 of the Medicines Act 1968 (applications for, and grant of, licences), including, where applicable, any of those sections as applied by subsection (3) of section 36 of that Act in relation to applications falling within subsection (1) of that section.