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Article 2

SCHEDULE 1FUNCTIONS THE COSTS OF WHICH ARE TO BE TAKEN INTO ACCOUNT IN FIXING FEES UNDER THE 1971 ACT

1.  Functions of the Ministers under Parts I, II, III, V, VI and, subject to paragraph 11 below, VIII of the 1968 Act and under the 1971 Act.

2.  Functions of the Licensing Authority under Part II of the 1968 Act.

3.  Functions (except those under Part VII of the 1968 Act) of the Medicines Commission established under section 2 of the 1968 Act.

4.  Functions of the following Committees established under section 4 of the 1968 Act: the Committee on Safety of Medicines, the Committee on Review of Medicines and the Committee on Dental and Surgical Materials.

5.  Functions of the Ministers or the Licensing Authority in relation to anything done by the European Communities or any of their institutions with respect to the control of medicinal products.

6.  Functions of the Ministers or the Licensing Authority in relation to anything done by the World Health Organisation with respect to the control of medicinal products.

7.  Without prejudice to paragraphs 5 and 6, functions of the Ministers or the Licensing Authority arising under any international instrument relating to the control of medicinal products.

8.  Functions of persons appointed under the 1968 Act.

9.  Functions of the Medicines Testing Laboratory of the Royal Pharmaceutical Society of Great Britain under arrangements made with Ministers in respect of work relating to enforcement of the 1968 Act.

10.  Without prejudice to the generality of the foregoing paragraphs, the following functions of the Ministers:–

(a)review of the functioning of the laws relating to the control of medicinal products (including whether or not a product or class of articles or substances should be made subject to such control) and development of proposals for legislation relating thereto;

(b)maintenance of relations with persons and organisations both within the United Kingdom and abroad in respect of matters relating to the control of medicinal products;

(c)subject to paragraph 11 below, enforcement of the 1968 Act and regulations and orders made under it, including investigation and prosecution of offences thereunder;

(d)the conduct of civil proceedings for the recovery of debt arising in relation to any of the functions otherwise specified in this Schedule.

11.  Paragraphs 1 and 10(c) above do not apply to the function of Ministers under the 1968 Act to enforce that Act and regulations and orders made under it in so far as that function consists of the enforcement of provisions relating to the retail sale, or supply in circumstances corresponding to retail sale, of medicinal products.