The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998

Statutory Instruments

1998 No. 574

MEDICINES FEES AND CHARGES

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998

Made

5th March 1998

Laid before Parliament

11th March 1998

Coming into force

1st April 1998

The Secretary of State concerned with health in England, the Secretaries of State concerned with health and agriculture in Wales and Scotland respectively, the Minister of Agriculture, Fisheries and Food, the Department of Health and Social Services for Northern Ireland and the Department of Agriculture for Northern Ireland, acting jointly and with the consent of the Treasury, in exercise of powers conferred upon them by section 1(1) and (2) of the Medicines Act 1971(1), or, as the case may be, powers conferred by those provisions and now vested in them(2), the Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972(3) in relation to medicinal products(4), in exercise of the powers conferred upon him by the said section 2(2), and the Secretary of State, with the consent of the Treasury, in exercise of the powers conferred upon him by section 56(1) and (2) of the Finance Act 1973(5), and in each case in exercise of all other powers respectively enabling them in that behalf, after consultation (in so far as is required by section 129(6) of the Medicines Act 1968(6), as extended by section 1(3)(b) of the Medicines Act 1971) with such organisations as appear to them to be representative of interests likely to be substantially affected, hereby make the following Regulations:—

(1)

1971 c. 69; as amended by section 21 of the Health and Medicines Act 1988 (c. 49). By virtue of section 1(3) of the 1971 Act expressions used in that section have the same meaning as in the Medicines Act 1968 (c. 67) as amended by the Transfer of Functions (Wales) Order 1969 (S.I. 1969/388); see therefore section 1(1) of the 1968 Act, as so amended, which contains a definition of “the Ministers” which is relevant to the powers being exercised in the making of these Regulations. See also regulation 9(12) of the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I. 1994/3144) by virtue of which the references in section 1(1) and (2)(b) of the 1971 Act to a licence under Part II of the 1968 Act include reference to a marketing authorization under those Regulations.

(2)

In the case of the Secretaries of State concerned with health in England and in Wales, by virtue of article 2(2) of and Schedule 1 to the Transfer of Functions (Wales) Order 1969; in the case of the Secretary of State concerned with agriculture in Wales, by virtue of article 2(3) of and Schedule 1 to the Transfer of Functions (Wales) (No. 1) Order 1978 (S.I. 1978/272); in the case of the Northern Ireland Departments, by virtue of section 40 of and Schedule 5 to the Northern Ireland Constitution Act 1973 (c. 36) and section 1(3) of and paragraph 2(1)(b) of Schedule 1 to the Northern Ireland Act 1974 (c. 28).

(3)

1972 c. 68.

(4)

S.I. 1972/1811.

(5)

1973 c. 51.

(6)

1968 c. 67.