The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000

Statutory Instruments

2000 No. 592

MEDICINES

FEES AND CHARGES

The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000

Made

6th March 2000

Laid before Parliament

7th March 2000

Coming into force

1st April 2000

The Secretary of State, being a Minister designated for the purposes of section 2(2) of the European Communities Act 1972(1) in relation to medicinal products(2), in exercise of the powers conferred upon him by the said section 2(2), 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(3), the Secretary of State concerned with health in England, the Minister of Agriculture, Fisheries and Food, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, 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(4), or, as the case may be, powers conferred by those provisions and now vested in them(5), and in each case in exercise of all other powers respectively enabling them in that behalf, after consultation in accordance with 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)

1972 c. 68.

(2)

S.I. 1972/1811.

(3)

1973 c. 51.

(4)

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 article 2(2) of, and Schedule 1 to, S.I. 1969/388 and by article 5 of, and the Schedule to, S.I. 1999/3142; see therefore section 1(1) of the 1968 Act, 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 the 1994 Regulations.

(5)

In the case of the Secretary of State concerned with health in England, by virtue of articles 2(1) and 5 of, and the Schedule to, S.I. 1999/3142; in the case of the Minister of Agriculture, Fisheries and Food, by virtue of articles 2(2) and 5 of, and the Schedule to, S.I. 1999/3142; in the case of the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, the powers vested in the Ministers in charge of those Departments by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c. 47) may now be exercised by the Departments by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c. 1).

(6)

1968 c. 67.