The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

Statutory Instruments

2007 No. 610

fees and charges

medicines

consumer protection

The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007

Made

1st March 2007

Laid before Parliament

7th March 2007

Coming into force

1st April 2007

The Secretary of State and the Department of Health, Social Services and Public Safety, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 1971(1) or, in the case of the Department, the powers conferred by those provisions and now vested in it(2).

In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on her by section 2(2) of the European Communities Act 1972(3) and section 56(1) and (2) of the Finance Act 1973(4). The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products(5) and medical devices(6).

The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973.

In accordance with section 129(6) of the Medicines Act 1968(7), the Secretary of State and the Department of Health, Social Services and Public Safety Development have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these 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); see therefore section 1(1) of the 1968 Act, as amended by Schedule 1 to S.I. 1969/388, by paragraph 1 of the Schedule to S.I. 1999/3142, by paragraph 15 of Schedule 1 to S.I. 2002/794 and by paragraph 2 of Schedule 8 to S.I. 2002/794, 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.

(2)

The powers vested in the Minister in charge of the Department 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 Department by virtue of section 1(8) of, and paragraph 4(1)(b) of the Schedule to, the Northern Ireland Act 2000 (c.1); the Department was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I. 1).

(3)

1972 c.68.

(4)

1973 c.51.

(5)

S.I. 1972/181.

(6)

The Secretary of State was designated in relation to measures relating to active implantable medical devices in S.I. 1991/2289, and in relation to measures relating to medical devices other than active implantable medical devices in S.I. 1993/2661.

(7)

1968 c.67; section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.