The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007

This Statutory Instrument has been made in consequence of a defect in SI 2007/610 and is being issued free of charge to all known recipients of that Statutory Instrument.

Statutory Instruments

2007 No. 803

fees and charges

medicines

consumer protection

The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007

Made

12th March 2007

Laid before Parliament

16th March 2007

Coming into force

for the purpose of regulation 14

13th March 2007

for all other purposes

1st April 2007

The Secretary of State for Health, the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, 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, as the case may be, the powers conferred by those provisions and now vested in them(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 for Health, the Department of Health, Social Services and Public Safety Development and the Department of Agriculture and Rural 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) as amended by S.I. 1969/388; see therefore section 1(1) of the 1968 Act, as amended by Schedule 1 to S.I. 1969/388, 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)

In the case of the Secretary of State, by virtue of article 2(1) of S.I. 1999/3142 and article 3(1)(c) and (7) of S.I. 2002/794. In the case of the Department of Health, Social Services and Public Safety and the Department of Agriculture and Rural Development, by virtue of 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), which 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 Departments were renamed by virtue of Article 3(4) and (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.