Statutory Instrument 1991 No. 1474

The Medicines (Products for Human Use — Fees) Regulations 1991

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© Crown Copyright 1991

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1991 No. 1474

MEDICINES

The Medicines (Products for Human Use — Fees) Regulations 1991

The Secretary of State concerned with health in England, the Secretaries of State respectively concerned with health and with agriculture in Wales and in Scotland, 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, 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, those conferred by the said provisions and now vested in them^[2] and of all other powers enabling them in that behalf, after consulting such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations^[3], hereby make the following Regulations:

Citation, commencement and scope
    1.—(1)  These Regulations may be cited as the Medicines (Products for Human Use — Fees) Regulations 1991, and shall come into force on 18th July 1991.

    (2)  Subject to paragraph (3) below, these Regulations apply only to fees payable—
 (a) in connection with applications for the grant, variation or renewal of licences or certificates under Part II of the Medicines Act 1968^[4] relating wholly or partly to medicinal products for human use;
 (b) in respect of inspections made in connection with applications for the grant, variation or renewal of, or during the currency of any such licence;
 (c) in connection with the holding of such licences.

    (3)  No fee shall be payable under these Regulations in connection with any application for the grant, variation or renewal of a licence or certificate under Part II of the Act where that application is made at the specific written invitation of the licensing authority.

Interpretation
    2.—(1)  In these Regulations, unless the context requires otherwise—
"the Act" means the Medicines Act 1968 and, except as provided below, expressions used in these Regulations have the same meaning as in that Act;
"capital fee" means any fee, other than a periodic fee, payable under the provisions of these Regulations;
"licence fee period" means the period beginning with the coming into force of these Regulations and ending on 31st March 1992 and subsequently, the period beginning with the first day of April in any year and ending with the last day of March in the following year;
"medicinal product" includes any substance or article specified in any order made under section 104 or 105(1)(a) of the Act which directs that Part II of the Act shall have effect in relation to such substance or article;
"periodic fee" means a fee payable under regulation 14;
"product licence (parallel import)" means a product licence in respect of a medicinal product which is imported into the United Kingdom from another Member State of the European Economic Community, in respect of which there has been granted a marketing authorisation in another Member State of that Community and which has no differences having therapeutic effect from a medicinal product in respect of which a product licence has previously been granted in the United Kingdom;
"relevant licence fee period" means any licence fee period during any part of which a licence in respect of which a periodic fee is payable is in force.


    (2)  The interpretation provisions contained in Part I of Schedule 1 and Parts I and II of Schedule 3 shall have effect.

    (3)  In these Regulations any reference to a regulation or a Schedule shall be construed as a reference to a regulation contained in these Regulations, or as the case may be, to a Schedule thereto, and any reference in a regulation, Schedule or Part of a Schedule, to a numbered paragraph shall be construed as a reference to a paragraph of that regulation or, as the case may be, Schedule, or Part of a Schedule bearing that number.

Fees payable in connection with applications and inspections
    3.—(1)  Subject to paragraph (2), the amount of a capital fee payable in connection with an application is that payable in accordance with these Regulations as in force when the application is made.

    (2)  The amount of a fee payable in respect of an inspection is that payable in accordance with these Regulations as in force when the inspection is made.

[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 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). The expression "the Ministers" is defined in section 1(1) of the 1968 Act as so amended. back

[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). back

[3] See section 129(6) of the Medicines Act 1968 (c. 67) as extended to include regulations made under the Medicines Act 1971 by section 1(3)(b) of that latter Act. back

[4] 1968 c. 67. back

Explanatory Note