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Statutory Instrument 1989 No. 418

The Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989

(The document as of February, 2008)

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STATUTORY INSTRUMENTS

1989 No. 418

MEDICINES

The Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989

Made9th March 1989
Laid before Parliament10th March 1989
Coming into force1st April 1989

    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 the powers conferred by section 1(1) and (2) of the Medicines Act 1971[1] 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:-


PART I

GENERAL
    Citation, commencement and scope
        1.—(1)  These Regulations may be cited as the Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989 and shall come into force on 1st April 1989.

        (2)  Subject to paragraphs (3) and (4) 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 relating wholly or partly to medicinal products for human use; or
       (b) in respect of inspections made in connection with applications for the grant, renewal or variation of, or during the currency of any such licence or certificate.

        (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 Medicines Act 1968 by an authority constituted under the National Health Service Act 1977[4], the National Health Service (Scotland) Act 1978[5] or the Health and Personal Social Services (Northern Ireland) Order 1972[6] or in respect of any inspection made in connection with such an application or during the currency of a licence or certificate held by such an authority.

        (4)  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 Medicines Act 1968 where that application is made at the specific written invitation of the licensing authority.
    Interpretation
        2.—(1)  Except as provided in paragraph (2) below, expressions used in these Regulations have the same meaning as in the Medicines Act 1968.

        (2)  In these Regulations, "medicinal product" includes any substance or article specified in any order made under section 104 or 105(1)(a) of the Medicines Act 1968 which directs that Part II of that Act shall have effect in relation to such substance or article.


Notes:

[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.

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

[4] 1977 c. 49.

[5] 1978 c. 29.

[6] S.I. 1972/1265 (N.I.14).

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