Statutory Instrument 1992 No. 605

The Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992

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© Crown Copyright 1992

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1992 No. 605

MEDICINES

The Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992

The Secretary of State in exercise of powers conferred by section 2(2) of the European Communities Act 1972^[1], being designated for the purposes of section 2(2) of that Act in respect of radioactive substances and the emission of ionising radiations^[2] hereby makes the following regulations:

Citation, commencement and interpretation
    1.    —(1)  These Regulations may be cited as the Medicines Act 1968 (Application to Radiopharmaceutical-associated Products) Regulations 1992 and shall come into force—
 (a) for the purpose of making Regulations under section 18 of the Act (including that section as applied by section 24(4) of the Act), on 11th March 1992; and
 (b) for all other purposes, on 3rd April 1992.

    (2)  In these Regulations, unless the context requires otherwise—

"the Act" means the Medicines Act 1968^[3];


"generator" means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and is to be used in a radiopharmaceutical;


"kit" means any preparation to be reconstituted or combined with radionuclides in a final radiopharmaceutical, usually prior to its administration;


"precursor" means a radionuclide produced for the radio-labelling of another substance prior to administration, other than a radionuclide which is incorporated in, or produced from, a generator, or is included in a radiopharmaceutical;


"radiopharmaceutical" means any medicinal product which, when ready for use, contains one or more radionuclides included for a medicinal purpose;


"radiopharmaceutical-associated product" means a generator, kit or precursor which is not itself a medicinal product;

and any other expression used in these Regulations which is defined in the Act shall, unless the context requires otherwise, bear the meaning which it bears in the Act.

Application of the Act to radiopharmaceutical-associated products
    2.—(1)  Subject to paragraph (2) of this regulation, the provisions of the Act specified in column 1 of the Schedule to these Regulations shall have effect in relation to radiopharmaceutical-associated products as they have effect in relation to medicinal products.

    (2)  Where in relation to any provision specified in column 1 of the Schedule to these Regulations there is an entry in column 2 of that Schedule, that provision shall, in its application to radiopharmaceutical-associated products, have effect subject to the modification specified in that entry.

    (3)  For the purposes of Part I, sections 108 to 115,^[4] 118, 119 and 125^[5] of, and Schedule 3 to, the Act^[6]}N
 (a) the provisions of the Act applied by paragraphs (1) and (2) of this regulation to radiopharmaceutical-asociated products, and the provisions of any regulations made under any of those provisions as so applied, shall be treated as provisions of, respectively, the Act and regulations made under it;
 (b) any offence against any of those provisions shall be treated as an offence under the Act; and
 (c) any reference in any of those provisions to medicinal products shall be treated as including a reference to radiopharmaceutical-associated products.

    (4)  The provisions of sections 1 and 132^[7] of the Act (definitions) shall have effect in relation to radiopharmaceutical-associated products in so far as they relate to the provisions of the Act specified in column 1 of Schedule 1 to these Regulations.

Transitional provision
    3.    These Regulations shall not render unlawful anything done before 31st December 1992 in relation to a radiopharmaceutical-associated product if—
 (a) products of that description were sold or supplied, or procured to be sold, supplied, manufactured or assembled, at any time before 3rd April 1992; and
 (b) products of that description were effectively on the market in the United Kingdom immediately before 3rd April 1992.

Signed by authority of the Secretary of State for Health.

Virginia Bottomley

Minister of State, Department of Health

9th March 1992

[1] 1972 c. 68. back

[2] S.I. 1977/1718. back

[3] 1968 c. 67. back

[4] Sections 108 and 109 have been amended. Relevant amendments have been made by Schedule 3 to the Food Safety Act 1990 (c. 16). Section 110 has been amended by S.R. & O. (N.I.) 1973/211. Section 114 has been amended. Criminal penalties under the 1968 Act have been increased. Fines on summary conviction of offences triable either way under statutes passed before, or in the same Session as the Criminal Law Act 1977 (c. 45) were standardised in England and Wales by section 28 of the Criminal Law Act 1977, in Scotland by section 289B of the Criminal Procedure (Scotland) Act 1975 (c. 21), and in Northern Ireland by article 6 of the Fines and Penalties etc. (Northern Ireland) Order 1984 (S.I. 1984/703). "The statutory maximum" and "the prescribed sum" are now both £2000. Levels on the standard scale are presently fixed by the Criminal Penalties etc. (Increase) Order 1984 (E & W) (S.I. 1984/447), the Increase of Criminal Penalties etc. (Scotland) Order 1984 (S.) (S.I. 1984/526) and by the Criminal Penalties etc. (Increase) Order (Northern Ireland) 1984 (S.R. 1984/253). These instruments respectively amend section 37(2) and section 74 of the Criminal Justice Act 1982 (c. 48), sections 289B(6) and 289G(2) of the Criminal Procedure (Scotland) Act 1975 and articles 4 and 5 of the Fines and Penalties etc. (Northern Ireland) Order 1984. Section 289B was inserted by paragraph 5 of Schedule 11 to the Criminal Law Act 1977, and section 289G by section 54 of the Criminal Justice Act 1982. back

[5] Section 125(1) has been amended by Schedule 7 to the Magistrates Courts Act 1980 (c. 43), subsection (2) has been amended by section 460(1)(b) of the Criminal Procedure (Scotland) Act 1975 and subsection (6) by S.R. & O (N.I.) 1973/211. back

[6] Schedule 3 has been amended by S.I. 1968/1699, S.R. & O (N.I.) 1973/211, the Food Act 1984 (c. 30), S.I. 1989/846, the Food Safety Act 1990 (c. 16) and S.I. 1991/762. back

[7] Section 132 has been amended. Relevant amendments have been made by Schedule 3 to the Food Safety Act 1990. back

Explanatory Note