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

• Citation: S.I. 1992/605
• Sections: 3

Section 1 Citation, commencement and interpretation

(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 ;

“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.

Section 2 Application of the Act to radiopharmaceutical-associated products

(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, 118, 119 and 125 of, and Schedule 3 to, the Act —

(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 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.

Section 3 Transitional provision

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.