Regulation 2 Amendment of regulation 2(1) of the principal Regulations

Regulation 2(1) of the principal Regulations (interpretation) shall be amended in accordance with the following paragraphs of this regulation.

After the definition of “medicinal product” there shall be inserted the following—

““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;

“product to which Chapters II to V of the 1965 Directive applies” means a medicinal product to which, in accordance with Article 2 of Council directive 65/65/EEC as amended^f1, Article 34 of Council Directive 75/319/EEC^f2, Article 1 of Council Directive 89/342/EEC^f3, Article 1 of Council Directive 89/343/EEC^f4 and Article 1 of Council Directive 89/381/EEC^f5, Chapters II to V of Council Directive 65/65/EEC apply;”.

For the definition of “proprietary medicinal product” shall be substituted the following—

““proprietary medicinal product” means a ready-prepared medicinal product placed on the market in the United Kingdom under a special name and in a special pack, but does not include a homeopathic medicinal product or veterinary drug and references to a proprietary medicinal product shall be taken to include a reference to a radiopharmaceutical-associated product;”.

After that definition of “proprietary medicinal product” there shall be inserted the following—

““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;

“relevant medicinal product” means a product to which Chapters II to V of the 1965 Directive applies in respect of which a product licence is granted or renewed on or after 1st January 1994;

“summary of product characteristics” means the information required to accompany any application for a product licence by virtue of article 4a of Council Directive 65/65/EEC which was inserted by article 1(2) of Council Directive 83/570/EEC^f6 as amended by article 1(1) and (4) of Council Directive 89/341/EEC.”.