Medicines (Leaflets) Amendment Regulations 1992
| Jurisdiction | UK Non-devolved |
| Citation | SI 1992/3274 |
| Year | 1992 |
1992 No. 3274
MEDICINES
The Medicines (Leaflets) Amendment Regulations 1992
Made 22th December 1992
Laid before Parliament 23th December 1992
Coming into force 1st January 1993
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, in exercise of powers conferred upon them by sections 86(1) and 91(3) of the Medicines Act 19681or, as the case may be, those conferred by the said provisions and now vested in them2and 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 Regulations3, hereby make the following Regulations:
Citation, commencement and interpretation
1.—(1) These Regulations may be cited as the Medicines (Leaflets) Amendment Regulations 1992, and shall come into force on 1st January 1993.
(2) In these Regulations, “the principal Regulations” means the Medicines (Leaflets) Regulations 19774.
Amendment of regulation 2(1) of the principal Regulations
2.—(1) Regulation 2(1) of the principal Regulations (interpretation) shall be amended in accordance with the following paragraphs of this regulation.
(2) 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/EECas amended5, Article 34 of Council Directive 75/319/EEC6, Article 1 of Council Directive 89/342/EEC7, Article 1 of Council Directive 89/343/EEC8and Article 1 of Council Directive 89/381/EEC9, Chapters II to V of Council Directive 65/65/EECapply;”.
(3) 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;”.
(4) 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/EECwhich was inserted by article 1(2) of Council Directive 83/570/EEC10as amended by article 1(1) and (4) of Council Directive 89/341/EEC.”.
Amendment of regulation 3 of the principal Regulations
3. For regulation 3 of the principal Regulations (standard requirements relating to leaflets) there shall be substituted the following regulation—
“3.—(1) Subject to the following provisions of these regulations, all leaflets included in the package or container of any proprietary medicinal products other than relevant medicinal products shall contain the particulars set out in Schedule 1 to these regulations.
(2) Subject to the following provisions of these regulations, all leaflets included in the package or container of any relevant medicinal products shall contain the particulars set out in Schedule 2 to these regulations in the order shown in that Schedule.”.
Insertion of regulation 3A into the principal Regulations
4. After regulation 3 of the principal Regulations (standard requirements relating to leaflets), there shall be inserted the following regulation—
“Standard requirements relating to leaflets for radiopharmaceuticals and radiopharmaceutical-associated products
3A. Subject to the following provisions of these regulations, any leaflet which is enclosed with the packaging of a proprietary medicinal product which is a radiopharmaceutical or a radiopharmaceutical-associated product shall, in addition to containing any particulars required by any other provision of these regulations, contain—
(a) details of any precautions to be taken by the user and the patient during the preparation and administration of the product;
(b) details of any special precautions to be taken in respect of the disposal of the container and its unused contents.”.
Amendment of regulation 4 of the principal Regulations
5.—(1) Regulation 4 of the principal Regulations (general provisions) shall be amended in accordance with the following paragraphs of this regulation.
(2) In paragraph (1), for the words “such a leaflet” there shall be substituted “a leaflet relating to a proprietary medicinal product other than a relevant medicinal product”.
(3) After paragraph (1) there shall be inserted the following—
“1A All particulars contained in such a leaflet as is described in regulation 3 above relating to a relevant medicinal product shall be drawn up in accordance—
(a) with the summary of product characteristics, if there is one;
(b) if there is no summary of product characteristics, with the data sheet, if there is one;
(c) if there is no summary of product characteristics and no data sheet, with the information which would be required to accompany an application for a product licence by virtue of Article 4a of Council Directive 65/65/EEC.”.
(4) In paragraph (2)—
(a)
(a) the word “such” shall be omitted;
(b)
(b) after the word “shall” shall be inserted the words “be written in clear and...
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