Medicines (Labelling) Amendment Regulations 1992
| Jurisdiction | UK Non-devolved |
| Citation | SI 1992/3273 |
| Year | 1992 |
1992 No. 3273
MEDICINES
The Medicines (Labelling) 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 concerned with health and agriculture in Wales and in Scotland respectively, 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 85(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 (Labelling) Amendment Regulations 1992, and shall come into force on 1st January 1993.
(2) In these Regulations “the principal Regulations” means the Medicines (Labelling) Regulations 19764.
Amendment of regulation 3(1) of the principal Regulations
2.—(1) Regulation 3(1) of the principal Regulations (interpretation) shall be amended in accordance with the following paragraphs of this regulation.
(2) After the definition of “business name” there shall be inserted the following—
““common name” in relation to a relevant medicinal product means the international non-proprietary name, or, if one does not exist, the usual common name;”.
(3) After the definition of “medicinal products of the same description” there shall be inserted the following—
““name” in relation to a relevant medicinal product means the name given to the product which may be either an invented name or a common or scientific name, together with a trade mark or the name of the person responsible for marketing the product;”.
(4) After the definition of “person responsible for the composition of a medicinal product” there shall be inserted the following—
““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;”.
(5) After the definition of “quantity” there shall be inserted the following—
““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;”.
(6) After the definition of “specified publication” there shall be inserted the following—
““strength” in relation to a relevant medicinal product means the content of active ingredient in that product expressed quantitatively per dosage unit, per unit volume or by weight, according to the dosage form;”.
Insertion of regulations 4A, 4B, 4C, 4D and 4E into the principal Regulations
3. After regulation 4 of the principal Regulations there shall be inserted the following regulations—
“Standard labelling requirements for containers and packages for medicinal products for human use
4A.—(1) Except where paragraph (2) or (3) of this regulation applies, containers and packages of relevant medicinal products shall be labelled to show the particulars set out in Schedule 7 to these regulations.
(2) Where the container of a relevant medicinal product is not a blister pack and is too small to be labelled to show all of the particulars set out in Schedule 7 to these regulations, it shall nevertheless be labelled to show the particulars set out in paragraphs 1, 4, 6, 9 and 15 of that Schedule.
(3) Where the container of a relevant medicinal product is a blister pack and is enclosed within a package which complies with paragraph (1) of this regulation, that container shall be labelled to show the particulars set out in paragraphs 1, 9, 12 and 15 of Schedule 7 to these regulations.
(4) Containers and packages of relevant medicinal products may be labelled to show—
(a)
(a) a symbol or pictogram designed to clarify the particulars set out in Schedule 7 to these regulations;
(b)
(b) other information compatible with the summary of product characteristics which is useful for health education,
to the exclusion of any element of a promotional nature.
(5) In sub-paragraph (b) of paragraph (4) of this regulation, “summary of product characteristics” means the information required to accompany any application for a product licence by virtue of Article 4a of Directive 65/65/EECwhich was inserted by Article 1(2) of Directive 83/570/EEC10and amended by Article 1(1) and (4) of Directive 89/341/EEC, which expression shall include, where there no such information accompanied the application—
(a)
(a) the data sheet, if there is one; or
(b)
(b) if there is no data sheet, the information which would be required to accompany an application for a product licence by virtue of Article 4a of Directive 65/65/EEC.
Standard labelling requirements for containers and packages of radiopharmaceuticals for human use
4B. Containers and packages of products to which Chapters II to V of the 1965 Directive applies which are radiopharmaceuticals shall be labelled to show the particulars set out in Schedule 8 to these regulations in addition to any particulars required by any other provision of these regulations.
General provisions relating to labelling of medicinal products for human use
4C.—(1) All labelling of containers and packages of relevant medicinal products shall be—
(a)
(a) legible and indelible;
(b)
(b) comprehensible; and
(b)
(b) either in the English language only or in English and in one or more other languages provided that the same particulars appear in all the languages used.
(2) Where the holder of a product licence for a...
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