Medicines (Codification Amendments Etc.) Regulations 2002
| Year | 2002 |
2002 No. 236
MEDICINES
The Medicines (Codification Amendments Etc.) Regulations 2002
Made 7th February 2002
Laid before Parliament 7th February 2002
Coming into force 28th February 2002
The Secretary of State, in exercise of the powers conferred by section 2(2) of the European Communities Act 19721, being designated for the purposes of that section in relation to medicinal products2, hereby makes the following Regulations—
Citation, commencement and interpretation
1.—(1) These Regulations may be cited as the Medicines (Codification Amendments Etc.) Regulations 2002 and shall come into force on 28th February 2002.
(2) In these Regulations “the 2001 Directive” means Directive 2001/83/ECof the European Parliament and of the Council on the Community code relating to medicinal products for human use3.
Amendment of the Medicines Act 1968
2. The Medicines Act 19684is amended as follows—
(a) in the following sections for “Chapters II to V of the 1965 Directive apply”, in each place where those words occur, there is substituted “the 2001 Directive applies”—
(i) section 8(3A) and (3C) (manufacture and wholesale dealing),
(ii) section 14(2) (exports to a Member State),
(iii) section 28(3)(j) and (3A) (general power to suspend, revoke or vary licences),
(iv) section 49A(a) (exporting certain products to Member States),
(v) section 58A(1)(b) (specification of prescription-only products), and
(vi) section 86(4) (leaflets);
(b) in section 18(3) (application for licence) for “Article 9 of the Second Council Directive 75/319/EECof 20 May 1975” there is substituted “Article 28 of the 2001 Directive”;
(c) in section 24 (duration and renewal of licence)—
(i) in subsection (1A) for “the 1992 Directive” there is substituted “Title V of the 2001 Directive”,
(ii) in subsection (3)(C) for “the 1965 Directive or the 1992 Directive” there is substituted “the 2001 Directive other than Titles VI, VII and VIII of that Directive”, and
(iii) subsection (7) is deleted;
(d) in section 132 (general interpretation provisions)—
(i) the definition of “the 1965 Directive” is deleted, and
(ii) after the definition of “the 1981 Directive” there is inserted the following definition—
““the 2001 Directive” means Directive 2001/83/ECof the European Parliament and of the Council on the Community code relating to medicinal products for human use”.
Amendment of the Standard Provisions Regulations 1971
3. The Medicines (Standard Provisions for Licences and Certificates) Regulations 19715are amended as follows—
(a) in regulation 2(1) (interpretation)—
(i) after the definition of ““clinical trial certificate of right” and “animal test certificate of right”” there is inserted the following definition—
““the 2001 Directive” means Directive 2001/83/ECof the European Parliament and of the Council on the Community code relating to medicines for human use;”,
(ii) in the definition of “exempt imported products” for “article 1(2) of Council Directive 65/65/EEC” there is substituted “Article 1.2 of the 2001 Directive”,
(iii) for the definition of “product to which Chapters II to V of the 1965 Directive apply” there is substituted the following definition—
““product to which the provisions of the 2001 Directive apply” means a medicinal product to which, in accordance with Article 2 of the 2001 Directive, the provisions of that Directive apply and accordingly does not include the products mentioned in Article 3 of that Directive;”, and
(iv) the definition of “Second Council Directive” is omitted;
(b) in Schedule 1 (standard provisions for product licences), in paragraph 16 for “Part 4G of the Annex to Council Directive 75/318/EEC” there is substituted “Part 4G of Annex I to the 2001 Directive”;
(c) in Schedule 2 (standard provisions for manufacturer’s licences), in paragraph 16(1) and (4) for “Articles 23 and 24 of the Second Council Directive”, in each place where those words occur, there is substituted “Articles 49 and 50 of the 2001 Directive”;
(d) in Schedule 3 (standard provisions for wholesale dealer’s licences)—
(i) in paragraphs 4A, 4B(1), 7A(1), 7B and 7C(1) for “Chapters II to V of the 1965 Directive”, in each place where those words occur, there is substituted “the provisions of the 2001 Directive”,
(ii) in paragraphs 7(3)(a), 8(1) and (6) for “Articles 23 and 24 of the Second Council Directive”, in each place where those words occur, there is substituted “Articles 49 and 50 of the 2001 Directive”, and
(iii) in paragraph 8(1) for “Article 24” there is substituted “Article 50”; and
(e) in Schedule 5, Part I (standard provisions for product licences for medicinal products to which regulation 5 of the Standard Provisions Regulations applies), in paragraph 3A for “Council Directive 65/65/EECas amended” there is substituted “the 2001 Directive”.
Amendment of the Manufacturer’s and Wholesaler Dealer’s Regulations 1971
4. The Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 19716are amended as follows—
(a) in regulation 2(1) (interpretation)—
(i) after the definition of “application” there is inserted the following definition—
““the 2001 Directive” means Directive 2001/83/ECof the European Parliament and of the Council on the Community code relating to medicinal products for human use;”, and
(ii) for the definition of “product to which Chapters II to V of the 1965 Directive apply” there is substituted the following definition—
““product to which the provisions of the 2001 Directive apply” means a medicinal product to which, in accordance with Article 2 of the 2001 Directive, the provisions of that Directive apply and accordingly does not include the products mentioned in Article 3 of that Directive;”; and
(b) in Schedule 2 (particulars required on a wholesale dealer’s licence application), in paragraphs 8A, 8B and 8C for “Chapters II to V of the 1965 Directive apply”, in each place where those words occur, there is substituted “the 2001 Directive applies”.
Amendment of the Labelling Regulations 1976
5. The Medicines (Labelling) Regulations 19767are amended as follows—
(a) in regulation 3(1) (interpretation)—
(i) after the definition of “data sheet” there is inserted the following definition—
““the 2001 Directive” means Directive 2001/83/ECof the European Parliament and of the Council on the Community code relating to medicinal products for human use;”,
(ii) for the definition of “homoeopathic product to which Council Directive 92/73/EECapplies” there is substituted—
““homoeopathic product to which the 2001 Directive applies” means a medicinal product for human use (which may contain a number of principles) prepared from products, substances or compositions called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State, other than one—
(i) prepared in accordance with a magistral or officinal formula as described in Article 3(1) and (2) of the 2001 Directive, or
(ii) which satisfies the criteria laid down in Article 5 of the 2001 Directive;”,
(iii) the definition of “product to which Chapters II to V of the 1965 Directive applies” is deleted, and
(iv) in the definition of “relevant medicinal product” for “Chapters II to V of the 1965 Directive” there is substituted “the 2001 Directive”;
(b) in regulation 4A (standard labelling requirement), in paragraph (5)—
(i) for the words from “Article 4a of Directive 65/65/EEC” to “Directive 89/341/EEC” inclusive there is substituted “Article 11.1 to 11.7 of the 2001 Directive”, and
(ii) in sub-paragraph (b), for “Article 4a of Directive 65/65/EEC” there is substituted “Article 11.1 to 11.7 of the 2001 Directive”;
(c) in regulation 4B (standard labelling requirements for radiopharmaceuticals) for “Chapters II to V of the 1965 Directive” there is substituted “the 2001 Directive”; and
(d) in regulation 4F (standard labelling requirements for certain homoeopathic products), in paragraph (1) for “Council Directive 92/73/EEC” there is substituted “the 2001 Directive”.
Amendment of the Active Implantable Medical Devices Regulations 1992
6. Paragraph 10 of Schedule 2 to the Active Implantable Medical Devices Regulations 19928(essential requirements for active implantable medical devices), is amended as follows—
(a) for “Article 1 of Directive 65/65/EEC” there is substituted “Article 1 of Directive 2001/83/ECon the European Parliament and of the Council on the Community code relating to medicinal products for human use”; and
(b) for the words “Directive 75/318/EEC, as last amended by Directive 91/507/EEC” there is substituted “that Directive”.
Amendment of the Product Licences Regulations 1993
7. The Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 19939are amended as follows—
(a) in regulation 1(2) (interpretation)—
(i) after the definition of “application” there is inserted the following definition—
““the 2001 Directive” means Directive 2001/83/ECof the European Parliament and of the Council on the Community code relating to medicinal products for human use;”, and
(ii) in the definition of “the Directives” after “ 89/381/EEC” there is inserted “notwithstanding their repeal by the 2001 Directive”;
(b) in regulation 4(1) and (2) (material in application)—
(i) for “Chapters II to V of the 1965 Directive apply”, in each place where those words occur, there is substituted “the 2001 Directive applies”,
(ii) for “the Directives”, in each place where those words...
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