The Medicines (Codification Amendments Etc.) Regulations 2002

Amendment of the Product Licences Regulations 1993

7.  The Medicines (Applications for Grant of Product Licences—Products for Human Use) Regulations 1993(1) are 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/EC of 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 occur, there is substituted “that Directive”, and

(iii) in regulation 4(2) for “those Chapters applied” there is substituted “that Directive applies”;

(c) regulation 4(7) (requirements for applications before 1st January 1995) is deleted;

(d) in Schedule 1 (information and documents etc. required for applications)—

(i) in paragraph 9(d)(v) for “Directive 89/342/EEC applies” there is substituted “the 2001 Directive applies”,

(ii) in paragraph 9(g) for “Directive 89/343/EEC” there is substituted “the 2001 Directive”,

(iii) in paragraph 10 for “Article 16 of Directive 75/319/EEC” there is substituted “Article 40 of the 2001 Directive”,

(iv) in paragraph 11 for “Article 4a of the 1965 Directive” there is substituted “Article 11 of the 2001 Directive”,

(v) in paragraphs 17 and 18 for “Annex to Directive 75/318/EEC”, in each place where those words occur, there is substituted “Annex I to the 2001 Directive”,

(vi) in paragraph 21 for “Article 3 of Directive 89/343/EEC” there is substituted “Article 9 of the 2001 Directive”, and

(vii) in paragraph 22(b) for “Directive 89/343/EEC” there is substituted “the 2001 Directive”; and

(e) in Schedule 2 (exceptions to the requirement to provide particulars of certain tests' and trials' results), in paragraph 1(b) for “the second paragraph of Article 1 of Directive 75/318/EEC” there is substituted “Article 10.2 of the 2001 Directive”.

(1)

S.I. 1993/2538; a relevant amendment was made by S.I. 1997/654.