16. The Medicines (Products for Human Use—Fees) Regulations 1995(1) are amended as follows—
(a)in regulation 2(1) (interpretation)—
(i)in the definition of “concerned member State” for “Chapter III of Directive 75/319/EEC” there is substituted “Title III, Chapter 4 of the 2001 Directive”,
(ii)for the definition of “Directive 75/319/EEC” there is substituted 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;”,
(iii)in the definition of “medicinal product” for “Chapters II to V of Council Directive 65/65/EEC apply” there is substituted “the 2001 Directive applies”, and
(iv)for the definition of “Periodic Safety Update Report” there is substituted the following definition—
““Periodic Safety Update Report” means a report prepared to meet the requirements of the 2001 Directive and in accordance with the International Conference on Harmonisation and Committee on Proprietary Medicinal Products Guidance on clinical safety data management—Periodic Safety Update Reports for marketing drugs;”;
(b)in regulation 6A (meaning of “set of applications”)—
(i)for “Chapter III of Directive 75/319/EEC” there is substituted “Title III, Chapter 4 of the 2001 Directive”, and
(ii)for “article 9.4 of Council Directive 75/319/EEC”, in both places where those words occur, there is substituted “Article 28.4 of the 2001 Directive”;
(c)in regulation 6B (application for regulatory assistance under the mutual recognition procedure) for “Chapter III of Directive 75/319/EEC” there is substituted “Title III, Chapter 4 of the 2001 Directive”;
(d)in regulation 6C (time for payment of fees under regulation 4B) for “article 9.3 of Directive 75/319” there is substituted “Article 28.1 of the 2001 Directive”;
(e)in Schedule 1, Part 1, paragraph 1 (interpretation)—
(i)in head (b) of the definition of “decentralised incoming application” for “Chapter III of Directive 75/319/EEC” there is substituted “Title III, Chapter 4 of the 2001 Directive”, and
(ii)in head (a) of the definition of “simple application” for “Article 4.8(a)(i) of Council Directive 65/65/EEC” there is substituted “Article 10.1(a)(i) of the 2001 Directive”;
(f)in Schedule 1, Part II, paragraph 1(1) (capital fees for marketing authorizations), in column 1 of the Table, entry 1 (major application) in head (a) for “Part 4 of the Annex to Council Directive 75/318/EEC” there is substituted “Part 4 of Annex I to the 2001 Directive”;
(g)in Schedule 1, Part IIA, paragraph 2 (outgoing mutual recognition applications) for “Chapter III of Directive 75/319/EEC” there is substituted “Title III, Chapter 4 of the 2001 Directive”;
(h)in Schedule 1, Part III (capital fees for applications for variations)—
(i)in paragraph 1, in head (b)(ii) of the definition of “Type II Complex Variation Application” for “Section H of Part IV of Annex to Council Directive 75/318/EEC” there is substituted “Section H of Part IV of Annex I to the 2001 Directive”, and
(ii)in paragraphs 4 and 5 for “Section G of Part 4 of the Annex to Council Directive 75/318/EEC”, in each place where those words occur, there is substituted “Section G of Part 4 of Annex I to the 2001 Directive”;
(i)in Schedule 3, Part 1, paragraph 1 (periodic fees for licences—interpretation) in the definition of “limited use drug” for “Section G of Part 4 of the Annex to Council Directive 75/318/EEC” there is substituted “Section G of Part 4 of Annex I to the 2001 Directive”;
(j)in Schedule 3, Part IV (types of marketing authorization for which only one periodic fee is payable), in paragraph 1 for “Council Directive 65/65/EEC” there is substituted “the 2001 Directive”;
(k)in Schedule 4 (time for payment of capital fees—applications made by small companies), in paragraph 4A, sub-paragraphs (a)(i) and (b)(i) for “article 9.3 of Directive 75/319”, in each place where those words occur, there is substituted “Article 28.1 of the 2001 Directive”; and
(l)in Schedule 5 (waiver, reduction or refund of capital fees), in paragraph 6 for “Council Directive 65/65/EEC” there is substituted “the 2001 Directive”.