1.—(1) These Regulations may be cited as the Medicines (Products for Human Use) (Fees) Regulations 2013.
(2) Unless paragraph (3) applies these Regulations shall come into force on 1st April 2013.
(3) The following regulations shall come into force on the coming into force of Regulations made under section 2(2) of the European Communities Act 1972 to implement provisions related to importers, manufacturer’s and distributors of active substances as provided for by Article 52a and persons brokering medicinal products as provided for by Article 85b of Directive 2001/83/EC(1)—
(a)12(1), insofar as it relates to a broker’s registration or an active substance registration;
(b)18(1)(c);
(c)20;
(d)21;
(e)29(1)(a), insofar as it relates to a broker’s registration or an active substance registration;
(f)36;
(g)37(7), insofar as it relates to a broker’s registration or an active substance registration;
(h)40(1), insofar as it relates to a broker’s registration or an active substance registration and (2)(c);
(i)48(2)(e);
(j)Schedule 2, paragraphs 32, 33, 46 and 47;
(k)Schedule 3, paragraphs 8 and 9;
(l)Schedule 7, paragraph 6 insofar as it relates to a broker’s registration or an active substance registration.
2. These Regulations shall be interpreted in accordance with Schedule 1.
OJ No L 311, 28.11.2001, p67. Articles 52a and 85b were inserted into Directive 2001/83/EC by Article 1(10) and (19) of Directive 2011/62/EU of the European Parliament and of the Council (OJ No L 174, 1.7.2011, p74) and are expected to be implemented shortly after the commencement of these Regulations.