2. The Medicines Act 1968 M1 is 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/EEC of 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/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use”.
Marginal Citations