Medicines Act 1968

59 Special provisions in relation to new medicinal products. U.K.

(1) The following provisions of this section shall have effect where an order under section 58 of this Act is made so as to apply to all medicinal products which fall within a class specified in the order and are of a description in respect of which the following conditions are fulfilled, that is to say, that—

(a) medicinal products of that description were not effectively on the market in the United Kingdom immediately before the first appointed day;

(b) a product licence granted under Part II of this Act (whether before, on or after the date on which the order comes into operation) applies to medicinal products of that description (whether it also applies to medicinal products of any other description or not); and

(c) before the grant of that licence, no product licence had been granted which was applicable to medicinal products of that description.

(2) Where such an order is made in accordance with the preceding subsection—

(a) the restrictions imposed by section 58(2) of this Act shall not apply by virtue of the order to medicinal products of any description except during a period beginning with the date which, in relation to medicinal products of that description, is the relevant date and of such duration from that date as may be specified in the order;

(b) in section 58(4)(a) of this Act the reference to exemptions specified in the order shall, in relation to that order, be construed as including a reference to any exemption specified in a direction given by the F1 ... Ministers and relating to medicinal products of a particular description specified in that direction.

(3) In subsection (2)(a) of this section “the relevant date”, in relation to medicinal products of any description to which an order made in accordance with subsection (1) of this section applies, means the date on which the order comes into operation, or the date on which the product licence applicable to medicinal products of that description (as mentioned in subsection (1)(b) of this section) comes into operation, whichever is the later.

Textual Amendments

F1 Word in s. 59(2)(b) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 32 (with regs. 2(4), 3)

Modifications etc. (not altering text)

C1 Pt. III amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), regs. 1(a), 2(12)

C2 S. 59 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.4

S. 59 modified (1.1.1995) by S.I. 1994/3144, reg.9(5)

S. 59 applied (1.1.1995) by S.I. 1994/3142, reg. 18(2)

S. 59 applied (31.3.1997) by S.I. 1997/322, reg. 34, Sch.5

C3 S. 59 amendment to earlier affecting provision SI 1994/3144 reg. 9 (30.10.2005) by Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), regs. 1(a), 2(12)