Medicines Act 1968

49 Special provisions in respect of exporting certain products. U.K.

(1) Nothing in subsection (1) of section 48 of this Act shall affect the operation of any of the provisions of sections 7 to 47 of this Act in relation to any medicinal product falling within a class specified in an order made under this section by the Health Ministers or the Agriculture Ministers.

(2) No class of medicinal products shall be specified in an order made by the Health Ministers or the Agriculture Ministers under this section unless it appears to the Ministers making the order to be requisite to do so for securing that any exemption conferred by section 48(1) of this Act does not apply to medicinal products consisting wholly or partly of substances the purity or potency of which cannot, in their opinion, be adequately tested by chemical means.

(3) Subsections (3) to (7) of section 48 of this Act shall not have effect in relation to medicinal products of any description falling within a class specified in an order under this section which is in force immediately before the day appointed for the purposes of subsection (1) of that section.

(4) Subject to the next following subsection, section 7(2) of this Act shall not have effect in relation to a person in respect of his exporting, or procuring the exportation of, medicinal products of any description falling within a class specified in an order under this section which is in force immediately before the first appointed day if, in the course of a business carried on by that person,—

(a) substantial quantities of medicinal products of that description (that is to say, quantities exceeding those required for distribution as samples) were exported or procured to be exported during the period of twenty-four months ending with the first appointed day, and

(b) during the whole of that period further substantial quantities of medicinal products of that description were available, or could within a reasonable time have been made available, to be so exported or procured to be exported if required.

(5) Sections 17 and 25 of this Act shall have effect in relation to subsection (4) of this section as they have effect in relation to subsections (2) to (5) of section 16 of this Act.

(6) Where a person is entitled to the grant of a licence of right by reason that subsection (4) of this section has effect in relation to him, he shall be entitled to the grant of a product licence; but, subject to the next following subsection, the licence shall be granted so as not to extend to medicinal products of any description other than those in respect of which the conditions specified in that subsection are proved to the reasonable satisfaction of the licensing authority to have been fulfilled, and shall be limited to exporting, or procuring the exportation of, medicinal products.

(7) Subsection (5) of section 26 of this Act (with the omission of paragraph (b) of that subsection) and subsection (6) of that section shall have effect in relation to the grant of a licence of right in accordance with subsection (6) of this section as those subsections have effect in relation to the grant of such a licence in accordance with subsection (1) of that section.

(8) In relation to any application for a licence of right which is made by virtue of section 25 of this Act as applied by subsection (5) of this section, the provisions of section 27 of this Act shall have effect subject to such modifications as may be specified by order made by the Ministers for the purposes of this subsection.

Modifications etc. (not altering text)

C1 Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)