Medicines Act 1968

26 Scope of licence of right in different cases. U.K.

(1) Where a person is entitled to the grant of a licence of right by reason that subsection (2) or subsection (3) of section 16 of this Act has effect in relation to him, he shall be entitled to the grant of a product licence; but, subject to the following provisions of this section,—

(a) 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 the subsection in question are proved to have been fulfilled, and

(b) where the conditions specified in subsection (3) (but not those specified in subsection (2)) of that section are proved to have been fulfilled, then, without prejudice to the preceding paragraph, the licence granted shall be limited to the importation of medicinal products.

(2) Where a person is entitled to the grant of a licence of right by reason that subsection (4) of section 16 of this Act has effect in relation to him, he shall be entitled to the grant of a manufacturer’s licence; but, subject to the following provisions of this section, the licence shall be granted so as not to extend—

(a) to medicinal products of any description, unless it is proved that medicinal products of that description were being manufactured or assembled in the course of the business in question during the period mentioned in that subsection, or

(b) to operations of any kind other than those in relation to which that subsection has been proved to have effect.

(3) Where a person is entitled to the grant of a licence of right by reason that subsection (5) of section 16 of this Act has effect in relation to him, he shall be entitled to the grant of a wholesale dealer’s licence.

(4) A licence of right granted in accordance with subsection (1) or subsection (2) of this section shall (without prejudice to either of those subsections) be granted subject to such provisions as appear to the licensing authority to be requisite for securing that the specification of medicinal products of any description to which the licence relates, and the purposes for which any such products are authorised by the licence to be sold, supplied, exported, imported, manufactured or assembled, will be in accordance with those stated in the application for the licence.

(5) Where a licence of right—

(a) is granted in accordance with subsection (1) or subsection (2) of this section in circumstances where, immediately before the first appointed day, the manufacture of medicinal products of any description to which the licence relates was authorised by a licence issued under Part I of the M1 Therapeutic Substances Act 1956 or under Part II of the M2 Diseases of Animals Act 1950 or of the M3 Diseases of Animals Act (Northern Ireland) 1958, or

(b) is granted in accordance with subsection (1) of this section in circumstances where, immediately before the first appointed day, the importation of medicinal products of any such description was authorised by a licence so issued,

the provisions of the licence so issued, and the provisions of any regulations made under Part I of the M4 Therapeutic Substances Act 1956 or (as the case may be) of any order made under Part II of the said Act of 1950 or of the said Act of 1958, in so far as immediately before that day they were applicable to medicinal products of that description, shall be deemed to be incorporated in the licence of right granted under this Act, in its application to medicinal products of that description, and shall have effect accordingly as provisions of the licence of right until it expires or is renewed.

(6) A breach of any requirement imposed by this section in respect of the grant of a licence shall not invalidate the licence; and, except as provided by section 107 of this Act, the duty of the licensing authority to comply with any such requirement shall not be enforceable by any legal proceedings.

Modifications etc. (not altering text)

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

Marginal Citations

M1 1956 c. 25.

M2 1950 c. 36.

M3 1958 c. 13 (N.I.)

M4 1956 c. 25.