Medicines Act 1968

7 General provisions as to dealing with medicinal products. U.K.

(1) The following provisions of this section shall have effect subject to—

(a) any exemption conferred by or under this Part of this Act;

F1 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c) the provisions of section 48 of this Act.

(2) Except in accordance with a licence granted for the purposes of this section (in this Act referred to as a “product licence") no person shall, in the course of a business carried on by him, and in circumstances to which this subsection applies,—

(a) sell, supply or export any medicinal product, or

(b) procure the sale, supply or exportation of any medicinal product, or

(c) procure the manufacture or assembly of any medicinal product for sale, supply or exportation.

F2 (2A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F2 (2B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) No person shall import any medicinal product except in accordance with a product licence.

[F3 (3A) The restrictions imposed by subsections (2) and (3) of this section shall not apply where the medicinal product concerned is an investigational medicinal product within the meaning of the Clinical Trials Regulations.]

[F4 (3B) The restrictions imposed by subsections (2) and (3) of this section shall not apply where the medicinal product concerned is a homoeopathic medicinal product to which the 2001 Directive applies and which fulfils the conditions laid down in Article 14(1) of that Directive.]

(4) In relation to an imported medicinal product, subsection (2) of this section applies to circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or exportation or the manufacture or assembly for sale, supply or exportation of that product, has himself imported the product or procured its importation.

(5) In relation to any medicinal product which has not been imported, subsection (2) of this section applies to any circumstances in which the person selling, supplying or exporting the medicinal product in question, or procuring the sale, supply or exportation or the manufacture or assembly for sale, supply or exportation of that product,

[F5 (a) is responsible for the composition of the product, or

[F6 (b) if that product is a proprietary medicinal product F7 ... [F8 or an industrially produced medicinal productF7 ...], is responsible for the placing of the product on the market in the United Kingdom.]]

(6) For the purposes of subsection (5) of this section a person shall be taken to be responsible for the composition of a medicinal product if (but only if) in the course of a business carried on by him—

(a) he procures the manufacture of the product to his order by another person, where the order specifies, or incorporates by reference to some other document, particulars of the composition of the product ordered, whether those particulars amount to a complete specification or not, or

(b) he manufactures the product otherwise than in pursuance of an order which fulfils the conditions specified in the preceding paragraph.

[F9 (6A) F10 ... subsection (5)(b) of this section shall not apply if the product is—

F11 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) a radiopharmaceutical in which the radionuclide is in the form of a sealed source, F12 . . .

F12 (c) . . .

F13 (6B)] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F14 (7)

[F15 In this section—

F16 [F17 ...

“homoeopathic medicinal product" means any medicinal product (which may contain a number of principles) prepared from F18 ..., substances F18 ... called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State; ]

“proprietary medicinal product" means a ready-prepared medicinal product placed on the market in the United Kingdom under a special name and in a special pack;

“radiopharmaceutical" means a medicinal product which, when ready for use, contains one or more radionuclides included for a medicinal purpose; F19 ...]

F20 ...]

Textual Amendments

F1 S. 7(1)(b) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 7(a) (with regs. 2(4), 3)

F2 S. 7(2A)(2B) repealed (30.10.2005) by Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005 (S.I. 2005/2753), reg. 1(1), Sch. para. 1(2)

F3 S. 7(3A) inserted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 3

F4 S. 7(3B) inserted (30.10.2005) by Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005 (S.I. 2005/2753), reg. 1(1), Sch. para. 1(3)

F5 Words substituted by (E.W.)(S.) S.I. 1977/1050, art. 2(2) and (N.I.) S.R. 1977 No. 170, reg. 3

F6 S. 7(5)(b) substituted by S.I. 1983/1724, art. 2(2)

F7 Words in s. 7(5)(b) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 7(b) (with regs. 2(4), 3)

F8 Words in S. 7(5)(b) substituted (3.4.1992) by S.I. 1992/604, regs. 2(2), 4

F9 S. 7(6A)(6B) inserted (3.4.1992) by S.I. 1992/604, regs. 2(3), 4

F10 Words in s. 7(6A) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 7(c) (with regs. 2(4), 3)

F11 S. 7(6A)(a) omitted (8.11.2005) by virtue of The Blood Safety and Quality Regulations 2005 (S.I. 2005/50), regs. 1(2), 25(1)(a) (with reg. 2(2)-(4))

F12 In s. 7(6A) para.(c) and word

“or”omitted (13.2.1994) by S.I.1994/276, reg.3(3)(b) (which S.I. revoked and replaced defective S.I. 1994/101 before the latter S.I. came into force)

F13 S. 7(6B) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 7(d) (with regs. 2(4), 3)

F14 S. 7(7) substituted by S.I. 1983/1724, art. 2(3)

F15 Words in s. 7(7) substituted (3.4.1992) by S.I. 1992/604, regs. 2(4), 4

F16 Words in s. 7 repealed (30.10.2005) by Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005 (S.I. 2005/2753), reg. 1(1), Sch. para. 1(4)(a)

F17 Definitions in s. 7(7) inserted (13.2.1994) by S.I. 1994/276, reg. 3(4) (which S.I. revoked and replaced defective S.I. 1994/101 before the latter S.I. came into force)

F18 Words in s. 7 repealed (30.10.2005) by Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005 (S.I. 2005/2753), reg. 1(1), Sch. para. 1(4)(b)

F19 Word in s. 7(7) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 7(e)(i) (with regs. 2(4), 3)

F20 Words in s. 7(7) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 7(e)(ii) (with regs. 2(4), 3)

Modifications etc. (not altering text)

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

C2 S. 7 excluded by S.I. 1989/2325, art. 2(1)

C3 S. 7 excluded (11.12.1992) by S.I. 1992/2844, art. 2

S. 7 excluded (31.12.1994) by S.I. 1994/2986, reg.3(1)

S. 7 excluded (1.1.1995) by S.I. 1994/3142, reg. 18(1)

S. 7 excluded (1.1.1995) by S.I. 1994/3144, reg.9(2)

C4 S.7 excluded by S.I. 1981/164, art. 3

C5 S. 7 excluded (30.10.2005) by Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (S.I. 2005/2750), regs. 1(a), 10(1) (with Sch. 6)

C6 S. 7 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)

C7 S. 7(1)(a)(2)(4)(5)(6) applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2), Sch.