Medicines Act 1968

8 Provisions as to manufacture and wholesale dealing. U.K.

(1) The following provisions of this section shall have effect without prejudice to the operation of section 7 of this Act, but subject to the exemptions and provisions referred to in paragraphs [F1 (a) and (c)] of subsection (1) of that section.

(2) [F2 Subject to [F3 subsections (2A) and (2C)] of this section]No person shall, in the course of a business carried on by him, [F4 manufacture, assemble or import from a third country] any medicinal product except in accordance with a licence granted for the purposes of this subsection (in this Act referred to as a “manufacturer’s licence”).

[F5 (2A) In the case of a medicinal product that is an investigational medicinal product, the restrictions imposed by subsection (2) of this section only apply—

(a) if the product has a product licence or marketing authorization, and

(b) to the extent that the manufacture or assembly of the product is in accordance with the terms and conditions of that licence or authorization.]

[F5 (2B) In subsection (2A) of this section—

• “investigational medicinal product” has the meaning given by the Clinical Trials Regulations; and

• “marketing authorization” means—

  (a)

  a marketing authorization issued by a competent authority in accordance with [F6 the 2001 Directive] , or

  (b)

  a marketing authorization granted by the European Commission under Council Regulation ( EEC ) 2309/93 [F7 or under Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency] . ]

[F8 (2C) The prohibition in subsection (2) does not apply to a person who, in connection with the importation of a medicinal product from a third country—

(a) provides facilities solely for transporting the product, or

(b) in the course of a business carried on by him as an import agent, imports the medicinal product solely to the order of another person who holds a manufacturer’s licence authorising the importation of the product.]

[F8 (2D) The Ministers may prescribe requirements (either generally or in relation to a prescribed class of medicinal product or activity)—

(a) with which the holder of a manufacturer’s licence must comply, and

(b) which are to have effect as if they were provisions of the licence.]

[F9 ( 3 ) [F10 Subject to [F11 subsections (3C) and (3D)] of this section,] no person shall, in the course of a business carried on by him—

(a) sell, or offer for sale, any medicinal product by way of wholesale dealing, or

( b ) distribute, otherwise than by way of sale, any proprietary medicinal product F12 [F13 ... or industrially produced medicinal product F12 ...] which has been imported, but was not consigned from a member State,

except in accordance with a [F14 wholesale dealer’s licence].]

[F15 (3A) Without prejudice to the generality of subsection (3) of this section but subject to [F16 subsections (3C) and (3D)], no person shall, in the course of a business carried on by him, distribute by way of wholesale dealing a product to which [F17 the 2001 Directive applies] apply except in accordance with a wholesale dealer’s licence.

(3B) Distribution of such a product by way of wholesale dealing shall not be taken to be in accordance with a wholesale dealer’s licence unless, in particular, it occurs in the course of a business which is carried on at a place or places specified in the licence.

(3C) The restrictions imposed by subsections (3) and (3A) of this section do not apply to anything done in relation to a product to which [F17 the 2001 Directive applies] apply by the holder of a manufacturer’s licence in respect of it.]

[F18 (3D) The restrictions imposed by subsections (3) and (3A) of this section do not apply where the product concerned is an investigational medicinal product within the meaning given by the Clinical Trials Regulations.]

[F19 (3E) The Ministers may prescribe requirements (either generally or in relation to a prescribed class of medicinal product or activity)—

(a) with which the holder of a wholesale dealer’s licence must comply, and

(b) which are to have effect as if they were provisions of the licence.]

[F20 (4) F21 ... subsection (3)(b) of this section shall not apply if the product is—

F22 ( a ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) a radiopharmaceutical in which the radionuclide is in the form of a sealed source, [F23 . . .]

F23 ( c ) . . .

F24 ( 5 ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6) In this section, [F25 [F26 “proprietary medicinal product” and “radiopharmaceutical”] have the same meanings as in section 7 of this Act.]

[F27 (7) In this section any reference to distribution of a product by way of wholesale dealing is a reference to—

(a) selling or supplying it, or

(b) procuring, holding or exporting it for the purposes of sale or supply,

to a person who receives it for the purposes of—

(i) selling or supplying it, or

(ii) administering it or causing it to be administered to one or more human beings,

in the course of a business carried on by that person.

(8) In this Act any reference to a wholesale dealer’s licence is a reference to a licence granted for the purposes of subsection (3) or (3A) of this section.]]

Textual Amendments

F1 Words in s. 8(1) substituted (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 8(a) (with regs. 2(4), 3)

F2 Words in s. 8(2) inserted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 4(2)

F3 Words in s. 8(2) substituted (30.10.2005) by The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/2789), reg. 1(1), Sch. 5 para. 1(2)(a) (with Sch. 6)

F4 Words in s. 8(2) substituted (30.10.2005) by The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/2789), reg. 1(1), Sch. 5 para. 1(2)(b) (with Sch. 6)

F5 S. 8(2A)(2B) inserted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 4(3)

F6 Words in s. 8(2B) substituted (29.12.2008) by The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2008 (S.I. 2008/3097), regs. 1(1), 4(a)(i)

F7 Words in s. 8(2B) inserted (29.12.2008) by The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2008 (S.I. 2008/3097), regs. 1(1), 4(a)(ii)

F8 S. 8(2C)(2D) inserted (30.10.2005) by The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/2789), reg. 1(1), Sch. 5 para. 1(3) (with Sch. 6)

F9 S. 8(3)(4) substituted for s. 8(3) by (E.W.)(S.) S.I. 1977/1050, art. 3(2) and (N.I.) S.R. 1977 No. 170, reg. 4

F10 Words in s. 8(3) inserted (14.4.1993) by S.I. 1993/834, reg. 2(2)

F11 Words in s. 8(3) substituted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 4(4)

F12 Words in s. 8(3)(b) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 8(b) (with regs. 2(4), 3)

F13 Words in s. 8(3)(b) substituted (3.4.1992) by virtue of S.I.1992/604, regs. 3(2), 4

F14 Words in s. 8(3) substituted (14.4.1993) by S.I. 1993/834, reg. 2(3)

F15 S. 8(3A)-(3C) inserted (14.4.1993) by S.I. 1993/834, reg. 2(4)

F16 Words in s. 8(3A) substituted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 4(4)

F17 Words in s. 8(3A)(3C) substituted (28.2.2002) by S.I. 2002/236, reg. 2(a)(i)

F18 S. 8(3D) inserted (1.5.2004) by Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2004/1031), reg. 1, Sch. 10 para. 4(5)

F19 S. 8(3E) inserted (30.10.2005) by The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 (S.I. 2005/2789), reg. 1(1), Sch. 5 para. 1(4) (with Sch. 6)

F20 S. 8(4)(5)(6) substituted (3.4.1992) for s. 8(4) by virtue of S.I. 1992/604, regs. 3(3), 4

F21 Words in s. 8(4) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 8(c) (with regs. 2(4), 3)

F22 S. 8(4)(a) omitted (8.11.2005) by virtue of The Blood Safety and Quality Regulations 2005 (S.I. 2005/50), regs. 1(2), 25(1)(b) (with reg. 2(2)-(4))

F23 In S. 8(4) paragraph (c) and words immediately preceeding it omitted (13.2.1994) by virtue of S.I. 1994/276, reg. 4(2)(b) (which S.I. revoked and replaced defective S.I. 1994/101 before the latter S.I. came into force)

F24 S. 8(5) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 8(d) (with regs. 2(4), 3)

F25 Words in s.8(6) inserted (13.2.1994) by S.I. 1994/276, reg. 4(3) (which S.I. revoked and replaced defective S.I. 1994/101 before the latter S.I. came into force)

F26 Words in s. 8(6) substituted (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 8(e) (with regs. 2(4), 3)

F27 S. 8(7)(8) added (14.4.1993) by S.I. 1993/834, reg. 2(5)

Modifications etc. (not altering text)

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

C2 S. 8 excluded by S.I. 1989/2325, art. 2(3)

C3 S. 8(2) excluded by S.I. 1979/1114, arts. 2, 4 and by S.I. 1979/1585, arts. 2, 3

C4 S. 8(3) excluded by S.I. 1989/2322, art. 2(1)

C5 S. 8(3) excluded by S.I. 1990/566, art. 2(1)

C6 S. 8(3)(b) excluded by S.I. 1989/2322, art. 2(3)

C7 S. 8(3)(b) excluded by S.I. 1990/566, art. 2(3)