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MEDICINES ACT 1968

UK Public General Acts

Version 31/10/2016

1968 CHAPTER 67

Default Geographical Extent: E+W+S+N.I.


  • Part I. Administration
  • Part II. Licences and Certificates Relating to Medicinal Products
    • General provisions and exemptions
    • Applications for, and grant and renewal of, licences
    • Licences of right
    • Suspension, revocation and variation of licences
    • Clinical trials and medicinal tests on animals
    • Medicated animal feeding stuffs
    • Supplementary provisions
  • Part III. Further Provisions relating to Dealings with Medicinal Products
    • Provisions as to sale or supply of medicinal products
    • Exemptions from sections 52 and 53
    • Additional provisions
    • Offences, and provision for disqualification
  • Part IV. Pharmacies
    • Persons lawfully conducting retail pharmacy business
    • Registration of pharmacies
    • Provisions as to use of certain titles, descriptions and emblems
    • Disqualification, and removal of premises from register
    • Supplementary provisions
  • Part V. Containers, Packages and Identification of Medicinal Products
  • Part VI. Promotion of Sales of Medicinal Products
  • Part VII. British Pharmacopoeia and Other Publications
  • Part VIII. Miscellaneous and Supplementary Provisions
  • Version 31/10/2016
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  • Version 01/10/2007
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  • Version 01/03/2007
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  • Version 07/02/2007
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  • Version 01/10/2006
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  • Version 29/08/2006
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  • Version 05/12/2005
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  • Version 08/11/2005
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  • Version 30/10/2005
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  • Version 31/05/2005
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  • Version 01/01/2005
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  • Version 01/08/2004
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  • Version 01/05/2004
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  • Version 31/01/2004
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  • Version 09/07/2003
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  • Version 01/04/2002
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  • Version 27/12/1999
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  • Version 01/07/1996
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  • Version 29/09/1995
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  • Version 03/10/1994
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  • Version 13/02/1994
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  • Version 05/11/1993
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  • Version 03/04/1992
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  • Version 01/04/1992
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  • Version 01/10/1991
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  • Version 08/04/1991
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  • Version 08/03/1991
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  • Version 01/02/1991

Introductory Text

Medicines Act 1968

1968 CHAPTER 67

An Act to make new provision with respect to medicinal products and related matters, and for purposes connected therewith.

[25th October 1968]

Annotations:

Modifications etc. (not altering text)

C1 References to Ministers of Northern Ireland to be construed as references to heads of Northern Ireland departments: Northern Ireland Constitution Act 1973 (c. 36), Sch. 5 para. 7

C2 Functions of Ministry of Home Affairs for Northern Ireland transferred to Department of Health and Social Services for Northern Ireland by S.R. & O. (N.I.) 1973 No. 504, art. 5, Sch. 2 Pt. I

C3 Functions exercisable by Ministers jointly under this Act (except s. 108(4)(7) now exercisable by those Ministers and Secretary of State for Wales jointly: S.I. 1978/272, art. 2(3), Sch. 1; references to Minister of Agriculture, Fisheries and Food amended (W.): ibid., art. 11(6)

C4 Act restricted by S.I. 1985/273, reg. 3(3)

C5 Act amended (N.I.) (1.4.1992) by S.I. 1991/194 (N.I. 1), art. 7(2), Sch. 2 para. 5(1); S.R. 1991/131, art. 2(e), Sch. Pt. III

C6 Certain provisions of the Act extended and modified (14.2.1994) by S.I. 1994/105, reg. 19, Sch. 4

C7 Act excluded in part (6.5.1998) by S.I. 1998/1046, reg. 43

Act excluded in part (6.5.1998) by S.I. 1998/1047, reg. 74

Act excluded in part (2.8.1999) by S.I. 1999/1871, reg. 92(1)

C8 Act: functions transferred (27.12.1999) by S.I. 1999/3142, art. 2(1)(2) (with art. 4)

Act: functions transferred (27.3.2002) by S.I. 2002/794, art. 3(1)(c)(2)(7) (with art. 6)

C9 Act excluded (30.10.2005) by The Veterinary Medicines Regulations 2005 (S.I. 2005/2745), reg. 44(1)

C10 Act amendment to earlier affecting provision SI 1994/3144 reg. 10 Sch. 4 para. 10(b) (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 11(b) (with regs. 2(4), 3)

C11 Act amendment to earlier affecting provision SI 1994/3144 reg. 10 Sch. 4 para. 9(b) (1.10.2006) by The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 11(a) (with regs. 2(4), 3)


Part I
Administration



Annotations:

Modifications etc. (not altering text)

C12 Pt. I (ss. 1-5) modified (3.4.1992) by S.I. 1992/605, regs. 2(3), 3


[F1 1 Ministers responsible for administration of Act.

In this Act, “the Ministers” has the meaning given by regulation 6(6) to (8) of the 2012 Regulations (but as if references in that regulation to those Regulations were references to this Act). ]

Annotations:

Amendments (Textual)

F1 S. 1 substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916) , reg. 1(2) , Sch. 34 para. 2 (with Sch. 32 )

Modifications etc. (not altering text)

C13 Pt. I(ss. 1–5) extended by S.I. 1984/187, art. 2

C14 S. 1 extended (3.4.1992) by S.I. 1992/605, regs. 2(4), 3


F2 2 Establishment of Medicines Commission.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations:

Amendments (Textual)

F2 S. 2 repealed (30.10.2005) by Medicines (Advisory Bodies) Regulations 2005 (S.I. 2005/1094), regs. 1(1), 2(2)


F3 2A. Establishment of the Commission on Human Medicines

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations:

Amendments (Textual)

F3 Ss. 2A-9 repealed (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)


F3 3 Functions of the Commission

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations:

Amendments (Textual)

F3 Ss. 2A-9 repealed (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)


F3 4 Establishment of committees.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations:

Amendments (Textual)

F3 Ss. 2A-9 repealed (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)


F3 5 Supplementary provisions as to Commission and committees.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations:

Amendments (Textual)

F3 Ss. 2A-9 repealed (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)


Part II
Licences and Certificates Relating to Medicinal Products



General provisions and exemptions


F3 6 The licensing authority.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations:

Amendments (Textual)

F3 Ss. 2A-9 repealed (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)


F3 7 General provisions as to dealing with medicinal products.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations:

Amendments (Textual)

F3 Ss. 2A-9 repealed (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)


F3 8 Provisions as to manufacture and wholesale dealing.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations:

Amendments (Textual)

F3 Ss. 2A-9 repealed (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)


F3 9 Exemptions for doctors and dentists

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations:

Amendments (Textual)

F3 Ss. 2A-9 repealed (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 35 (with Sch. 32)


10 Exemptions for pharmacists.

(1) F4 ... the restrictions imposed by [F5 regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations] do not apply to anything which is done in a registered pharmacy, a hospital [F6 , a care home service ] or a health centre and is done there by or under the supervision of a pharmacist and consists of—

(a) preparing or dispensing a medicinal product in accordance with a prescription given by [F7 an appropriate practitioner] , or
(b) assembling a medicinal product [F8 provided that where the assembling takes place in a registered pharmacy—
(i) it shall be in a registered pharmacy at which the business in medicinal products carried on is restricted to retail sale or to supply in circumstances corresponding to retail sale and the assembling is done with a view to such sale or supply either at that registered pharmacy or at any other such registered pharmacy forming part of the same retail pharmacy business, and
(ii) the medicinal product has not been the subject of an advertisement] ; and those restrictions do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a practitioner, or of procuring the assembly of a medicinal product.
F9 ( 2 ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Those restrictions do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist in accordance with a specification furnished by the person to whom the product is or is to be sold or supplied, where—

(a) the product is prepared or dispensed for administration to that person or to a person under his care, F10 ...
F10 ( b ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(4) Without prejudice to the preceding subsections, the restrictions imposed by [F11 regulations 17(1) (manufacturing of medicinal products) and 46 (requirement for authorisation) of the 2012 Regulations] do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of—

(a) preparing or dispensing a medicinal product for administration to a person where the pharmacist is requested by or on behalf of that person to do so in accordance with the pharmacist’s own judgment as to the treatment required, and that person is present in the pharmacy at the time of the request in pursuance of which that product is prepared or dispensed, or
(b) preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1) (a) or subsection (3) of this section or in paragraph (a) of this subsection [F12 provided that such stock is prepared with a view to retail sale or to supply in circumstances corresponding to retail sale and the preparation is done with a view to such sale or supply either at that registered pharmacy or at any other registered pharmacy forming part of the same retail pharmacy business] ;
and those restrictions do not apply to anything which is done in a hospital or a health centre by or under the supervision of a pharmacist and consists of preparing a stock of medicinal products with a view to dispensing them as mentioned in subsection (1) (a) of this section.
[F13 (5) Without prejudice to the preceding subsections, the restrictions imposed by [F14 regulation 46 of the 2012 Regulations] do not apply to the preparation or dispensing in a registered pharmacy of a medicinal product by or under the supervision of a pharmacist where—

(a) the medicinal product is prepared or dispensed otherwise than in pursuance of an order from any other person, and
(b) the medicinal product is prepared with a view to retail sale or supply in circumstances corresponding to retail sale at the registered pharmacy at which it is prepared, and
(c) the medicinal product has not been the subject of an advertisement.
(6) Without prejudice to the preceding subsections, the restrictions imposed by [F15 regulation 17(1) of the 2012 Regulations] do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and consists of preparing a medicinal product with a view to retail sale or to supply in circumstances corresponding to retail sale at that registered pharmacy.

F16 ( 6A ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F17 ( 7 ). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F18 (7A) The F19 ... Ministers may make regulations prescribing conditions which must be complied with if a thing is to be considered for the purposes of this section as done under the supervision of a pharmacist.

(7B) Conditions prescribed under subsection (7A) may relate to supervision in the case where the pharmacist is not at the place where the thing is being done, and in that case the thing is not to be so considered if no such conditions are prescribed.

(7C) In any case, compliance with any applicable conditions is sufficient for the thing to be so considered.]

(8) For the purposes of this section “advertisement" shall have the meaning assigned to it by [F20 regulation 7 (advertisements relating to medicinal products) of the 2012 Regulations] . ]

[F21 (9) In subsection (1) of this section, “care home service" has the meaning given by [F22 paragraph   2 of schedule   12 to the Public Services Reform (Scotland) Act 2010 (asp   8) ] . ]

Annotations:

Amendments (Textual)

F4 Words in s. 10(1) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 10(a) (with regs. 2(4), 3)

F5 Words in s. 10(1) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 3(b) (with Sch. 32)

F6 Words in s. 10(1) inserted (S.) (1.4.2002) by 2001 asp 8, s. 79, Sch. 3 para. 5(a); S.S.I. 2002/162, art. 2(h) (subject to arts. 3-13)

F7 Words in s. 10(1) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 3(a) (with Sch. 32)

F8 Words added by S.I. 1971/1445, art. 3(a)

F9 S. 10(2) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 10(b) (with regs. 2(4), 3)

F10 S. 10(3)(b) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 10(c) (with regs. 2(4), 3)

F11 Words in s. 10(4) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 3(b) (with Sch. 32)

F12 Words added by S.I. 1971/1445, art. 3(b)

F13 S. 10(5)–(8) added by S.I. 1971/1445, art. 3(c)

F14 Words in s. 10(5) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 3(c) (with Sch. 32)

F15 Words in s. 10(6) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 3(d) (with Sch. 32)

F16 S. 10(6A) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 10(d) (with regs. 2(4), 3)

F17 S. 10(7) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 3(e) Sch. 35 (with Sch. 32)

F18 S. 10(7A)-(7C) inserted (19.7.2006 for specified purposes) by Health Act 2006 (c. 28), ss. 26(1), 83(1)(e)

F19 Word in s. 10(7A) omitted (1.10.2006) by virtue of The Veterinary Medicines Regulations 2006 (S.I. 2006/2407), reg. 1, Sch. 8 para. 10(e) (with regs. 2(4), 3)

F20 Words in s. 10(8) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 3(f) (with Sch. 32)

F21 S. 10(9) added (S.) (1.4.2002) by 2001 asp 8, ss. 79, Sch. 3 para. 5(b); S.S.I. 2002/162, art. 2(h) (subject to arts. 3-13)

F22 Words in s. 10(9) substituted (28.10.2011) by The Public Services Reform (Scotland) Act 2010 (Consequential Modifications of Enactments) Order 2011 (S.I. 2011/2581), art. 1(2)(b), Sch. 2 para. 1

Modifications etc. (not altering text)

C15 Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)

C16 S. 10 amended (E.W.S.) (prosp) by 1954 c. 61, s. 13I(1)(b) (as inserted (prosp.) by 1997 c. 19, ss. 1, 2(1), Sch. para. 2)