Source: http://www.legislation.gov.uk/ukpga/1968/67
Timestamp: 2013-12-10 14:35:30
Document Index: 622297374

Matched Legal Cases: ['art. 5', 'art. 2', 'art. 11', 'art. 7', 'art. 2', 'art. 2', 'art. 4', 'art. 3', 'art. 6', 'art. 5', 'art. 4', 'art. 5', 'art. 5', 'art. 4', 'art. 5', 'art. 6', 'art. 5', 'art. 5', 'art. 2', 'art. 2', 'art. 3', 'art. 4', 'art. 7', 'art. 2', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 7', 'art. 5', 'art. 5', 'art. 4', 'art. 5', 'art. 6', 'art. 2', 'art. 3', 'art. 2', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 3', 'art. 3', 'art. 2', 'art. 2', 'art. 2', 'art. 2', 'art. 2', 'art. 3', 'art. 310', 'art. 2', 'art. 3', 'art. 3', 'art. 3']

Skip to main contentSkip to navigationlegislation.gov.ukThe National ArchivesHelpSite MapAccessibilityContact UsCymraegHomeAbout UsBrowse LegislationNew LegislationChanges To LegislationSearch LegislationSearch LegislationTitle: (or keywords in the title)Year:Number:Type:All Legislation (excluding draft)All Primary Legislation UK Public General Acts UK Local Acts Acts of the Scottish Parliament Acts of the National Assembly for Wales Measures of the National Assembly for Wales Church Measures Acts of the Northern Ireland Assembly Acts of the Old Scottish Parliament Acts of the English Parliament Acts of the Old Irish Parliament Acts of the Parliament of Great Britain Northern Ireland Orders in Council Measures of the Northern Ireland Assembly Acts of the Northern Ireland ParliamentAll Secondary Legislation UK Statutory Instruments Wales Statutory Instruments Scottish Statutory Instruments Northern Ireland Statutory Rules Church Instruments UK Ministerial Orders UK Statutory Rules and OrdersAll Draft Legislation UK Draft Statutory Instruments Scottish Draft Statutory Instruments Northern Ireland Draft Statutory RulesAll Impact Assessments UK Impact AssessmentsSearchAdvanced SearchMedicines Act 1968You are here:1968 c. 67Whole ActTable of ContentsContentMore ResourcesPreviousNextPlain ViewPrint OptionsWhat VersionLatest available (Revised)Original (As enacted)Advanced FeaturesShow Geographical Extent(e.g. England, Wales, Scotland, Northern Ireland)Show Timeline of ChangesOpening OptionsOpen whole ActOpen Act without schedulesOpen Schedules onlyMore ResourcesOriginal Print PDFView moreChanges to legislation:There are outstanding changes not yet made by the legislation.gov.uk editorial team to Medicines Act 1968. Any changes that have already been made by the team appear in the content and are referenced with annotations.Changes to LegislationRevised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.E+W+S+N.I.Medicines Act 19681968 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:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Modifications etc. (not altering text)C1References 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. 7C2Functions 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. IC3Functions 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)C4Act restricted by S.I. 1985/273, reg. 3(3)C5Act 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. IIIC6Certain provisions of the Act extended and modified (14.2.1994) by S.I. 1994/105, reg. 19, Sch. 4C7Act excluded in part (6.5.1998) by S.I. 1998/1046, reg. 43Act excluded in part (6.5.1998) by S.I. 1998/1047, reg. 74Act excluded in part (2.8.1999) by S.I. 1999/1871, reg. 92(1)C8Act: 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) Part IE+W+S+N.I. AdministrationAnnotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Modifications etc. (not altering text)C9Pt. I (ss. 1-5) modified (3.4.1992) by S.I. 1992/605, regs. 2(3), 31 Ministers responsible for administration of Act. E+W+S+N.I.(1)In this Act—
(a)“the Health Ministers” means the following Ministers, that is to say, [F1the Secretary of State concerned with health in England] and the Minister of Health and Social Services for Northern Ireland, and, in the case of anything falling to be done by the Health Ministers, means those Ministers acting jointly;
(b)“the Agriculture Ministers” means the following Ministers, that is to say, the [F2Secretary of State for Environment, Food and Rural Affairs], F3. . . and the Minister of Agriculture for Northern Ireland, and, in the case of anything falling to be done by the Agriculture Ministers, means those Ministers acting jointly,
and “the Ministers” means F4. . . the Ministers [F5for Northern Ireland]specified in paragraphs (a) and (b) of this subsection [F6and the Secretary of State], and, in the case of anything falling to be done by the Ministers, means all those Ministers acting jointly.
(2)In this Act, except where the contrary is expressly provided, “the appropriate Ministers”—
(a)for the purpose of performing any function under this Act (whether by the making of any regulations or order or otherwise) where the function is performed exclusively in relation to matters other than veterinary drugs and the treatment of diseases of animals, means the Health Ministers; and
(b)in any other case, means the Ministers.
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Amendments (Textual)F1Words in s. 1(1)(a) substituted (27.12.1999) by S.I. 1999/3142, art. 5, Sch. para. 1(1) (with art. 4)F2S. 1(1): words in definition of “the Agricultural Ministers”substituted (27.3.2002) by S.I. 2002/794, art. 5(1), Sch. 1 para. 15(1)(2) (with arts. 5(3), 6)F3Words in s. 1(1)(b) repealed (27.12.1999) by S.I. 1999/3142, art. 5, Sch. para. 1(2) (with art. 4)F4Word in s. 1(1) repealed (27.3.2002) by S.I. 2002/794, art. 5(2), Sch. 2 (with art. 6)F5S. 1(1): words in definition of “the Ministers”inserted (27.3.2002) by S.I. 2002/794, art. 5(1), Sch. 1 para. 15(1)(3)(a) (with arts. 5(3), 6)F6S. 1(1): words in definition of “the Ministers”inserted (27.3.2002) by S.I. 2002/794, art. 5(1), Sch. 1 para. 15(1)(3)(b) (with arts. 5(3), 6)Modifications etc. (not altering text)C10Pt. I(ss. 1–5) extended by S.I. 1984/187, art. 2C11S. 1 extended (3.4.1992) by S.I. 1992/605, regs. 2(4), 32 Establishment of Medicines Commission. E+W+S+N.I.(1)There shall be established a body to be called the Medicines Commission (in this Act referred to as “the Commission”) to perform the functions assigned to the Commission by or under this Act.
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Amendments (Textual)F7S. 2(6) repealed by House of Commons Disqualification Act 1975 (c. 24), Sch. 3 and Northern Ireland Assembly Disqualification Act 1975 (c. 25), Sch. 3 Pt. IModifications etc. (not altering text)C12Pt. I(ss. 1–5) extended by S.I. 1984/187, art. 2C13S. 2: Certain functions made exercisable (S.) (30.6.1999) by virtue of S.I. 1999/1748, art. 3, Sch. 1 para. 3C14S. 2(2)(4) amended (S.) (1.7.1999) by S.I. 1999/1750, art. 4, Sch. 3 (with art. 7)3 General functions of Commission. E+W+S+N.I.(1)The Commission shall give to any one or more of the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act advice on matters relating to the execution of this Act or the exercise of any power conferred by it, or otherwise relating to medicinal products, where either the Commission consider it expedient, or they are requested by the Minister or Ministers in question, to do so.
(2)Without prejudice to the preceding subsection, and to any other duties or powers imposed or conferred on the Commission by or under this Act, it shall be the duty of the Commission—
(a)to make recommendations to the Ministers with regard to the number of committees to be established under section 4 of this Act and with regard to the functions to be assigned to each such committee;
(b)in relation to any such committee, to recommend to any of the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act such persons (whether members of the Commission or other persons) as the Commission consider well qualified to serve as members of that committee;
(c)from time to time (where either the Commission consider it expedient, or they are requested by the Ministers, to do so) to review the committees established under section 4 of this Act and to make recommendations to the Ministers with regard to any changes in their number or functions which the Commission consider appropriate;
(d)to advise the licensing authority in cases where the authority either are required by the provisions of Part II of this Act to consult the Commission or, without being required to do so, elect to consult the Commission with respect to any matter arising under those provisions; and
(e)to undertake the functions specified in subsection (3) of section 4 of this Act, in so far as those functions relate to medicinal products and are not for the time being assigned to a committee established under that section, and to undertake the functions mentioned in subsection (4) of that section in so far as those functions are not for the time being assigned to such a committee.
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Modifications etc. (not altering text)C15Pt. I(ss. 1–5) extended by S.I. 1984/187, art. 2C16S. 3 applied (1.1.1995) by S.I. 1994/3142, reg. 18(3)S. 3 modified (1.1.1995) by S.I. 1994/3144, reg.9(1)4 Establishment of committees. E+W+S+N.I.(1)The Ministers, the Health Ministers or the Agriculture Ministers, having regard to any recommendations made by the Commission under section 3(2) of this Act, and after consultation with such organisations as the Ministers concerned consider appropriate, may by order establish one or more committees under this section.
(2)A committee may be so established for any purpose, or combination of purposes, connected with the execution of this Act or the exercise of any power conferred by it, either generally or in relation to any particular class of substances or articles to which any provision of this Act is applicable.
(3)Without prejudice to the generality of subsection (2) of this section, in relation to any such class of substances or articles a committee may be established under this section for either or both of the following purposes, that is to say—
(a)giving advice with respect to safety, quality or efficacy, or with respect to all or any two of those matters;
(b)promoting the collection and investigation of information relating to adverse reactions, for the purpose of enabling such advice to be given.
(4)A committee or committees may be established under this section for the purpose of performing any function under Part VII of this Act in relation to the British Pharmacopoeia or in relation to any such compendium or list of names or other publication as is mentioned in that Part of this Act.
(5)The Ministers by whom a committee is established under this section shall appoint the members of the committee, and shall appoint one of those members to be chairman of the committee.
[F8(5A)Where a committee is established under this section for purposes including the consideration of veterinary products as defined in section 29(2) of the Food Standards Act 1999, one member of the committee shall be appointed by the Ministers establishing the committee on the nomination of the Food Standards Agency.]
(6)In this Act “the appropriate committee”, for the purposes of any provision of this Act under which a function falls to be performed, means such committee established under this section for purposes which consist of or include any of those specified in subsection (3) of this section as the authority performing that function considers appropriate in the circumstances.
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Amendments (Textual)F8S. 4(5A) inserted (1.4.2000) by 1999 c. 28, s. 18, Sch. 3 Pt III, para. 15(2) (with s. 38); S.I. 2000/1066, art. 2Modifications etc. (not altering text)C17Pt. I(ss. 1–5) extended by S.I. 1984/187, art. 2C18S. 4 applied (1.1.1995) by S.I. 1994/3142, reg. 18(3)S. 4 modified (1.1.1995) by S.I. 1994/3144, reg. 9(1)C19S. 4(1)(5): Certain functions made exercisable (S.) (30.6.1999) by S.I. 1999/1748, art. 3, Sch. 1 para. 3C20S. 4(2)(3) modified (6.3.2002 for certain purposes and 1.4.2002 otherwise) by 2001 c. 15, s. 63(8) (with ss. 64(9), 65(4)); S.I. 2002/1095, art. 2(1)C21s. 4(5) amended (S.) (1.7.1999) by S.I. 1999/1750, art. 4, Sch. 3 (with art. 7)5 Supplementary provisions as to Commission and committees. E+W+S+N.I.(1)The provisions of Schedule 1 to this Act shall have effect with respect to the Commission, to any committee established under section 4 of this Act and to the other matters mentioned in that Schedule.
(2)The Commission shall, at such time in each year as the Ministers may direct, send to the Ministers [F9specified in paragraphs (a) and (b) of section 1(1) of this Act] a report with respect to the performance of their functions and of the functions of any committee appointed by them; and [F10the Secretary of State]. . .shall F11. . . lay before Parliament a copy of every such report.
(3)Each committee established under section 4 of this Act shall, at such time in each year as the Commission may direct, send to the Commission and to the Ministers [F9specified in paragraphs (a) and (b) of section 1(1) of this Act] a report with respect to the performance of their functions; and any report of the Commission under this section may include such information relating to the performance of the functions of any such committee as the Commission consider appropriate.
(4)Subject to the next following subsection, the Ministers, after consultation with the Commission, may by order—
(a)add to, revoke or vary any of the provisions of Schedule 1 to this Act in its application to the Commission, or
(b)confer on the Commission any new function for purposes connected with medicinal products or related matters, or
(c)terminate any function conferred on the Commission by or under this Act, or
(d)vary any such function, so however as not to confer on the Commission any new function which could not be conferred on them in accordance with paragraph (b) of this subsection.
(5)No order shall be made under this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Amendments (Textual)F9Words in s. 5(2)(3) inserted (27.3.2002) by S.I. 2002/794, art. 5(1), Sch. 1 para. 16 (with arts. 5(3), 6)F10Words in s. 5(2) substituted (27.12.1999) by S.I. 1999/3142, art. 5, Sch. para. 1(3) (with art. 4)F11Words in s. 5(2) repealed (27.3.2002) by S.I. 2002/794, art. 5(2), Sch. 2 (with art. 6)Modifications etc. (not altering text)C22Pt. I(ss. 1–5) extended by S.I. 1984/187, art. 2Part IIE+W+S+N.I. Licences and Certificates Relating to Medicinal Products General provisions and exemptionsE+W+S+N.I.6 The licensing authority. E+W+S+N.I.(1)For the purposes of this Part of this Act the authority responsible for the grant, renewal, variation, suspension and revocation of licences and certificates shall be a body of Ministers consisting of all the Ministers specified in paragraphs (a) and (b) of section 1(1) of this Act.
(2)Any function conferred on the licensing authority by or under this Act may be performed by any one of those Ministers acting alone or by any two or more of them acting jointly.
(3)In accordance with the preceding provisions of this section, in this Act “the licensing authority” means any one or more of those Ministers, and, in the case of anything falling to be done by the licensing authority, means any one or more of those Ministers acting as mentioned in subsection (2) of this section.
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Modifications etc. (not altering text)C23Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)C24S. 6 applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2),Sch.S. 6 extended (with modifications) (14.2.1994) by S.I. 1994/105, reg. 19, Sch.47 General provisions as to dealing with medicinal products. E+W+S+N.I.(1)The following provisions of this section shall have effect subject to—
(a)any exemption conferred by or under this Part of this Act;
(b)the provisions of this Part of this Act relating to clinical trials and medicinal tests on animals; and
(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.
[F12(2A)The restrictions imposed by subsection (2) of this section shall not apply where the medicinal product concerned is a homoeopathic medicinal product in respect of which a certificate of registration has been granted.
(2B)In relation to a homoeopathic medicinal product to which the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 F13 apply but in respect of which no certificate of registration has been granted, the references in subsection (2) of this section to the activities of sale or supply and of procuring the sale or supply respectively shall be taken to include references to any activity which amounts to placing such a product on the market within the meaning of Council Directive 92/73/EEC F14 of 22 September 1992.]
(3)No person shall import any medicinal product except in accordance with a product licence.
(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,
[F15(a)is responsible for the composition of the product, or
[F16(b)if that product is a proprietary medicinal product [F17, a ready-made veterinary drug or an industrially produced medicinal product other than a veterinary drug], 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.
[F18(6A)Where the product which a person is responsible for placing on the market in the United Kingdom is not a veterinary drug, subsection (5)(b) of this section shall not apply if the product is—
(a)whole human blood, human blood plasma or blood cells of human origin, [F19or]
(b)a radiopharmaceutical in which the radionuclide is in the form of a sealed source, F20. . .
F20(c). . .
(6B)Where the product which a person is responsible for placing on the market in the United Kingdom is a veterinary drug, subsection (5)(b) of this section shall not apply if the product is—
(a)a vaccine, toxin or serum,
(b)a product based on radioactive isotopes,
(c)a product specially prepared for administration by a veterinary surgeon or veterinary practitioner to a particular animal or herd which is under his care,
(d)a homoeopathic medicinal product, or
(e)an additive for animal feeding stuffs to which the provisions of Council Directive 70/524/EEC apply.]
[F22In this section—
[F23“certificate of registration" means a certificate granted under the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994;
“homoeopathic medicinal product" means any medicinal product (which may contain a number of principles) prepared from products, substances or compositions 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; and]
“ready-made veterinary drug” means a ready-prepared veterinary drug placed on the market in the United Kingdom in a pharmaceutical form in which it may be used without further processing, not being a drug placed on the market under a special name and in a special pack; F24. . .]
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Amendments (Textual)F12S. 7(2A)(2B) inserted (13.2.1994) by S.I. 1994/276, reg. 3(2) (which S.I. revoked and replaced defective S.I. 1994/101 before the latter S.I. came into force)F13S.I. 1994/105.F14OJ No. L 297, 13.10.92, p. 8.F15Words substituted by (E.W.)(S.) S.I. 1977/1050, art. 2(2) and (N.I.) S.R. 1977 No. 170, reg. 3F16S. 7(5)(b) substituted by S.I. 1983/1724, art. 2(2)F17Words in S. 7(5)(b) substituted (3.4.1992) by S.I. 1992/604, regs. 2(2), 4F18S. 7(6A)(6B) inserted (3.4.1992) by S.I. 1992/604, regs. 2(3), 4F19Word inserted (13.2.1994) in s. 7(6A) at the end of (a) by S.I. 1994/276, reg. 3(3)(a) (which S.I. revoked and replaced defective S.I. 1994/101 before the latter S.I. came into force)F20In 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)F21S. 7(7) substituted by S.I. 1983/1724, art. 2(3)F22Words in s. 7(7) substituted (3.4.1992) by S.I. 1992/604, regs. 2(4), 4F23Definitions 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)F24Words in s. 7(7) repealed (3.4.1992) by S.I. 1992/604, regs. 2(5), 4Modifications etc. (not altering text)C25Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)C26S. 7 excluded by S.I. 1989/2325, art. 2(1)C27S. 7 excluded (11.12.1992) by S.I. 1992/2844, art. 2S. 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)C28S.7 excluded by S.I. 1981/164, art. 3C29S. 7(1)(a)(2)(4)(5)(6) applied (with modifications) (3.4.1992) by S.I. 1992/605, reg. 2(1)(2), Sch.8 Provisions as to manufacture and wholesale dealing. E+W+S+N.I.(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 (a) to (c) of subsection (1) of that section.
(2)No person shall, in the course of a business carried on by him, manufacture or assemble 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”).
[F25(3)[F26Subject to subsection (3C) 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 [F27, ready-made veterinary drug or industrially produced medicinal product other than a veterinary drug] which has been imported, but was not consigned from a member State,
except in accordance with a [F28wholesale dealer’s licence].]
[F29(3A)Without prejudice to the generality of subsection (3) of this section but subject to subsection (3C), no person shall, in the course of a business carried on by him, distribute by way of wholesale dealing a product to which [F30the 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 [F30the 2001 Directive applies] apply by the holder of a manufacturer’s licence in respect of it.]
[F31(4)Where the product which a person distributes is not a veterinary drug, subsection (3)(b) of this section shall not apply if the product is—
(a)whole human blood, human blood plasma or blood cells of human origin, [F32or]
(b)a radiopharmaceutical in which the radionuclide is in the form of a sealed source, [F33. . .]
F33(c). . .
(5)Where the product which a person distributes is a veterinary drug, subsection (3)(b) of this section shall not apply if the product is—
(e)an additive for animal feeding stuffs to which the provisions of Council Directive 70/524/EEC apply.
(6)In this section, [F34homoeopathic medicinal product,]“proprietary medicinal product”, “radiopharmaceutical” and “ready-made veterinary drug” have the same meanings as in section 7 of this Act.]
[F35(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.]
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Amendments (Textual)F25S. 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. 4F26Words in s. 8(3) inserted (14.4.1993) by S.I. 1993/834, reg. 2(2)F27Words in s. 8(3)(b) substituted (3.4.1992) by virtue of S.I.1992/604, regs. 3(2), 4F28Words in s. 8(3) substituted (14.4.1993) by S.I. 1993/834, reg. 2(3)F29S. 8(3A)-(3C) inserted (14.4.1993) by S.I. 1993/834, reg. 2(4)F30Words in s. 8(3A)(3C) substituted (28.2.2002) by S.I. 2002/236, reg. 2(a)(i)F31S. 8(4)(5)(6) substituted (3.4.1992) for s. 8(4) by virtue of S.I. 1992/604, regs. 3(3), 4F32Word in s. 8(4) inserted (13.2.1994) at the end of para.(a) by S.I. 1994/276, reg. 4(2)(a)( which S.I. revoked and replaced defective S.I. 1994/101, before the later S.I. came into force)F33In 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)F34Words 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)F35S. 8(7)(8) added (14.4.1993) by S.I. 1993/834, reg. 2(5)Modifications etc. (not altering text)C30Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)C31S. 8 excluded by S.I. 1989/2325, art. 2(3)C32S. 8(2) excluded by S.I. 1979/1114, arts. 2, 4 and by S.I. 1979/1585, arts. 2, 3C33S. 8(3) excluded by S.I. 1989/2322, art. 2(1)C34S. 8(3) excluded by S.I. 1990/566, art. 2(1)C35S. 8(3)(b) excluded by S.I. 1989/2322, art. 2(3)C36S. 8(3)(b) excluded by S.I. 1990/566, art. 2(3)9 Exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners. E+W+S+N.I.(1)The restrictions imposed by sections 7 and 8 of this Act do not apply to anything done by a doctor or dentist which—
(a)relates to a medicinal product specially prepared, or specially imported by him or to his order, for administration to a particular patient of his, and consists of manufacturing or assembling, or procuring the manufacture or assembly of, the product, or of selling or supplying, or procuring the sale or supply of, the product to that patient or to a person under whose care that patient is, or
(b)relates to a medicinal product specially prepared at the request of another doctor or dentist, or specially imported by him or to his order at the request of another doctor or dentist, for administration to a particular patient of that other doctor or dentist, and consists of manufacturing or assembling, or procuring the manufacture or assembly of, the product, or of selling or supplying, or procuring the sale or supply of, the product to that other doctor or dentist or to that patient or to a person under whose care that patient is.
(2)Subject to subsection (3) of this section, the restrictions imposed by sections 7 and 8 of this Act do not apply to anything done by a veterinary surgeon or veterinary practitioner which—
(a)relates to a medicinal product specially prepared for administration to a particular animal or herd which is under his care, and consists of manufacturing or assembling, or procuring the manufacture or assembly of, the product, or of selling or supplying, or procuring the sale or supply of, the product to a person having the possession or control of that animal or herd, or
(b)relates to a medicinal product specially prepared at the request of another veterinary surgeon or veterinary practitioner for administration to a particular animal or herd which is under the care of that other veterinary surgeon or veterinary practitioner, and consists of manufacturing or assembling, or procuring the manufacture or assembly of, the product, or of selling or supplying, or procuring the sale or supply of, the product to that other veterinary surgeon or veterinary practitioner or to a person having the possession or control of that animal or herd.
(3)The last preceding subsection shall not have effect so as to exempt from the restrictions imposed by sections 7 and 8 of this Act anything done by a veterinary surgeon or veterinary practitioner—
(a)in relation to a vaccine specially prepared for administration to poultry, or
(b)in relation to any other vaccine, unless the vaccine is specially prepared for administration to the animal from which it is derived, or
(c)in relation to plasma or a serum, unless the plasma or serum is specially prepared for administration to one or more animals in the herd from which it is derived [F36or
(d)in relation to a ready-made veterinary medicinal product as defined in Article 1.2 of the 1981 Directive.]
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Amendments (Textual)F36S. 9(3)(d) and preceding word inserted (31.12.1994) by S.I. 1994/2987, reg. 10(2)Modifications etc. (not altering text)C37Pt. II(ss. 6–50) extended with modifications by S.I. 1985/1403, art. 3(1)C38S. 9(2) restricted by S.I. 1987/2217, art. 310 Exemptions for pharmacists. E+W+S+N.I.(1)Subject to the next following subsection, the restrictions imposed by sections 7 and 8 of this Act do not apply to anything which is done in a registered pharmacy, a hospital [F37, 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 a practitioner, or
(b)assembling a medicinal product [F38provided 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.
(2)The exemption conferred by the preceding subsection does not apply to a vaccine specially prepared for administration to poultry, and does not apply to any other vaccine or any plasma or serum prepared or dispensed for administration to an animal or herd unless—
(a)in the case of a vaccine, it is specially prepared for administration to the animal from which it is derived, or
(b)in the case of plasma or a serum, it is specially prepared for administration to one or more animals in the herd from which it is derived,
and (in either case) it is so prepared in accordance with a prescription given by a veterinary surgeon or veterinary practitioner.
(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 [F39provided 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.
[F40(5)Without prejudice to the preceding subsections, the restrictions imposed by section 7 of this Act 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 section 8(2) of this Act 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.
[F41(6A)The preceding provisions of this section shall not have effect so as to exempt from the restrictions imposed by sections 7 and 8 of this Act anything done in a registered pharmacy by or under the supervision of a pharmacist in relation to a ready-made veterinary medicinal product as defined in Article 1.2 of the 1981 Directive.]
(7)Without prejudice to the preceding subsections, the restrictions imposed by section 8(3) [F42or (3A)] of this Act do not apply to anything which is done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than an inconsiderable part of the business carried on by the pharmacist at that pharmacy.
(8)For the purposes of this section “advertisement" shall have the meaning assigned to it by section 92 of this Act, except that it shall not include words inscribed on the medicinal product, or on its container or package.]
[F43(9)In subsection (1) of this section, “care home service" has the meaning given by section 2(3) of the Regulation of Care (Scotland) Act 2001 (asp 8).]
Annotations:Annotations are used to give authority for changes and other effects on the legislation you are viewing and to convey editorial information. They appear at the foot of the relevant provision or under the associated heading. Annotations are categorised by annotation type, such as F-notes for textual amendments and I-notes for commencement information (a full list can be found in the Editorial Practice Guide). Each annotation is identified by a sequential reference number. For F-notes, M-notes and X-notes, the number also appears in bold superscript at the relevant location in the text. All annotations contain links to the affecting legislation.Amendments (Textual)F37Words 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)F38Words added by S.I. 1971/1445, art. 3(a)F39Words added by S.I. 1971/1445, art. 3(b)F40S. 10(5)–(8) added by S.I. 1971/1445, art. 3(c)F41S. 10(6A) inserted (31.12.1994) by S.I. 1994/2987, reg. 11(2)F42Words in s. 10(7) inserted (14.4.1993) by S.I. 1993/834, reg. 3F43