DOCSLIB.ORG

The Medicines Act 1968 Amended

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
The Medicines Act 1968 Amended 1 Medicines Act 1968 (c.67) Warning: This content may not be up-to-date. Please check the Update Status Warning message at the top of the Results within Legislation page Medicines Act 1968 1968 c.67 An Act to make new provision with respect to medicinal products and related matters, and for purposes connected therewith. The Medicines Act 1968 does not apply in relation to veterinary medicinal products. The Medicines (Prohibition of Importation and Possession of Veterinary Drugs Order (Northern Ireland) 1977 continues in force notwithstanding, and the Medicines Act 1968 shall continue to apply in so far as is necessary for the operation of that Order 25th October 1968 Medicines Act 1968 ......................................................................................................................................... 1 Part I ........................................................................................................................................................ 6 Administration .................................................................................................................................... 6 1. Ministers responsible for administration of Act ...................................................................... 6 2. …. ............................................................................................................................................ 6 2A. Establishment of the Commission on Human Medicines ..................................................... 6 3. Functions of the Commission .................................................................................................. 6 4. Establishment of committees. .................................................................................................. 6 5. Supplementary provisions as to Commission and committees. .............................................. 7 PART II ................................................................................................................................................... 7 Licences and certificates relating to medicinal products ............................................................ 7 General provisions and exceptions ............................................................................................ 7 6. The licensing authority. ........................................................................................................... 7 7. General provisions as to dealing with medicinal products. ............................................ 7 8. Provisions as to manufacture and wholesale dealing. ............................................................. 8 9. Exemptions for doctors and dentists ….. ................................................................................ 9 10. Exemptions for pharmacists. ................................................................................................. 9 11. Exemption for nurses and midwives. .................................................................................. 10 12. Exemptions in respect of herbal remedies. .......................................................................... 10 13. Exemptions for imports. ...................................................................................................... 11 14. Exemption for re-exports. .................................................................................................... 11 15. Provision for extending or modifying exemptions. ............................................................. 11 16. Transitional exemptions. ..................................................................................................... 11 17. Termination of transitional exemptions. ............................................................................. 12 Applications for, and grant and renewal of, licences ............................................................ 12 18. Application for licence. ....................................................................................................... 12 19. Factors relevant to determination of application for licence. .............................................. 12 20. Grant or refusal of licence. .................................................................................................. 13 21. Procedure on reference to appropriate committee. .............................................................. 13 22. Procedure in other cases. ............................................................................................... 14 22A. Hearing before person appointed ...................................................................................... 14 23. Special provisions as to effect of manufacturer’s licence. .................................................. 15 24. Duration and renewal of licence. ......................................................................................... 15 Licences of right .......................................................................................................................... 16 25. Entitlement to licence of right. ............................................................................................ 16 26. Scope of licence of right in different cases. ........................................................................ 16 27. Proceedings on application for licence of right. .................................................................. 16 Suspension, revocation and variation of licences ................................................................. 17 28. General power to suspend, revoke or vary licences. ........................................................... 17 29. Procedure where licensing authority propose to suspend, revoke or vary licence under s. 28. .............................................................................................................................................. 18 30. Variation of licence on application of holder. ..................................................................... 18 Clinical trials and medicinal tests on animals ......................................................................... 18 31. ……… ................................................................................................................................ 18 32. … ......................................................................................................................................... 18 33. ... .......................................................................................................................................... 18 34. ... ......................................................................................................................................... 18 35. ... .......................................................................................................................................... 18 36. ... .......................................................................................................................................... 18 2 Medicines Act 1968 (c.67) 37. Transitional provisions as to clinical trials and medicinal tests on animals. ....................... 18 38. ... .......................................................................................................................................... 19 39. ... ............................................................................................................................................. 19 40. ... .......................................................................................................................................... 19 41. … ......................................................................................................................................... 19 42. … ......................................................................................................................................... 19 Supplementary provisions ......................................................................................................... 19 43. Extension of s. 7 to certain special circumstances. ............................................................. 19 44. Provision of information to licensing authority. ................................................................. 19 45. Offences under Part II. ........................................................................................................ 20 46. Special defences under s. 45. ............................................................................................... 20 47. Standard provisions for licences …. .................................................................................... 21 48. Postponement of restrictions in relation to exports. ............................................................ 21 49. Special provisions in respect of exporting certain products. ............................................... 22 49A. Special provisions in respect of exporting certain products to member States, ............... 23 50. Certificates for exporters of medicinal products. ................................................................ 23 Part III .................................................................................................................................................... 23 Further provisions relating to dealings with medicinal products .............................................. 23 Provisions as to sale or supply of medicinal products .........................................................
Load more

Recommended publications
  • MEDICINES ACT 2003 Chapter 4
    © Copyright Treasury of the Isle of Man Crown Copyright reserved See introductory page for restrictions on copying and reproduction MEDICINES ACT 2003 Chapter 4 Arrangement of sections PART 1 DEALINGS WITH MEDICINAL PRODUCTS 1. Introductory. 2. Restrictions on dealing with medicinal products. 3. Exemptions. 4. General sale of medicinal products. 5. Medicinal products on prescription only. 6. Regulations: general provisions. PART 2 CONSUMER PROTECTION 7. Adulteration of medicinal products. 8. Protection of purchasers of medicinal products. 9. Compliance with published standards. 10. Misleading descriptions etc. 11. Display of information on automatic machines. 12. Offences. PART 3 PROMOTION OF SALES OF MEDICINAL PRODUCTS 13. False or misleading advertisements and representations. 14. Advertisements requiring consent. 15. Regulation of advertisements and representations. 16. Advertisements and representations directed to practitioners. 17. Interpretation. PART 4 ENFORCEMENT 18. Enforcement etc. 19. Rights of entry. 20. Power to inspect, take samples and seize goods and records. 1 Medicines Act 2003 21. Application of sampling procedure to substance or article seized under s. 20. 22. Obstruction etc. 23. Analysis of samples in other cases. 24. Liability to forfeiture. 25. Restrictions on disclosure of information. 26. Contravention due to default of other person. 27. Warranty as defence. 28. Offences in relation to warranties and certificates of analysis. 29. Offences: general. 30. Presumptions. PART 5 VETERINARY MEDICINAL PRODUCTS AND ANIMAL FEEDING STUFFS 31. Veterinary medicinal products. 32. Application of Parts 1 to 4 to veterinary medicinal products. 33. Medicated animal feeding stuffs. 34. Animal feeding stuffs: enforcement. PART 6 PHARMACIES Conduct of retail pharmacy business 35. Retail pharmacy business. 36.
    [Show full text]
  • Resolving the Inconsistency Between National and EU Motor Insurance Law
    CORE Metadata, citation and similar papers at core.ac.uk Provided by Repository@Nottingham Resolving the Inconsistency between National and EU Motor Insurance Law. Was Factortame the Solution nobody Sought? Abstract In this article we argue that the continued uncertainty of UK national motor vehicle insurance law when viewed in respect of its EU parent, the Motor Vehicle Insurance Directive (MVID), has not been satisfactorily addressed using the remedy available through the non-contractual liability of the State. The existing enforcement mechanisms have equally been haphazard in their effectiveness and success in affording rights to third-party victims. Given the link between the MVID and the free movement of persons and goods on which the harmonization of insurance protection was based, we present the first article establishing an argument for the offending aspects of UK national law to be disapplied. Whilst the UK has concluded its agreement to withdraw its membership from the EU and thus to be bound by EU law and the jurisprudence of the Court of Justice, until the transitional period is completed the UK remains aligned to EU law. It is committed to follow superior EU law and the judgments of the Court of Justice. Hence the remedy issued from the Factortame line of case authorities may prove to be the most effective way to grant access to rights which continue to be denied to victims in the UK. KEYWORDS: Breach of EU law; Factortame; Francovich v Italy; HS2; motor vehicles; MVID. A. Introduction As is well understood, the European Union, in its present and previous incarnations, was designed to facilitate a common market between its Member States (similar to a domestic market).
    [Show full text]
  • Medicines Act 1968 Is up to Date with All Changes Known to Be in Force on Or Before 19 July 2021
    Status: Point in time view as at 19/01/2010. Changes to legislation: Medicines Act 1968 is up to date with all changes known to be in force on or before 19 July 2021. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations. (See end of Document for details) 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] 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.
    [Show full text]
  • Medicines Act 1968
    Changes 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. (See end of Document for details) ELIZABETH II c. 67 Medicines Act 1968 1968 CHAPTER 67 AnAct 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.
    [Show full text]
  • The Law Commission and the Scottish Law Commission (LAW COM
    The Law Commission and The Scottish Law Commission (LAW COM. No. 21) (SCOT. LAW COM. No. 11) THE WTERPRETATION OF STATUTE§ Laid before Parliament by the Lord High Chancellor, the Secretary of State for Scotland and the Lord Advocate pursuant to section 3(2) of the Law Commissions Act 1965 Ordered by The House of Commons to be printed 9th June 1969 LONDON HER MAJESTY’S STATIONERY OFFICE Reprinted 1 9 7 4 256 4Op net The Law Commission was set up by section 1 of the Law Commissions Act 1965 for the purpose of promoting the reform of the law other than the law of Scotland or of any law of Northern Ireland which the Parliament of Northern Ireland has power to amend. The Commissioners are: The Honourable Mr. Justice Scarman, O.B.E., Chairman. Mr. L. C. B. Gower. Mr. Neil Lawson, Q.C. Mr. Norman S. Marsh, Q.C. Mr. Andrew Martin, Q.C. Mr. Arthur Stapleton Cotton is a special consultant to the Commission. The Secretary of the Commission is Mr. J. M. Cartwright Sharp, and its offices are at Lacon House, Theobald’s Road, London, W.C.l. The Scottish Law Commission was set up by section 2 of the Law Com- missions Act 1965 for the purpose of promoting the reform of the Law of Scotland. The Commissioners are: The Honourable Lord Kilbrandon, Chairman. Professor A. E. Anton. Professor J. M. Halliday. Mr. A. M. Johnston, Q.C. Professor T. B. Smith, Q.C. I The Secretary of the Commission is Mr. A. G.
    [Show full text]
  • The Human Medicines Regulations 2012
    STATUTORY INSTRUMENTS 2012 No. 1916 MEDICINES The Human Medicines Regulations 2012 Made - - - - 19th July 2012 Laid before Parliament 24th July 2012 Coming into force - - 14th August 2012 £38.00 STATUTORY INSTRUMENTS 2012 No. 1916 MEDICINES The Human Medicines Regulations 2012 Made - - - - 19th July 2012 Laid before Parliament 24th July 2012 Coming into force - - 14th August 2012 CONTENTS PART 1 General 1. Citation and commencement 14 2. Medicinal products 14 3. Scope of these Regulations: special provisions 15 4. Special provisions for pharmacies etc 16 5. Classification of medicinal products 17 6. The licensing authority and the Ministers 18 7. Advertisements relating to medicinal products 18 8. General interpretation 19 PART 2 Administration 9. Commission on Human Medicines 30 10. Functions of the Commission 30 11. British Pharmacopoeia Commission 30 12. Reporting to Ministers 31 13. Co-option of additional members of advisory bodies 31 14. Appointment of expert advisory groups 31 15. Delegation of functions to expert advisory groups 31 16. Further provision about advisory bodies and expert advisory groups etc 32 PART 3 Manufacturing and wholesale dealing Grant etc of licences 17. Manufacturing of medicinal products 32 18. Wholesale dealing in medicinal products 32 19. Exemptions from requirement for wholesale dealer’s licence 33 20. Mixing of medicines 34 21. Application for manufacturer’s or wholesale dealer’s licence 34 22. Factors relevant to determination of application for manufacturer’s or wholesale dealer’s licence 34 23. Grant or refusal of licence 35 24. Standard provisions of licences 35 25. Duration of licence 35 26. General power to suspend, revoke or vary licences 36 27.
    [Show full text]
  • Post-Legislative Assessment of Health Act 2006
    Post-Legislative Assessment of the Health Act 2006 Memorandum to the Health Committee of the House of Commons Post-Legislative Assessment of the Health Act 2006 Presented to Parliament by the Secretary of State for Health by Command of Her Majesty July 2011 Cm 8115 £8.50 © Crown copyright 2011 You may re-use this information (excluding logos) free of charge in any format or medium, under the terms of the Open Government Licence. To view this licence, visit www.nationalarchives.gov.uk/doc/open-government­ licence/ or e-mail: [email protected]. Where we have identified any third party copyright information, you will need to obtain permission from the copyright holders concerned. Any enquiries regarding this publication should be sent to us at Customer Service Centre, Department of Health, Richmond House, 79 Whitehall, London SW1A 2NS. This publication is available for download at www.official-documents.gov.uk This document is also available from our website at www.dh.gov.uk/en/Publicationsandstatistics/index.htm ISBN: 978-0-101-81152-1 Printed in the UK for The Stationery Office Limited on behalf of the Controller of Her Majesty’s Stationery Office ID 2441746 07/11 Printed on paper containing 75% recycled fibre content minimum 406904 Contents Introduction 2 Objectives of the Health Act 2006 2 Other post-legislative reviews 3 Preliminary assessment of the effect of key elements of the Health Act 2006 5 Impact assessment and equality analysis 5 Smoke-free law 5 Age of sale of tobacco products 7 Prevention and control of healthcare-associated infections 8 Supervision of management and use of controlled drugs 9 Responsible pharmacist and supervision 10 Provision of NHS pharmaceutical services 12 Provision of primary ophthalmic services 13 Countering fraud and other unlawful activities against the NHS 14 Auditing of the accounts of certain NHS bodies 15 Appointments Commission 15 Injury cost recovery in the NHS 16 Conclusion 18 1 Introduction 1.
    [Show full text]
  • Legislating for Brexit: Statutory Instruments Implementing EU Law
    ` BRIEFING PAPER Number 7867, 16 January 2017 Legislating for Brexit: Statutory By Vaughne Miller Instruments implementing EU law Contents: 1. Introduction 2. EU law in the UK 3. Appendix List of SIs www.parliament.uk/commons-library | intranet.parliament.uk/commons-library | [email protected] | @commonslibrary 2 Legislating for Brexit: Statutory Instruments implementing EU law Contents Summary 4 1. Introduction 6 2. EU law in the UK 7 2.1 How are SIs to implement EU laws adopted? 7 2.1 Do the devolved Administrations adopt EU law? 8 2.2 Where can I find EU-related SIs? 8 3. Appendix List of SIs 9 3 Commons Library Briefing, 16 January 2017 Contributing Authors: Sasha Gorb Cover page image copyright EU flag, British flag and Palace of Westminster – CC0 Public domain: no attribution required. All images cropped. 4 Legislating for Brexit: Statutory Instruments implementing EU law Summary According to data on the EU’s Eur-Lex database, there are at present around 19,000 EU legislative acts in force. These are mainly directives, regulations, decisions and external agreements, but they include a range of other instruments. As Commons Briefing Paper Legislating for Brexit: the Great Repeal Bill, CBP7793, 21 November 2016, explains, a major issue for Brexit is what to do about EU legislation that has been incorporated into UK law. Section 2(2) of the European Communities Act 1972 (ECA) provides a power for subordinate legislation to be made where the EU Treaties require Member States to make provisions in their domestic law, such as for the implementation of EU directives.
    [Show full text]
  • Statutory Instrument 2005 No. 765
    Statutory Instrument 2005 No. 765 The Medicines for Human Use (Prescribing) Order 2005 © Crown Copyright 2005 Statutory Instruments printed from this website are printed under the superintendence and authority of the Controller of HMSO being the Queen's Printer of Acts of Parliament. The legislation contained on this web site is subject to Crown Copyright protection. It may be reproduced free of charge provided that it is reproduced accurately and that the source and copyright status of the material is made evident to users. It should be noted that the right to reproduce the text of Statutory Instruments does not extend to the Queen's Printer imprints which should be removed from any copies of the Statutory Instrument which are issued or made available to the public. This includes reproduction of the Statutory Instrument on the Internet and on intranet sites. The Royal Arms may be reproduced only where they are an integral part of the original document. The text of this Internet version of the Statutory Instrument which is published by the Queen's Printer of Acts of Parliament has been prepared to reflect the text as it was Made. A print version is also available and is published by The Stationery Office Limited as the The Medicines for Human Use (Prescribing) Order 2005, ISBN 0110725654. The print version may be purchased by clicking here. Braille copies of this Statutory Instrument can also be purchased at the same price as the print edition by contacting TSO Customer Services on 0870 600 5522 or e-mail: [email protected].
    [Show full text]
  • House of Lords Official Report
    Vol. 731 Wednesday No. 207 19 October 2011 PARLIAMENTARY DEBATES (HANSARD) HOUSE OF LORDS OFFICIAL REPORT ORDER OF BUSINESS Questions Health: Obesity Public Services: Security of Provision Industrial Tribunals: Fees Nursing: Elderly and Vulnerable Patients Scrap Metal Dealers (Amendment) Bill First Reading Medicines Act 1968 (Pharmacy) Order 2011 Motion to Approve Electricity and Gas (Internal Markets) Regulations 2011 Motion to Approve Terrorism Prevention and Investigation Measures Bill Committee (1st Day) Northern Ireland: Economy Question for Short Debate Written Statements Written Answers For column numbers see back page £3·50 Lords wishing to be supplied with these Daily Reports should give notice to this effect to the Printed Paper Office. The bound volumes also will be sent to those Peers who similarly notify their wish to receive them. No proofs of Daily Reports are provided. Corrections for the bound volume which Lords wish to suggest to the report of their speeches should be clearly indicated in a copy of the Daily Report, which, with the column numbers concerned shown on the front cover, should be sent to the Editor of Debates, House of Lords, within 14 days of the date of the Daily Report. This issue of the Official Report is also available on the Internet at www.publications.parliament.uk/pa/ld201011/ldhansrd/index/111019.html PRICES AND SUBSCRIPTION RATES DAILY PARTS Single copies: Commons, £5; Lords £3·50 Annual subscriptions: Commons, £865; Lords £525 WEEKLY HANSARD Single copies: Commons, £12; Lords £6 Annual subscriptions: Commons, £440; Lords £255 Index: Annual subscriptions: Commons, £125; Lords, £65. LORDS VOLUME INDEX obtainable on standing order only.
    [Show full text]
  • Misuse of Drugs Act 1971 CHAPTER 38 As Amended (Apart from SI 1975
    Misuse of Drugs Act 1971 CHAPTER 38 As amended (apart from SI 1975/421(no longer available)) First Published 1971 Reprinted 2003 £7.25 c. 38 Misuse of Drugs Act 1971 i Misuse of Drugs Act 1971 CHAPTER 38 ARRANGEMENT OF SECTIONS THE ADVISORY COUNCIL ON THE MISUSE OF DRUGS ................................................................................. 1 1. The Advisory Council on the Misuse of Drugs .......................................................................... 1 CONTROLLED DRUGS AND THEIR CLASSIFICATION ...................................................................................... 2 2. Controlled drugs and their classification for purposes of this Act ............................................. 2 RESTRICTIONS RELATING TO CONTROLLED DRUGS ETC. ............................................................................. 2 3. Restriction of importation and exportation of controlled drugs .................................................. 2 4. Restriction of production and supply of controlled drugs .......................................................... 2 4A Aggravation of offence of supply of controlled drug .................................................................... 3 5. Restriction of possession of controlled drugs ........................................................................... 3 6. Restriction of cultivation of cannabis plant ................................................................................ 4 7. Authorisation of activities otherwise unlawful under foregoing provisions ...............................
    [Show full text]
  • Thesis Is Submitted in Partial Fulfillment of the Requirements of Cardiff Metropolitan University for the Award of the Degree of Phd by Research
    A Critique of Trading Standards in Wales – Post-devolution Developments and Prognosis Huw David Evans LLB, Solicitor (non-practising), PGCE (PCET) This thesis is submitted in partial fulfillment of the requirements of Cardiff Metropolitan University for the award of the Degree of PhD by Research July 2020 Supervised by Dr Alan Sandry (Director of Studies), Dr Vitti Allender and Dr Ruth Fairchild Acknowledgements Thank you to those who participated in the study. I am indebted to everyone for their contributions. It never failed to surprise me how willing people were to share their time and knowledge. I am also indebted to my Director of Studies, Dr Alan Sandry, and to my other supervisors, Dr Vitti Allender and Dr Ruth Fairchild, for their enthusiasm, guidance and wise counsel throughout. They have been immensely supportive. I must also acknowledge Dr Sandry’s excellent overall supervision of the project. Thanks also to work colleagues who have been unfailingly supportive in helping me manage my PhD effort while balancing that with ‘day job’ commitments. I am particularly grateful to Dr Lalage Sanders who, as Graduate Studies Coordinator, was extremely helpful in getting things started. Finally, and in no way least, I extend my gratitude to my wife, Christine, and children, Jonathan, Rebeca and Steffan, for their on-going support (and good-humoured tolerance) throughout my period of study. This has been greatly appreciated. Without it, I am not sure I would have completed this thesis. ii Abstract This thesis investigates and critically evaluates Trading Standards (TS) delivery in Wales. TS enforces law to promote fair trading.
    [Show full text]