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