| Act of Parliament | |
 | |
| Long title | An Act to make new provision with respect to medicinal products and related matters, and for purposes connected therewith. |
|---|---|
| Citation | 1968 c. 67 |
| Territorial extent | United Kingdom |
| Dates | |
| Royal assent | 25 October 1968 |
| Commencement | 1968 |
Status: Amended | |
| Text of the Medicines Act 1968 as in force today (including any amendments) within the United Kingdom, from legislation.gov.uk. | |
The Medicines Act 1968 (c. 67) is an act of Parliament of the United Kingdom. Its official long title is "An Act to make new provision with respect to medicinal products and related matters, and for purposes connected therewith."[1] It governs the control of medicines for human use and for veterinary use, which includes the manufacture and supply of medicines, and the manufacture and supply of (medicated) animal feeding stuffs.[2]
The act defines three categories of medicine: prescription only medicines (POM),[3] which are available only from a pharmacist if prescribed by an appropriate practitioner (including, but not limited to doctors, dentists, optometrists, prescribing pharmacists and nurses); pharmacy medicines (P), available only from a pharmacist but without a prescription; and general sales list (GSL) medicines which may be bought from any shop without a prescription.
The act controls supply of the drugs it covers, but does not define any offence of simple possession. Possession of a prescription only drug without a prescription is only an offence if the drug is also controlled under the Misuse of Drugs Act 1971 and possession is thus specified as an offence. Therefore, for example, possession of a prescription only antibiotic without a prescription is not an offence.
For description of the legal classification of medicines in the UK see the Royal Pharmaceutical Society web site, and the publication Medicines Ethics and Practice.[4]
The act was introduced following problems with the off-label use of thalidomide.[5][6][7][8]
The act established the forerunner to the actual Commission on Human Medicines.
- ^ "Medicines Act 1968". www.Legislation.gov.uk. Her Majesty's Government of the United Kingdom. Retrieved 7 November 2016.
- ^ Kayne, Steven B; Jepson, Michael H, eds. (2004). Veterinary Pharmacy. Pharmaceutical Press.
- ^ "The Prescription Only Medicines (Human Use) Order 1997". www.Legislation.gov.uk. Her Majesty's Government of the United Kingdom. Retrieved 7 November 2016.
- ^ http://www.rpharms.com/mep/legal-classification-of-medicines.asp (subscription required)
- ^ Conroy, S.; McIntyre, J.; Choonara, I.; HULL, P. S. D. (1 March 1999). "Unlicensed and off label drug use in neonates Commentary". Archives of Disease in Childhood: Fetal and Neonatal Edition. 80 (2): F142–F145. doi:10.1136/fn.80.2.F142. PMC 1720896. PMID 10325794.
- ^ Royal Pharmaceutical Society (2011). "The evolution of pharmacy, Theme E, Level 3 Thalidomide and its aftermath" (PDF). Archived from the original (PDF) on 9 October 2014.
- ^ Griffin, J. P. (1998). "The evolution of human medicines control from a national to an international perspective". Adverse Drug Reactions and Toxicological Reviews. 17 (1): 19–50. PMID 9638280.
- ^ Shah, R. R. (2001). "Thalidomide, drug safety and early drug regulation in the UK". Adverse Drug Reactions and Toxicological Reviews. 20 (4): 199–255. PMID 11770171.