Medicines Act 1968

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The Medicines Act 1968 (c. 67) is an act of the 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 current Commission on Human Medicines.

Provisions

Repealed enactments

Section 135(2) of the act repealed 14 enactments, listed in the schedule 6 to the act.[9]

CitationShort titleExtent of repeal
7 & 8 Geo. 5. c. 21Venereal Disease Act 1917Section 2(2), except the proviso.
23 & 24 Geo. 5. c. 25Pharmacy and Poisons Act 1933Sections 8 to 14. In section 17, in subsection (2), the words 'of persons who are to be entitled to sell poisons in Part II', and, in subsection (6), the words from 'and in this Act' to the end of the subsection. In section 18(2)(a)(ii) the word "registered". Section 19. In section 23, in subsection (1), paragraph (a), paragraph (b)(ii) and paragraph (i); and in subsection (3), in the reference to paragraphs (a), (b)(i), (c), (d), (e) and (i), the references to paragraphs (a) and (i). In section 25, in subsection (1) the words 'Part I of this Act and of section nineteen and', in subsection (4) those words and the word 'registered', and subsection (9). In section 29, the definitions of 'authorised seller of poisons' and 'poison' and paragraph (a) of the definition of 'registered'.
2 & 3 Geo. 6. c. 13Cancer Act 1939In section 4, subsection (1)(b), subsection (3) and subsection (4)(a)(vii).
4 & 5 Geo. 6. c. 42Pharmacy and Medicines Act 1941The whole act.
11 & 12 Geo. 6. c. 37Radioactive Substances Act 1948Sections 3 and 4. In section 12, the definition of 'authorised seller of poisons'.
14 Geo. 6. c. 36Diseases of Animals Act 1950Part II and Schedule 3.
2 & 3 Eliz. 2. c. 61Pharmacy Act 1954Section 19.
4 & 5 Eliz. 2. c. 16Food and Drugs Act 1955In section 1, subsection (2) and subsection (3)(b). In section 2(3), the words from "except" to "drugs". Section 3(2). In section 6(6), the words from "except" to "drugs". In section 91(2), the words from "but" to the end of the subsection. In section 109(3)(a), the words from "so" to the end of the paragraph. In section 114(4), the words from 'the authority concerned' to 'in any other case'. The words "or drug" and "drug" wherever they occur, except in section 135. In Schedule 8, in column 2, in the first paragraph, the words from "other" to "drug". In Part I of Schedule 9, in column 2, paragraph (a)(iii) of the definition relating to sections 321 to 325 of the Public Health Act 1936.
4 & 5 Eliz. 2. c. 25Therapeutic Substances Act 1956The whole act.
4 & 5 Eliz. 2. c. 30Food and Drugs (Scotland) Act 1956In section 1, subsection (2) and subsection (3)(b). In section 2(3) the words from "except" to "drugs". Section 3(2). In section 6(6) the words from "except" to "drugs". In section 28(2) the words from "but" to the end of the subsection. The words "or drug" and "drug" wherever they occur, except in section 58.
4 & 5 Eliz. 2. c. 76Medical Act 1956Section 47. Section 57(9) and (10).
1963 c. 9Purchase Tax Act 1963In Part II of Schedule 1, in paragraph 5(2), the definition of 'authorised seller of poisons'.
1964 c. 64Drugs (Prevention of Misuse) Act 1964In section 1, in subsection (7), the reference to, and the paragraph substituted for, paragraph (k) of subsection (2). In section 9 the definition of 'authorised seller of poisons'.
1965 c. 15Dangerous Drugs Act 1965In section 11, in subsection (4) the words 'in subsection (1) thereof'.

Section 135(4) of the act repealed 8 enactments, listed in schedule 8 to the act.[10]

CitationShort titleExtent of repeal
15 & 16 Geo. 5. c. 8 (N.I.)Pharmacy and Poisons Act (Northern Ireland) 1925Section 17. Section 18. Schedule 3.
1945 c. 9 (N.I.)Medicines, Pharmacy and Poisons Act (Northern Ireland) 1945Part I. In section 14, in subsection (1) the words "if he is a registered person" and the words from "and, if he is a representative" onwards; and in subsection (2) the proviso. Sections 15 to 18. In section 19, in subsection (1) the words "or to be an authorised seller of poisons" and the words from ", or if the owner is a body corporate" to "employee of the body corporate,"; in subsection (2) in paragraph (a) the words from "or, if the owner" onwards and in paragraph (b) the words from "or, if the owner is a body corporate" to "employee of the body corporate,"; and subsection (3). In section 27(1)(a)(iii) the words from "in accordance" onwards. Section 28. In section 32, in subsection (1) paragraphs (a), (b)(ii) and (i), and in subsection (3) the references to paragraphs (a) and (i) of subsection (1). In section 35(3) the words "section four, section five or". In section 36(2) and (3) the words "I and". Section 37. In section 38(1) the definitions of "authorised seller of poisons", "poison", "premises having an annual licence" and "retailing". In Schedule 2 in the proviso to paragraph (1) the word "or" at the end of paragraph (a) and paragraphs (b) and (c).
1955 c. 31 (N.I.)Pharmacy and Poisons Act (Northern Ireland) 1955Section 2. Section 14.
1958 c. 13 (N.I.)Diseases of Animals Act (Northern Ireland) 1958Part II. In Schedule 4, Part I.
1958 c. 27 (N.I.)Food and Drugs Act (Northern Ireland) 1958In section 1 subsection (2), subsection (3)(b) and in subsection (6) the words "or drug". In section 2 in subsection (1) the words "or drug" in both places where they occur, and in subsection (3) the words ", except so far as it relates to drugs,". Section 3(2). In section 6 in subsection (1) the words "or drug" in each of the three places where they occur, in subsection (2) those words in each of the two places where they occur, in subsection (5) those words and in subsection (6) the words ", except so far as it relates to drugs,". In section 33 in subsection (2) the words "or drug" and subsection (3). In section 34 in subsection (1) the word ", drug" and in subsection (2) the words "or drug". In section 35 in subsections (1) and (4) the word ", drug". In section 38 the word ", drug" in both places where it occurs. In section 44 in subsection (2)(a) the word ", drug" in both places where it occurs and in subsection (3) that word in both places where it occurs. In section 47, in subsection (1) the words "so far as those sections or regulations relate to food", and in subsection (3)(a) the words "so far as it relates to food".
1966 c. 23 (N.I.)Diseases of Animals (Amendment) Act (Northern Ireland) 1966Section 3(2).
1967 c. 12 (N.I.)Pharmacy Act (Northern Ireland) 1967Section 5. In Schedule 1 the entries amending sections 17 and 27 of the Pharmacy and Poisons Act (Northern Ireland) 1925 and the entries amending the proviso to section 14(2) and sections 15, 16, 17 and 18 of, and paragraph 1 of Schedule 2 to, the Medicines, Pharmacy and Poisons Act (Northern Ireland) 1945.
1967 c. 29 (N.I.)Increase of Fines Act (Northern Ireland) 1967In the Schedule the entries relating to sections 15(4) and 16(1A) of the Medicines, Pharmacy and Poisons Act (Northern Ireland) 1945 and section 32 of the Diseases of Animals Act (Northern Ireland) 1958.

Notes

  1. ↑Section 136(1)
  2. ↑Section 136(2)
  3. ↑Section 136(3)–(4)

References

  1. ↑"Medicines Act 1968". www.Legislation.gov.uk. Her Majesty's Government of the United Kingdom. Retrieved 7 November 2016.
  2. ↑Kayne, Steven B; Jepson, Michael H, eds. (2004). Veterinary Pharmacy. Pharmaceutical Press.
  3. ↑"The Prescription Only Medicines (Human Use) Order 1997". www.Legislation.gov.uk. Her Majesty's Government of the United Kingdom. Retrieved 7 November 2016.
  4. ↑http://www.rpharms.com/mep/legal-classification-of-medicines.asp(subscription required)
  5. ↑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.
  6. ↑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.
  7. ↑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.
  8. ↑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.
  9. ↑"Medicines Act 1968", legislation.gov.uk, The National Archives, 1968 c. 67
  10. ↑"Medicines Act 1968", legislation.gov.uk, The National Archives, 1968 c. 67

Further reading

  • The Textbook of Pharmaceutical Medicine, John P. Griffin.