TABLE 1.
Legislation and regulation of medicines in the United Kingdom
| Legislation/regulation | Date | Purpose relevant to medicines |
|---|---|---|
| Pharmacy Wares, Drugs and Stuffs Act | 1540 (England) | To give physicians power over apothecaries |
| An Act “to prevent frauds and abuses in the making and vending of unfound, adulterated and bad drugs and medicines” | 1735 (Ireland) | To protect the public |
| Stamp Act | 1783 (England) | To raise money by taxing medicines |
| Apothecaries' Hall Act | 1791 (Ireland) | To regulate apothecaries and ensure the quality of medicines |
| Stamp Acts | 1802, 1804, 1812, 1815 | To raise money by taxing medicines |
| Apothecaries Act | 1815 (England) | To control the activities of apothecaries in preparing and dispensing medicines under the direction of “legally authorized physicians” |
| Sale of Arsenic Regulation Act | 1851 | To reduce the risks of criminal arsenic poisoning |
| Medical Acts | 1858, 1862 | To establish the licensing of doctors with the right to prescribe; to set up the British Pharmacopoeia |
| Offences Against the Person Act | 1861 | To criminalize the malicious administration of poisons |
| Poisons and Pharmacy Act | 1868 | To ensure the examination and registration of pharmacists; to identify scheduled poisons |
| Sale of Food and Drugs Acts | 1875, 1879 | To make the adulteration of food and drugs a crime |
| A Bill to Restrict the Sale of Patent Medicines | 1884 | To legislate against the sale of patent medicines (not enacted) |
| Indecent Advertisements Act | 1889 | To prevent misleading advertisements about ineffective treatments |
| Poisons and Pharmacy Act | 1908 | To regulate the sale of certain poisonous substances |
| Venereal Disease Act | 1917 | To prohibit treatment for venereal diseases except by registered medical practitioners |
| Dangerous Drugs Acts | 1920, 1923, 1925 | To limit the supply of drugs such as morphine, heroin, cocaine and amphetamines |
| Proprietary Medicines Bill | 1930‐31 | To regulate the manufacture, sale and advertisement of patent medicines |
| Pharmacy and Poisons Act | 1933 | To transfer the responsibility of regulating poisons from the Pharmaceutical Society to the Home Secretary, assisted by a Poisons Board |
| Medicines and Surgical Appliances (Advertisement) Bill | 1936 | To control patent medicines (not enacted) |
| Food and Drugs Act | 1938 | To prohibit the sale of any drug not of the nature, substance or quality demanded |
| Cancer Act | 1939 | To prohibit advertisements containing offers to treat, prescribe for or offer advice on cancer |
| Pharmacy and Medicines Act | 1941 | To regulate the patent medicine trade |
| Control of Penicillin Order No. 731 and Penicillin Act | 1946 and 1947 | To restrict the use of penicillin to qualified prescribers |
| Drugs Advisory Board Bill | 1963 | To set up the Committee on Safety of Drugs |
| Medicines Act | 1968 | To regulate the licensing, manufacture and advertising of medicines and to establish the Medicines Commission |
| Misuse of Drugs Act and Misuse of Drugs Regulations | 1971 and 1985 | To replace the 1968 Medicines Act and about 200 other pieces of secondary legislation; to encompass such matters as licensing, pharmacovigilance, sale and supply, and advertising |
| Poisons Act | 1972 | To supersede the Pharmacy and Poisons Act 1933, including licensing the sale of poisons |
| Medicinal Products: Prescription by Nurses etc. Act | 1992 | To extend prescribing rights to “registered nurses, midwives and health visitors” |
| Misuse of Drugs Regulations | 2001 | To supplement the 1985 regulations, allowing lawful possession and supply of controlled drugs for legitimate purposes |
| EU Directive (EC) No. 726/2004 | 2004 | To lay down community procedures for the authorization and supervision of medicinal products for human and veterinary use, and to establish the European Medicines Agency |
| EU Directive (EC) No. 1394/2007 | 2007 | To create a legal framework for advanced therapy medicinal products (gene therapy medicinal products, somatic cell therapy medicinal products and tissue‐engineered products) |
| EU Directive (EC) No. 536/2014 | 2014 | To require the reporting of results of clinical trials, including pharmacological interventions |
| Medicines And Medical Devices Act | 2021 | To require the Secretary of State to appoint a Patient Safety Commissioner |
| MHRA regulations | Various | See text |