The Human Medicines Regulations 2012 – and previously the Medicines Act 1968 – requires that medicinal products are licensed before they are marketed in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which directly approves medicines and issues the Marketing Authorisation (MA) to the manufacturer. The MA defines the therapeutic or diagnostic purposes (the clinical indications) for which a medicine may be marketed and provides the authority granted under the Medicines Act for the manufacturer to promote or sell the medicine for the approved clinical indication. The permitted clinical indications – also outlined in the product’s Summary of Product Characteristics (SPC) – are based on the data submitted by the MA holder during the licence application process. The MA also provides a regulatory safeguard for both healthcare professionals and patients when the medicine is prescribed.
Further protection is afforded by UK law via the Consumer Protection Act 1987 which ensures that the manufacturer of a medicine is strictly liable for any harm to a patient caused by a defective product.
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- Off-label or unlicensed use of medicines: prescribers’ responsibilities. MHRA.
- Good practice in prescribing and managing medicines and devices. GMC
- Standards of conduct, ethics and performance. General Pharmaceutical Council.
- The supply of unlicensed medicinal products (“specials”). MHRA Guidance Note 14. MHRA.
- The use of unlicensed medicines in pharmacy. RPSGB.
- Evidence summaries: unlicensed or off-label medicines. NICE.