The licensing of medicines in the UK

doi:10.1136/dtb.2009.03.0012

Drug and Therapeutics Bulletin 2009;47:45-47; doi:10.1136/dtb.2009.03.0012

The licensing of medicines in the UK

^{^*} A medicinal product is defined as any substance or combinationof substances either with "properties for treating or preventingdisease in human beings", or that "may be used in or administeredto human beings either with a view to restoring, correctingor modifying physiological functions by exerting a pharmacological,immunological or metabolic action, or to making a medical diagnosis".¹

Before a medicinal product* can be marketed in the UK, a marketingauthorisation (formerly called a ‘product licence’)is needed. Such an authorisation can be granted in the EuropeanUnion (EU), via the European Medicines Agency (EMEA), EuropeanCommission (EC) and member state's competent authorities or,specifically in the UK, via the Medicines and Healthcare productRegulatory Agency (MHRA) on behalf of the UK licensing authority.²^–⁴Also, a change to the authorisation is needed if the licensingstatus of a medicine is changed; for example, from a prescription-onlymedicine (POM) to a pharmacy medicine (P). Here we look at theprocedures involved in the licensing of medicines (includingherbal and homoeopathic products) for use in the UK.