Before a medicinal product* can be marketed in the UK, a marketing authorisation (formerly called a ‘product licence’) is needed. Such an authorisation can be granted in the European Union (EU), via the European Medicines Agency (EMEA), European Commission (EC) and member state's competent authorities or, specifically in the UK, via the Medicines and Healthcare product Regulatory Agency (MHRA) on behalf of the UK licensing authority.2–4 Also, a change to the authorisation is needed if the licensing status of a medicine is changed; for example, from a prescription-only medicine (POM) to a pharmacy medicine (P). Here we look at the procedures involved in the licensing of medicines (including herbal and homoeopathic products) for use in the UK.
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* A medicinal product is defined as any substance or combination of substances either with “properties for treating or preventing disease in human beings”, or that “may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis”.1