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Licensing

Medicines are among the most heavily regulated products in the world. In the UK, they are licensed either by the Medicines and Healthcare products Regulatory Agency (MHRA), which ensures that our medicines work and are safe, or the European Medicines Agency (EMA), which coordinates medicine licence applications within the European Union.

Companies must provide substantial evidence of safety and effectiveness when applying for a Marketing Authorisation Application, and often extra information and further tests will be asked for by the regulators. It can take up to two years to gain a licence. Pharmaceutical companies are required to meet the costs of medicine regulation.