What does ‘unlicensed’ mean?

Where there is an unmet clinical need, physicians can consider prescribing unlicensed medicines – meaning medicines that are still in development or are available in a country other than the patient’s own. Many countries have formal regulatory pathways to allow access to medicines in this scenario – it is not illegal, but it is a last resort.

Because of the complexity involved and the often time-critical nature of the patient need, it is essential to use a partner who has been there and done it before. We can help.

Explore our popular questions about unlicensed medicines

Learn more about regulatory pathways

Common questions about importing

  • How can you reduce the risk of counterfeit?


  • What is a regulatory pathway and why do they matter?