Well established use of a medicinal product means that the active substance has already been in medical use in the EU/EEA for at least 10 years (in the form of medicinal products without marketing authorisation), and that its efficacy is recognised and its level of safety is acceptable
If the applicant can prove the above, the requirement to submit results of preclinical or clinical studies may be waived under certain conditions. In this case, studies will be replaced by the appropriate scientific literature.