How can marketing authorisation be obtained for generic medicines?
A marketing authorisation is required for all generic medicines. In order to secure a marketing authorisation, the applicant must provide detailed information on the manufacturing methods and the quality of the ingredients used as well as the product itself, in accordance with EU legislation. This is in keeping with the requirements on the manufacturer of the original reference medicine. In addition, the applicant must demonstrate that the generic medicine is absorbed as effectively as the reference product (this requirement applies to orally administered solid medicines, such as tablets, only). This information is used to ensure that the generic medicine offers the same efficacy, safety and quality as the reference medicine.