Modification of various documents relating to authorisation


Further details regarding the issuing of document protection for the simultaneous authorisation of a medicinal product with a new active substance and of a corresponding extension (section 5.2).

Further details on the conditions to be fulfilled in order for document protection to be extended to 10 years for innovative indications (section 5.4).

The ICH M9 guideline on biopharmaceutics classification system-based biowaivers has been completed. Swissmedic has updated the guidance document Authorisation of human medicinal product with known active substance HMV4 accordingly.