Section 6.2: More precise requirements regarding the application documentation: separate proof of 10-year authorisation of active substance and authorisation of reference medicinal product in EU/EFTA.
09.08.2019
Inclusion of Pipeline Review
Tab "New authorisation", line 1.12.1: More precise requirements regarding the application documentation: separate proof of 10-year authorisation of active substance and authorisation of reference medicinal product in EU/EFTA.
Tab "Application+Meeting": Adition column M "Pipeline Review"
The new versions of the affected documents enter into force as of 08.08.2019.