27. Which marketing authorisation holder does apply for an exemption if there was a transfer of marketing authorisation holder – the old or the new one?
The application for exemption from the sunset clause after a lawful transfer of marketing authorisation shall be filed by the new (current) holder who assumes all rights and obligations of the original holder (Section 36 (4) of the Act on Pharmaceuticals) upon transfer of marketing authorisation. If transfer is not completed at the time of application submission, the application for exemption shall be submitted by the current marketing authorisation holder.
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