Paragraph 10 Powers of licensing authority in connection with provision of informationF1

If the licensing authority requests a holder of a converted EU marketing authorisation to submit all or part of the baseline data at any time before the expiry of the period of one year beginning with IP completion day, the holder must supply the information within the time period specified by the licensing authority in its request.

If the licensing authority requests a holder of a converted EU marketing authorisation to provide any other information relating to the EU marketing authorisation, the holder must supply the information within the time period specified by the licensing authority in its request.