Is it necessary to send to SÚKL a notification of suspension in case of a variation to marketing authorisation which results in suspended marketing?

Yes, if the variation to marketing authorisation is of such nature which results in suspension of deliveries of the respective medicinal product for the purposes of distribution, the MA holder should, at least 2 months in advance of the suspension of the marketing, notify SÚKL to this effect, specifying the reason for suspension in compliance with Section 33, paragraph 2 of the Act on Pharmaceuticals. Where exceptional circumstances arise, such notification may be made no later than concurrently with the suspension of marketing of the concerned medicinal product in the Czech Republic.