Drug database
Does the holder of marketing authorisation for medicinal product XY which had been placed on the market prior to the effective date of Act No 378/2007 Coll. (before 31 December 2007) have to notify SÚKL of suspended or terminated or renewed marketing of the medicinal product in the Czech Republic?
Yes, they do. The notification duties apply to all changes to the marketing of all medicinal products in the Czech Republic regardless of the date of the initial placement of the concerned medicinal product onto the market in the Czech Republic.