By law, the marketing authorisation holder is required to report the placement on the market, suspension or termination and subsequent renewal of marketing of a medicinal product in the Czech Republic.
Section 33, paragraph 2 of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended, stipulates the marketing authorisation holder's obligation to report the following to the State Institute for Drug Control (hereinafter referred to as “SÚKL”):
- The date of actual placement of a medicinal product onto the market in the Czech Republic by pack size and type of packaging, no later than within 2 months of the actual placement of the product onto the market;
- The date of suspension or termination of marketing of a medicinal product in the Czech Republic, no later than 2 months in advance thereof; where exceptional circumstances arise, it is possible to make such notification no later than upon the suspension or termination of marketing of the medicinal product in the Czech Republic, including the reasons for such suspension or termination;
- The date of resumed marketing of a medicinal product, without any delay.
SÚKL has prepared an electronic form for the purposes of this reporting.
Concurrently, SÚKL hereby notifies marketing authorisation holders of the necessity to report any available information clarifying the reasons for suspended or terminated marketing of a medicinal product (the provision of bare information such as “suspension” or “termination” is not sufficient). Furthermore, it is necessary to always provide additional information on the duration of the outage of the medicinal product or the date when supplies are planned to be resumed, together with the report on the suspension or termination of supplies. Such information is essential for safeguarding the respective therapy in clinical practice by means of alternative medicinal products, as applicable.
SÚKL would much appreciate if marketing authorisation holders reporting suspension or termination of supplies informed also on the existing stock levels and a plan to reduce risks in case of life-saving medicinal product outages (e.g. how it will be possible to obtain the product following revocation of marketing authorisation or in case of suspended marketing of the product).
The information provided shall serve solely for SÚKL's internal purposes, or, where applicable, for the internal purposes of the Ministry of Health of the Czech Republic.
Marketing Authorisation Branch
29 September 2015