State Institute for Drug Control

• medicinal products for which no consumption has been reported or  
• medicinal products which do not comply with the requirements stipulated by the Decree, i.e. in the period less than 10,000 DDDs have been placed on the market.  

The sunset clause, as referred to in Section 34, paragraph 3 of Act No 378/2007 Coll., on Pharmaceuticals, as amended, could be applied to these products.

For each medicinal product, the list provides the MA number, SÚKL code, product name, name supplement, and MRP number.  

The list is only for reference purposes and it is not binding. Should the information provided in the list not reflect reality, marketing authorisation holders are kindly requested to inform the below specified staff of the marketing Authorisation Branch as soon as possible and to support their information with relevant evidence.

Medicinal product jeopardised by the SC to 31.9.2012 version 1.xls, soubor typu xls, (387 kB)

Thus, if there are indeed reasons which satisfy the conditions laid down by the Act on Pharmaceuticals, these reasons have to be specified and, naturally, justified in the application. The Act on Pharmaceuticals does not stipulate any special form of application. An application lodged in compliance with Section 34, paragraph 3 of the Act on Pharmaceuticals must therefore meet the requirements of the Administrative Code. These are provided in Section 45, in compliance with Section 37, paragraph 2 of the Administrative Code.