Application for approval to import a medicinal product from a third country

Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (hereinafter  referred to as „the Act on Pharmaceuticals“), in section 77, paragraph 1 letter i) establishes the distributor’s obligation in the case of importing a medicinal product from a third country that is not authorised in any of the Member States or in the European Union, in compliance with section 8 paragraph 3 to 5, must import medicinal product only after obtaining approval from the State Institute of Drug Control based on a request; however, this does not apply if the import of such a medicinal product is approved within a specific therapeutic program or is carried out according to section 8 paragraph 6.

The application must contain information about the applicant, the medicinal product, its manufacturer, and the relevant healthcare provider. The scope of this data is specified in section 46 of Decree No. 229/2008 Coll., on the Manufacture and Distribution of Pharmaceuticals.

application form

Authorize the data entered into the form using a recognized electronic signature. Please note that the electronic form is signed using the eRecept Signer application (instructions for installing the eRecept Signer component can be found here). Authorized data is securely transmitted to the State Institute for Drug Control (SÚKL) database without the need for further user intervention. The acceptance of the application is automatically confirmed for the needs of the distributor.

The State Institute of Drug Control will not approve the consent if the available information on the safety, efficacy, and quality of the medicinal product does not sufficiently demonstrate a favorable benefit-risk ratio associated with the medicinal product.

The State Institute for Drug Control warns that failure to comply with the aforementioned obligation may lead a distributor, according to section 105 paragraph 2 letter j) of the Act on Pharmaceuticals, to commit an offense for which a fine of up to 5,000,000 CZK can be imposed under section 107 paragraph 1 letter c).

22. 3. 2024

Medicine Shortage and Availability Unit