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Application Form for Approval of Placing a Foreign-Language Batch of Medicinal Product on the Market

An electronic form is used to submit an application to enable the introduction of individual batches of a medicinal products on the market when the packaging information is in a language other than Czech.  

For application submission, please complete the following electronic form:

An application for approval of placing on the market of medicinal product batches with labelling in other than the Czech language

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, and the procedure in case of technical problems 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 applicant.

22. 3. 2024

Medicine Shortage and Availability Unit

Notice to applicants for placing of foreign language batch of a medicinal product on the market, 30.10.2018

Notice to applicants on requirements to permit the placing of foreign language batch of a medicinal product on the market in the Czech Republic.