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