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It is no news that in the Czech and Slovak Republic, a local person must be responsible for the registration of medicines on the basis of full power of attorney. In our practice, we often encounter problems in the case of power of attorney. The Czech Republic, in particular, has a very complicated law that […]

A Journal newsletter on the adverse effects of drugs – called Nežádouci účinky léčiv, will be published very soon on the website of Czech State Institute for Drug Control (SÚKL). This informative newsletter is about undesirable effects detected by SÚKL.MAH must NOT report the adverse effects found in this newsletter to Eudravigilance and SÚKL!Save your […]

Brief description of local requirements. 1. How long does it take to do RMP educational materials application to Local health authority?Application procedure – once you have translated educational material in graphic design you send educational material together with distribution plan to authority for evaluation. Authority has example of cover letter for educational materials and has example […]

Medical devices notification in Slovakia becames very popular but the procedure itself is not as easy as many clients think. In Slovakia we have of course national specifications which we needs to follow. The first important step is to have registered importer or registered distributor responsible for Medical Devices. What does it mean to have […]