State Institute for Drug Control

In view of the fact that SÚKL is responsible for surveillance of companies which have the  Pharmacovigilance System Master File (PSMF) located in the territory of the Czech Republic and it is only the PSMF summary instead of DDPS (format of the description of the pharmacovigilance system required previously) that shall be a part of the registration dossier, there is no other possibility of how to learn about changes in the pharmacovigilance system of these companies other than to include the obligation to inform SÚKL about the PSMF changes in the  Act on Pharmaceuticals. However, it concerns only major changes such as for example a change in the database, change in the contractual partner etc. Changes which are to be reported are specified in the PHV-6 Guideline (applicable from Jul. 1, 2013).