The transition period from the effective day of the amended Act on Pharmaceuticals until Jul. 21, 2015 also applies in the CZ and during this time a marketing authorisation holder is required to introduce the Pharmacovigilance System Master File and include the pharmacovigilance system summary in the registration dossier. This procedure can be carried out in the following way:
at the time of submission of an initial marketing authorisation application
at the time of submission of the renewal application
by submitting marketing authorisation variation (from Aug. 4, 2013 Variation Regulation No. 712/2012 applies also for national marketing authorisations)
In relation to marketing authorisation applications in progress – by supplementing the application
Marketing authorisation holders must introduce the pharmacovigilance system summary no later than Jul. 21, 2015 also in relation to those medicinal products whose registration dossier has not so far included the DDPS.
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).