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.
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