Changes to the Pharmacovigilance System Master File which need to be reported to SÚKL
Pursuant to Sec. 91(2)(b) of the Act on Pharmaceuticals, marketing authorization holders are obliged to inform SÚKL about a change in the Pharmacovigilance System Master File, if this master file document is located in the territory of the Czech Republic.
Changes in PSMF, which need to be reported to SÚKL:
- Change of the QPPV – Change of the contact details of the QPPV (e-mail address, telephone number, and postal address)
- Change of the PSMF location – Change of the name of the marketing authorisation holder
- New pharmacovigilance database (replacement of the entire system including data migration)
- Change in the pharmacovigilance database, which includes the migration of data from another entity into the pharmacovigilance database of the given marketing authorization holder (not information about regular updates or outward migration)
- New contractual / licensing partner who carries out some of the pharmacovigilance activities relevant for products authorised in the Czech Republic
- New patient program or register, etc.
- Information on a completed pharmacovigilance system audit (internal or external) which resulted in critical or major findings
How to report requested PSMF changes to SÚKL
Marketing authorization holders shall inform the Pharmacovigilance Department of SÚKL via e-mail to farmakovigilance@sukl.gov.cz. The subject of the e-mail shall include information on the type of change (PSMF change) and the name of the marketing authorization holder. For shared pharmacovigilance systems, only the first marketing authorization holder indicated on the front page of the PSMF shall be included in the subject of the e-mail, the other marketing authorization holders shall be listed in the body of the e-mail.
Deadline for reporting requested PSMF changes to SÚKL
Marketing authorization holders shall notify the Pharmacovigilance Department of SÚKL within 7 calendar days following the implementation of changes.