Appointment/change of the contact person for pharmacovigilance issues in the Czech Republic

Pursuant to Sec. 91a (3) of the Act on Pharmaceuticals, the State Institute for Drug Control hereby requests the marketing authorisation holders to appoint a contact person for pharmacovigilance issues in the Czech Republic and to notify about this the Pharmacovigilance Department of SÚKL.

This obligation applies to all marketing authorization holders, regardless of the location of the PSMF.

Requirements for the contact person for pharmacovigilance issues

The contact person for pharmacovigilance issues shall fulfil the following:

• be able to communicate in Czech or Slovak language,
• be contactable on a phone number with the Czech country code,
• reside in the EU.

The QPPV and the contact person for pharmacovigilance issues may be the same person. The contact person for pharmacovigilance issues is a part of the marketing authorization holder’s pharmacovigilance system, whose responsibilities are set out and listed in the PSMF. The minimum responsibility of the contact person for pharmacovigilance issues is to provide the contact between SÚKL and the QPPV.

How to report contact person for pharmacovigilance issues appointment/change 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 (contact person for pharmacovigilance issues appointment or change) and the name of the represented marketing authorization holder. In case of change involving several marketing authorization holders, all represented holders shall be indicated in the body of the e-mail, only one of them shall be indicated in the subject of the e-mail.

The contact information in the body of the e-mail must include name, e-mail address and telephone number of the contact person for pharmacovigilance issues and the name of the represented marketing authorization holder (all represented marketing authorization holders). The marketing authorization holder may also inform SÚKL of the contact person’s deputy if one is appointed. The procedure is the same as for the contact person for pharmacovigilance issues.

Deadline for reporting contact person for pharmacovigilance issues appointment/change to SÚKL

Marketing authorization holders shall notify the Pharmacovigilance Department of SÚKL within 7 calendar days following the appointment/change of the contact person for pharmacovigilance issues or change of their contact details.