Reporting a change in contact details Dear users, Pursuant to the amended Act No 79/1997 Coll. on Pharmaceuticals (amended by Act No 129/2003 Coll.) marketing authorisation holders, manufacturers, distributors, blood centres, and control laboratories are obliged to forthwith notify to SÚKL any changes to details necessary for continuous communication with SÚKL. As for marketing authorisation holders, this obligation applies to details about the marketing authorisation holders proper, their authorised person(s), person responsible for Pharmacovigilance, and the Public Expert Information Service (VPOIS).
Procedure of notifying changes of contact details
All marketing authorisation holders, manufacturers, distributors, blood centres, and control laboratories are requested to notify SÚKL of any change to any of their contact details necessary for continuous communication with the Institute electronically to: posta@sukl
cz or in writing to the following address:
Šrobárova 48
100 41 Praha 10
Czech RepublicThose changes in contact details which require a variation to the relevant authorisation (such as a change to the name or address of the marketing authorisation holder or manufacturer, distributor, control laboratory or blood centre), still have to be made on the basis of the relevant application (Application for Type I variation to marketing authorisation, Application for variation to marketing or distribution authorisation).
