Under Act No. 378/2007 Coll., on Pharmaceuticals, marketing authorisation holders are required to inform the Institute without delay of changes in information required for the coordination between the Institute and the marketing authorisation holder.
This applies to changes in the contact details of:
- Marketing authorisation holders (Section 33(3)(e) of the Act on Pharmaceuticals)
- Representative authorised to liaise with the Institute (Section 33 of Act No. 500/2004 Coll., Rules of Administrative Procedure)
- Qualified representative responsible for pharmacovigilance (Section 91(3) of the Act on Pharmaceuticals)
- Contact addresses of publicly accessible specialist information service of the medicinal products of the marketing authorisation holder (Section 33(3)(g)(1) of the Act on Pharmaceuticals).
How to report changes in contact details
We ask all your marketing authorisation holders to report any changes in any of the contact details required for uninterrupted communication with the Institute electronically at posta@suklcz or in writing at:
Státní ústav pro kontrolu léčiv
100 41 Praha 10