Notification Regarding the Establishment, Operation Method, and Address Change of the Public Scientific Service (“VPOIS”) for medicinal products

Pursuant to Section 33(3)(g)(1) of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), the marketing authorization holder is obliged to establish and operate a Public Scientific Service (hereinafter referred to as the “VPOIS”). This service must ensure access to accurate and up-to-date information regarding all medicinal products authorised for the holder in the Czech Republic. The VPOIS may not be used for advertising and any information provided through the service must be consistent with the Summary of Product Characteristics (SmPC). The information must also include current details on whether or not the medicinal product is being placed on the market.

Notifications concerning the establishment, method of operation, or changes to the address of the VPOIS must be submitted by the marketing authorization holder to the designated e-mail address: vpois@sukl.gov.cz.

It is recommended to include the following details in the notification:

• Details of the marketing authorization holder (full company name, registered office address, name of the responsible person, contact e-mail, and phone number).
• Method of service operation (e-mail, phone number, and website).
• For reporting changes to the VPOIS, both the current and updated operational details should be provided.