The obligation of the marketing authorisation holder to establish and operate a Public Scientific Service (hereinafter referred to as the “VPOIS”) concerned with medicinal products has been implemented in accordance with § 33, Paragraph 3g), Section 1 of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals). This Act constitutes that the marketing authorisation holder must establish and operate a Public Scientific Service concerned with medicinal products that it has already registered and must inform the State Institute for Drug Control concerning the address and/or any change of address of the service. The Public Scientific Service may not be used for advertising and any information that it provides must be consistent with the Summary of product characteristics (SPC). Also included in the information provided through the Public Scientific Service is up-to-date information about whether or not the medicinal product is currently marketed in the Czech Republic. It therefore follows that this obligation is applicable to all the products registered by the marketing authorisation holder, regardless of whether or not they are currently available on the Czech market.
The marketing authorisation holder should fulfil this obligation via the designated e-mail address: vpois@suklcz.
We recommend including in the notification the following information:
- the details of the marketing authorisation holder – i.e. the name, address, the name of the responsible party and the e-mail address and the relevant phone number
- the manner of operation – a contact phone number, the e-mail address, the website
- to report a change indicate the current status of the operation and the new status subsequent to the change
3. 10. 2014
The Department for the Surveillance of Advertising