Information for marketing authorisation holder

Notification of Request for Exemption to Continue Medicinal Product Batch Control Testing in the United Kingdom (UK) after Brexit

SÚKL hereby informs marketing authorisation holders on cases of notification of request for a time-limited exemption to continue medicinal product batch control testing in the UK for medicinal products authorised via the MRP/DCP.  

 

Waiver of Reimbursement of Costs for Additional Strengths/Pharmaceutical Forms of a Particular Product upon Take-over of the Role of the RMS Due to Brexit

Upon request, SÚKL shall waive the payment of reimbursement of costs for additional strengths/pharmaceutical forms of a medicinal product in respect of which it will take over the role of the RMS from Great Britain in the period from 1 December 2018 to 29 March 2019.  

 

Reminder of the method of provision of information upon suspension or termination of marketing of medicinal products

SÚKL hereby reminds marketing authorisation holders of the necessity to provide available information when reporting suspension or termination of marketing of a medicinal product in the Czech Republic.   

 

Centralised Procedure Documentation – change in submission to Czech NCA

The introduction of the Common Repository in February 2014 by European Medicines Agency has enabled Czech NCA to use the system as the only source of Centralised Procedure submissions, therefore there is no longer required to submit additional copies of submissions in form of CDs/DVDs by mail. This applies to all types of Centralised Procedure related to centrally authorised products submitted in eCTD format apart of listed exceptions.    

 

Changes in Sending Decisions/Notifications/Notices to Physical Entities and Foreign Legal Entities without a Data Box

The State Institute for Drug Control (hereinafter referred to only as the “Institute”) informs marketing authorisation holders about the new method of sending the decisions/notifications/notices concerning applications for marketing authorisation, renewal, variation, transfer of marketing authorisation as well as applications for parallel import authorisation, etc. to physical entities and foreign legal entities without a data box, with effect from November 6, 2013.    

 

Information on the duty to use certified electronic signature in communication with the State Institute for Drug Control

The State Institute for Drug Control (“Institute”) informs marketing authorisation holder on options of submission of amendment and of their duty to use email with the certified electronic signature in their official communications with the Institute (e.g. when submitting additional dossier in administrative proceedings, national translations of the SmPC, PIL and labelling).  

 

Obligations Applicable to Holders of Centralised Marketing Authorisations

Obligations applicable to Marketing Authorisation Holders of Products Authorised via the Centralised Procedure in relation to State Institute for Drug Control.    

 

Change concerning the submitting of applications for renewal of marketing authorisation

The State Institute for Drug Control (SÚKL) hereby informs of a change concerning the submitting of applications for renewal of marketing authorisation introduced by the amended Act on Pharmaceuticals.  

 

Termination of MRP type I and II variations without a decision on marketing authorisation variation

Information for marketing authorisation holders  

 

Finalisation of MRP variations type I without notification

Information for marketing authorisation holder.   

 

Information on the EU Synchronisation of PSUR submission

SÚKL Information for Marketing Authorisation Holders on the EU Synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures.