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.    

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. It enables our Agency to search, browse and download all centralised procedure eCTD submissions for human products which are provided to the EMA via the eSubmission Gateway/Web Client. The Czech NCA is now ready to proceed with the system.

Consequently as these submissions are made available to our Agency via the Common Repository 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 except the submissions mentioned below.

 

There are still some exceptions where SUKL require to receive the hard copies in form of CD and these are:

  • documentation related to the work-sharing procedure (according to the Article 20 of Commission Regulation (EC) No 1234/2008 as amended by Commission Regulation (EU) No 712/2012) with EMA acting as a reference authority in which at least one of the marketing authorisations is a marketing authorisation approved by national or DCP/MRP procedure – in this case the dossier must be submitted through standard options for applications (data box, originally signed application form along with CD / DVD sent by mail or courier);
  • documentation related to any Referral procedures;

Recently we have improved our procedures and now we are able to download RMPs and ASMFs files from the Common Repository which was not possible formerly.

 

We kindly ask MAHs to consider the above mentioned advice and accommodate their internal procedure in such way that eliminate:

Státní ústav pro kontrolu léčiv

(CHMP members: Ondřej Slanař and Radka Montoniová)

Šrobárova 48
100 41 Praha 10

The Czech Republic

from the centralized procedures submissions (CD/DVD copies) provided by post. Such a step will significantly reduce the number of submissions sent by MAH thereby reducing time and costs related to submissions.

Important: Common Repository is NOT yet used in all EU NCAs at the moment. Applicants should continue sending submissions to all other NCAs as per the published Dossier Requirements for Centrally Authorised Products document until their own notice. Regular updates on NCAs joining the use of Common Repository is published on EMA‘s webpage:

http://esubmission.ema.europa.eu/central_repository.HTML

 

Marketing Authorisation Branch
10. 6. 2014

Updated 11. 8. 2014