Guidelines and Forms

The below instructions and applications relate to procedures specific for the Czech Republic. In order to file applications for registration via DCP/MRP and national as well as applications for extension of validity of registration and for change of registration for medicines registered via DCP/MRP, please use the respective application forms published in EUDRALEX, Volume 2 - Pharmaceuticals Legislation: Notice to Applicants

Medicinal Products - Registration

Application form for marketing authorisation of medicinal products for human use, their renewal or variation are currently being revisedUntil publication of the new versions, please, use the corresponding forms from Eudralex, Volume 2 - Pharmaceuticals Legislation: Notice to Applicants -

  Name En. v. Valid. since Replaces Amends
REG-95 Application for renewal of parallel import authorisation YES 4.11.2014    
REG-94 Application for Scientific Advice (Consultation) provided by SÚKL, Marketing Authorisation branch YES 22.10.2014    
REG-93 Subsequent Application for a scientific opinion on ancillary medicinal substance that is an integral part of a medical device (variation) YES 1.1.2015    
REG-92 Application for a scientific opinion on ancillary medicinal substance that is an integral part of a medical device YES 1.1.2015    
REG-91 Guideline for notified bodies applying for consultation on ancillary medicinal substance in medical device YES 1.1.2015    
REG-90 Application for change to the labelling or package leaflet not connected with summary of product characteristics YES 04.08.2013    
REG-89 version 3 Documents Attached to Marketing Authorisation Renewal Applications YES 05.04.2016 REG-89 version 2  
REG-88 Application for variation of parallel import authorisation YES 01.11.2011    
REG-87 version 2

Application for parallel import authorisation

YES 4.11.2014    
version 2

Parallel import authorisation

NO 04.01.2016  REG-86
version 1 
REG-85 version 2 Slot allocation for decentralised marketing authorization procedure with Czech Republic as the RMS YES 27.10.2014 REG-85 version 1  
REG-84 version 4 Electronically submitted applications regarding marketing authorisation YES 1.7.2015 REG-84 version 3  
REG-83 Requirements on stability studies in registration dossier NO 01.09.2005 REG-49  
version 1
Authorisation of medicinal gases NO 12.02.2009 REG-81  
version 1
Inclusion of a medicinal product already authorised in the CR into Mutual Recognition Procedure YES 10.11.2008    
REG-78 version 5 Application form for CZ Outgoing Mutual Recognition Procedure YES 18.11.2013 REG-78 version 4  
REG-75 version 1 Categorisation of medicinal products as selected pharmaceuticals NO


REG-41 version 2


REG-72 version 2

Application for revocation of the registration of medicinal product YES 02.04.2013 REG-72 version 1  

REG-69 version 3

Application for transfer of marketing authorisation YES 05.08.2013 REG-69 version 2  
REG-60 version 1 Requirements for the Registration of medicinal products manufactured using material derived from human blood or blood components NO 23.01.2009 REG-60  
version 1
Requirements for marketing authorisations of medicinal products in respect of risk of transmitting animal spongiform encephalopathy agents YES 28.01.2009 REG-59  

REG-46    version 1

Maximum shelf-life for sterile products after first opening or after reconstitution YES 01.01.2000    
REG-41  version 2 Classification of medicinal products - guidance for applicants for classification of medicinal product as non-prescriptional one NO 19.12.2014 REG-41 version 1  

REG-29 version 3       

The methodology of assessing the acceptability of names of medicinal products for the purposes of the registration procedure NO 22.07.2016 REG-29       version 2