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 - http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm

  Name En. v. Valid. since Replaces Amends
REG-96 version 1 Requirements Governing the Submission of Graphic Designs of Medicinal Product Packaging (Mock-ups) NO 1.4.2019 REG-96  
REG-95 version 1 Application for renewal of parallel import authorisation YES 22.3.2021 REG-95  
REG-94 version 1 Application for Scientific Advice (Consultation) provided by SÚKL, Marketing Authorisation branch YES 14.9.2017 REG-94  
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 version 1 Guideline for notified bodies applying for consultation on ancillary medicinal substance in medical device YES 1.5.2017 REG-91  
REG-90 version 1 Application for change to the labelling or package leaflet not connected with summary of product characteristics YES 1.10.2020 REG-90  
REG-89 version 4 Documents Attached to Marketing Authorisation Renewal Applications for medicinal products authorised via national procedure YES 1.10.2020 REG-89 version 3  
REG-88 version 1

Application for variation of parallel import authorisation

YES 22.3.2021 REG-88  
REG-87 version 3 Application for parallel import authorisation YES 22.3.2021 REG-87 version 2  
REG-86 version 3

Authorization of parallel import of a medicinal product

NO 24.10.2017 REG-86 version 2  
REG-84 version 7

Electronically submitted applications regarding marketing authorisation

YES 1.6.2020 REG-84 version 6  
REG-83

Requirements for stability studies in the registration dossier

NO 1.9.2005 REG-49  
REG-80 version 1

Inclusion of a medicinal product previously authorized in the Czech Republic in the Mutual Recognition Procedure or, where applicable, in the Decentralised Procedure 

YES 10.11.2008 REG-80  
REG-78 version 6

Application form for CZ outgoing mutual recognition procedure

YES 7.12.2018 REG-78 version 5  
REG-72 version 3

Application for revocation of the marketing authorisation of medicinal product

YES 14.11.2018 REG-72 version 2  
REG-69 version 4

Application for transfer of marketing authorisation

YES 1.4.2019 REG-69 version 3  
REG-60 verze 1

Requirements for the marketing authorization of medicinal products in the manufacture of which substances derived from human blood or its constituents have been used

NO 23.1.2009 REG-60  
REG-59 version 1

Requirements for marketing authorisations of medicinal products in respect of risk of transmitting animal spongiform encephalopathy agents

YES 28.1.2009 REG-59  
REG-46 

Maximum shelf-life for sterile products after first opening or after reconstitution

YES 1.1.2000    
REG-41  version 3 Classification of medicinal products - guidance for applicants for classification of medicinal product as non-prescriptional one NO 1.8.2020 REG-41 version 2  

REG-29 version 4 

Guideline on Assessment of Acceptability of Medicinal Product Names for the Purposes of Marketing Authorisation Procedure YES 1.1.2017 REG-29       version 3