Authorising of medicinal products
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 forms for marketing authorisation of medicinal products for human use, their renewal or variation are currently being revised. Until 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.
| GUIDELINE | NAME | ENG.VERSION | VALID SINCE | REPLACES | MAIN CHANGES | 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 2 | Application for Scientific Advice (Consultation) provided by Marketing Authorisation Section of SÚKL | YES | 24.5.2022 | REG-94 version 1 | dividing up the originally bilingual version into CZ and EN version; omitting the file mark in the administrative data field; adding information about GDPR | |
| 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 3 | Guideline for notified bodies applying for a scientific opinion (consultation) on ancillary medicinal substance that is an integral part of medical device | YES | 1.2.2024 | REG-91 version 2 | ||
| 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 6 | Documents Attached to Marketing Authorisation Renewal Applications for medicinal products authorised via national procedure | YES | 01.07.2024 | REG-89 version 5 | ||
| REG-88 version 1 | Application for variation of parallel import authorisation | YES | 22.3.2021 | REG-88 | ||
| REG-87 version 4 | Application for parallel import authorisation | YES | 31.10.2022 | REG-87 version 3 | In point 2 of the application, based on Section 45, paragraph 1 of the Medicines Act, a statement was added that the applicant is not in any relationship with the holder of the decision on the registration of the reference preparation. | |
| REG-86 version 3 | Authorization of parallel import of a medicinal product | NO | 24.10.2017 | REG-86 version 2 | ||
| REG-84 version 8 | Electronically submitted applications regarding marketing authorisation | YES | 01.07.2024 | REG-84 version 7 | ||
| 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-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 | ||
| Guideline on Assessment of Acceptability of Medicinal Product Names for the Purposes of Marketing Authorisation Procedure | YES | 1.1.2017 | REG-29 version 3 |