Drug database
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.
| GUIDELINE | NAME | ENG.VERSION | VALID SINCE | REPLACES | MAIN CHANGES | AMENDS |
|---|---|---|---|---|---|---|
| REG-97 | Requirements for submission of good quality national translations of product information and terminology used | NO | 1. 1. 2023 | – | ||
| REG-97 Annex 1 | Glossary of terminology | NO | 1. 1. 2023 | – | ||
| REG-96 version 2 | Requirements for the Submission of Mock-ups | YES | 1. 7. 2025 | REG-96 version 1 | The obligation to submit an amendment to the registration when reducing the number of languages on the packaging is removed, and the process is clarified in line with current practice. | |
| REG-95 version 1 | Application for renewal of parallel import authorisation | YES | 22. 3. 2021 | REG-95 | ||
| REG-94 version 3 | Application for Scientific Advice (Consultation) provided by Marketing Authorisation Section of SÚKL | YES | 3. 3. 2025 | REG-94 version 2 | Modifications in connection with the change of the domain and the SÚKL website; Information on follow-up and requested consultation; Adding a field to the (proposed) method of dispensing | |
| 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 | 1. 7. 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 | 1. 7. 2024 | REG-84 version 7 | ||
| REG-80 version 2 | Inclusion of a medicinal product previously authorized in the Czech Republic via national procedure into the Mutual Recognition Procedure or, where applicable, into the Decentralised Procedure | YES | 14. 4. 2025 | REG-80 version 1 | Revision to the current setup, including revision of Annex 1, which should be submitted by the applicant | |
| 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 version 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 2 | Requirements for marketing authorisations of medicinal products in respect of risk of transmitting animal spongiform encephalopathy agents | YES | 2. 1. 2026 | REG-59 version 1 | Update of the guideline relating to the submission of technical requirements for the security of medicinal products, deletion of invalid references, addition of a link to the EMA website, and deletion of Annex 1. | |
| 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. 7. 2025 | REG-29 version 4 | A comprehensive revision of the guideline related to the modification of the Institute’s assessment practices, based on suggestions from marketing authorization holders. |