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.
| Name | En. v. | Valid. since | Replaces | Amends | |
| REG-88 | Application for variation of parallel import authorisation | YES | 1.11.2011 | - | - |
| REG-87 |
Application for parallel import authorisation |
YES | 1.11.2011 | - | - |
| REG-86 |
Parallel import authorisation |
NO | 1.11.2011 | - | - |
| REG-85 version 1 | Slot allocation for decentralised marketing authorization procedure with Czech Republic as the RMS | YES | 5.10.2010 | REG-85 | - |
| REG-84 version 1 | Electronically submitted applications regarding marketing authorisation | YES | 1.10.2008 | REG-84 | - |
| REG-83 | Requirements on stability studies in registration dossier | NO | 1.9.2005 | REG-49 | - |
|
REG-81 version 1 |
Authorisation of medicinal gases | NO | 12.2.2009 | REG-81 | - |
|
REG-80 version 1 |
Inclusion of a medicinal product already authorised in the CR into Mutual Recognition Procedure | YES | 10.11.2008 | - | - |
|
REG-79 version 1 |
Active Substance Master File | YES | 3.6.2011 | REG-79 | - |
| REG-78 version 3 | Application form for CZ Outgoing Mutual Recognition Procedure | YES | 1.11.2011 | REG-78 version 2 | - |
| REG-77 version 3 | Application for variation to a marketing authorisation | YES | 1.1.2010 | REG-77 verze 2 | |
| REG-76 version 1 |
Variations to marketing authorisations of products authorised via the national procedure |
YES | 1.1.2010 | REG-76 | |
| REG-75 version 1 | Categorisation of medicinal products as selected pharmaceuticals | NO | 21.10.2008 | REG-56 | - |
| REG-73 version 1 | Application for renewal of marketing authorisation | YES | 17.9.2009 | REG-73 | |
| Application for revocation of the registration of medicinal product | YES | 18.5.2011 | REG-72 | ||
| Application for transfer of marketing authorisation | YES | 29.6.2011 | REG-69 | ||
| REG-62 | Parametric release | NO | 1.3.2002 | - | - |
| REG-60 version 1 | Requirements for the Registration of medicinal products manufactured using material derived from human blood or blood components | 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-57 | Requirements on the information on the packaging material of medicinal products | NO | 1.7.2001 | REG-10, REG-30 | - |
| REG-52 | Colouring matters permitted for use in medicinal products - amendment | NO | 1.8.2000 | - | REG-40 |
| Maximum shelf-life for sterile products after first opening or after reconstitution | YES | 1.1.2000 | - | - | |
| REG-41 | Classification of medicinal products - guidance for applicants for classification of medicinal product as non-prescriptional one | NO | 1.1.1999 | - | - |
| REG-40 | Colouring matters permitted for use in medicinal products | NO | 1.1.2000 | - | - |
| Names of medicinal products | YES | 1.9.2010 | REG-29 version 1 | - |
cz