Manufacture of pharmaceuticals
Medicinal Products – Manufacture – Guidelines
| Guideline | Name | Eng.version | valid since | replaces | amends |
|---|---|---|---|---|---|
| VYR-41 verze 1 | Notification of Activities of Importers, Manufacturers and Distributors of APIs and Their Registration in EU Database | No | 06.10.2014 | VYR-41 | |
| VYR-40 | Information on a new format of manufacturing authorization and GMP certificate | No | 26.2.2013 | ||
| VYR-39 version 3 | Licence for Safeguarding the Quality and Safety of Human Tissues and Cells Intended for Use in Man | No | 10.08.2018 | VYR-39 version 2 | |
| VYR-32 version 3 | Guidelines for Good Manufacturing Practice | No | 01.12.2011 | VYR-32 version 2 | |
| VYR-31 version 3 | Issuing of GMP Certificates for Active Pharmaceutical Ingredients | No | 01.08.2018 | VYR-31 version 2 | |
| VYR-30 version 3 | Issuing of GMP Certificates for Medicinal Products | No | 12.10.2015 | VYR-30 version 2 | |
| VYR-29 version 4 | Application for an authorisation/change to authorisation for manufacture of blood components and materials derived from blood and its components for further manufacture | No | 10.08.2018 | VYR-29 version 3 | |
| VYR-27 version 5 | Application for an authorisation/change to authorisation for manufacture of medicinal products and guidance for provision of detailed information on manufacture | No | 01.08.2018 | VYR-27 version 4 | |
| VYR-26 version 2 | Guidelines for good manufacturing practice for active pharmaceutical ingredients | No | 31.07.2010 | VYR-26 | |
| VYR-10 version 1 | General Requirements of SUKL on Validation of Aseptic Procedures | No | 01.03.2009 | VYR-3 and (1) |