Medicinal Products - Manufacture - Guidelines
| Name | En. v. | 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 1 | Licence for Safeguarding the Quality and Safety of Human Tissues and Cells Intended for Use in Man | No | 01.06.2010 | ||
| VYR-36 | Clean Rooms | No | 01.03.2009 | ||
| VYR-35 version 1 | Procedure for licensing of manufacture of medicinal products and investigational medicinal products for the purpose of their import from third countries | No | 01.09.2008 | VYR-35 | |
| VYR-34 | Heat sterilisation processes | No | 01.08.2005 | VYR-12 | |
| VYR-33 | Ethylene oxide sterilization, sterilization by irradiation and estimation of the population of micro-organisms | No | 01.01.2005 | VYR-12 | |
| 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 2 | Application for an authorisation/change to authorisation for manufacture of blood components and materials derived from blood and its components for further manufacture | No | 22.01.2010 | VYR-29 version 1 | |
| 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-17 | Shelf life extension of a batch of medicinal product manufactured before the approval of the appropriate variation to the registration | Yes | 01.07.2001 | VYR-13 | |
| VYR-10 version 1 | General Requirements of SUKL on Validation of Aseptic Procedures | No | 01.03.2009 | VYR-3 and (1) |
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