Manufacture of pharmaceuticals

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   

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 2 Issuing of GMP Certificates for Active Pharmaceutical Ingredients No 16.9.2015 VYR-31 version 1  
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 3 Application for an authorisation/change to authorisation for manufacture of medicinal products and guidance for provision of detailed information on manufacture No 15.01.2013 VYR-27 version 2  
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)