General information

In accordance with the new regulatory procedure (Order of MOH of Ukraine # 391, October 30, 2002) starting from 01.01.2006 all medicinal products that are being imported to the custom territory of Ukraine have to pass the every batch control (quality assurance). That means that samples from every batch number imported to Ukraine have to be controlled by local state laboratory.  
Up to the end of 2005 there were no such regulations regarding custom control, and quality assurance was performed randomize. New legislation will seriously raise the expenses: quality assurance per every batch cost approximately 2000 USD and takes 3-4 months.

The only way to prevent such expenses is a GMP-confession procedure of the manufacturing sites, performed by State Department for the Control over the Quality, Safety and Production of Therapeutic Agents and Medical Purpose Goods.

GMP-confession procedure is free from State fee for manufacturers from PIC/S countries (http://www.picscheme.org/), other companies would be charged to the sum equivalent to expenses for visit of state auditor of the manufacturing site (tickets, hotel etc.).
That mean that confession of GMP for PIC/S manufacturers – is only the paper work, all other countries follow the standard procedure of the GMP-confession that includes visit of state inspector of the manufacturing site(s).  

Service of Bureau "Cratia" includes:
► detailed description of the process;
► providing our Customer with the list of required documents in English or Ukrainian;
► explanations about requirements;
► translate of received documents to Ukrainian;
► submission of the dossier to the state authorities;
► defending interests of Customer;
► receipt of the GMP-confession certificate;

Approximate time to receive certificate is 1 months from the moment of submission of dossier, approximate time to prepare the dossier is 1,5 month from the moment of receipt.  

Certificate of the GMP-confession is valid for 2 years if procedure was performed first time and 5 years – after renewal of confession.