GMP-recognition procedure.

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

Bureau Cratia Ltd. can provide consulting service of the GMP-recognition for all our customers and any other foreign manufacturers of the medicinal products.
Intermediate service 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-recognition certificate;

Manufacturers from PIC/S* countries follows the simple procedure of GMP-recognition. In that case approximate time to receive certificate is 20 days from the moment of submission of dossier.

All other countries follow the standard procedure of the GMP-recognition that includes visit of state inspector of the manufacturing site(s).

*List of PIC/S countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Malaysia, Netherlands, Norway, Portugal, Romania, Singapore, Slovak Republic, Spain, Sweden, Switzerland, United Kingdom (source: http://www.picscheme.org/).