Jul 24, 2019

Two GMP certificates were issued to Farmak by Polish regulatory authority

At the end of June, the European database EudraGMDP has been replenished with new GMP certificates that were issued by the regulatory authority of Poland to JSC “Farmak” for 2 manufacturing sites and a new storage site put into operation in the beginning of 2019. The planned recertification of 2 manufacturing sites confirmed their compliance with GMP EU requirements. The storage site was inspected by European authority for the first time.

The inspections logically resulted in obtaining the certificates. In March, the regulatory authorities of Ukraine and Poland conducted two extensive state certifications at Farmak. During the continuous inspections lasting for almost 2 weeks, the Company was subject to the planned recertification for compliance with GMP conducted by the State Service of Ukraine on Medicines and Drug Control, and the planned recertification of the manufacturing sites, where the products intended for market of Poland are manufactured, conducted by the Chief Pharmaceutical Inspectorate of Poland.

Due to coordinated and hard work of Farmak team, following the inspections, the national GMP certificates were issued to 19 manufacturing sites, and the European GMP certificates were issued to 2 manufacturing sites and a storage site.

 

“We repeatedly claimed that Farmak built Europe here, in Ukraine. And these are not mere words. The level of compliance with the European Union regulations, and the opportunity to sell the products of JSC Farmak, in particular, in the market of Poland and other European countries, are confirmed by re-obtaining of GMP certificate. This is another confirmation that the manufacturing conditions of Farmak’s products comply with the European requirements. Today, all sites where finished medicinal products are manufactured have national GMP certificate, 14 of them are certified by the European regulatory authorities of Croatia and Poland. No other pharmaceutical company in Ukraine has such level of European recognition”, said Olga Oleksiichuk, Quality Director at JSC Farmak.

According to http://eudragmdp.ema.europa.eu, 3 of 10 valid European GMP certificates issued to 7 Ukrainian companies were issued to JSC “Farmak”. National GMP certificates were issued to 20 manufacturing sites of JSC “Farmak”. European GMP certificates cover 14 manufacturing sites and 1 storage site of JSC “Farmak”.

 

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