The pharmaceutical company Farmak (Kyiv) stands for mutual recognition of the results of good manufacturing practice (GMP) checks in production of medicines within the framework of the Ukraine-EU industrial dialogue. “A key prerequisite for realizing cooperation opportunities between the Ukrainian and European pharmaceutical sectors is to update the scope of the future ACAA agreement (Agreement on Conformity Assessment and Acceptance of Industrial Goods) with the EU. First of all, to include provisions on the mutual recognition of the results of audits of good manufacturing practice in the pharmaceutical sector (GMP),” Yevhenia Piddubna, the director for corporate communications at Farmak, told Interfax-Ukraine.
She also noted the high potential for the participation of the Ukrainian pharmaceutical industry in the diversification of European supply chains for critical medicines in the face of the COVID-19 pandemic.
Farmak is one of the oldest pharmaceutical companies in Ukraine, specializing in the production of modern high-tech drugs. At the company’s production sites, a pharmaceutical quality system has been introduced and it is constantly being improved in accordance with the current regulatory requirements and in accordance with international standards: ISO, GMP (Good Manufacturing Practice). The company undergoes several international inspections and audits annually.
The company is included in the top 100 largest taxpayers in Ukraine. In 2020, Farmak paid taxes totaling more than UAH 712 million, including UAH 120 million to the Kyiv city budget.
Farmak is a member of the Manufacturers of Medications of Ukraine association.
JSC Farmak pharmaceutical company (Kyiv) at the end of June 2019 received two new GMP (good manufacturing practice) certificates for two production sites and a new storage area commissioned at the beginning of the current year from the Polish regulatory authority, the press service of the company has said. According to the report, these sites have undergone planned recertification and confirmed their compliance with the EU’s GMP requirements.
The company passed state recertification conducted by the regulatory authorities of Ukraine and Poland in March of the current year. In particular, the company passed a GMP recertification by the State Service of Ukraine on Medicines and Drugs Control and a planned recertification of production sites, where products for the Polish market are manufactured, on the part of the Chief Pharmaceutical Inspectorate of Poland. According to the results of inspections, 19 production sites received national GMP certificates, and two more production and storage areas received European GMP certificates.
“This once again proves that the conditions in which Farmak products are manufactured comply with the European requirements. Today, all finished drug manufacturing facilities have national GMP certificates, 14 of them are certified by European regulatory authorities in Croatia and Poland. No one pharmaceutical company in Ukraine has such a level of European recognition,” Olha Oleksiychuk, the director for quality at Farmak, said.
