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.
The State Fiscal Service of Ukraine in January 2019 issued 9,707 EUR.1 movement certificates that allow goods of Ukrainian origin benefiting from favorable trade terms under a preferential trade policy of the EU, the authority has reported on its website.
The authority said that in general, during the 2016-2018 years, customs officers issued 219,000 certificates.
“As of February 1, 2019, the status of an authorized exporter has been granted to 231 enterprises, which export their products to EU countries on preferential terms,” the State Fiscal Service said.
The authority reminded that in order to be granted with the preferential access to the EU market as part of a free trade area between Ukraine and the EU, a company must confirm the origin of goods from Ukraine and receive the EUR.1 movement certificate.
The State Fiscal Service has been issuing these documents since 2016 free of charge for each consignment of goods when exported to the EU. At the same time, the status of an authorized exporter lifts the requirement to receive the certificate, the authority said.
In addition, the requirement for having the EUR.1 movement certificate does not apply to goods with a total invoice value no higher than EUR 6,000, and also, if these are goods to which the EU applies a zero import duty rate.