PHARMA MARKET
PHARMACEUTICAL MARKET NEWS IN JANUARY 2018
Biofarma Plasma is Allowed to Export Blood Preparations in 2018
The CMU granted to Biofarma Plasma special permission for sale outside Ukraine of components of donor blood and preparations made from donor blood and its components .
Biofarma Plasma is a part of Biofarma Complex and is owned by Cypriot company Niobera Investments Limited , which belongs to Biofarma ’ s President Konstantin Efimenko and Vasyl Khmelnytsky .
Croatian Authority Granted the GMP Certificate to Farmak
Agency for Medicinal Products and Medical Devices of Croatia ( HALMED ) had inspected the production facilities of Ukrainian company Framak and approve the GMP conformity . The approval allows Framak to sale its production on the Croatian market .
Framak retained the first position on Ukrainian pharmaceutical market in 2017 . It also was the only pharmaceutical company among TOP-100 biggest tax payers in Ukraine in 2017 . The company transferred to the budget UAH 526.5 mio .
BCPP Won The UNICEF Tender To Deliver Pediatric Oncohematology Products
JSC Scietific and Production Center Borshchahivskiy Chemical Pharmaceutical Plant ( BCPP ) has won the tender of the MOH through the UNDR program for the supply of two oncohematological drugs – Ondansetron ( ondansetron ) and Cebopim ( cefepime ) for about UAH 550 ths . According to the contract BCCP had provided all products in autumn 2017 .
The simplified registration procedure had been introduced by the government in May 2016 , but the lack of regulation didn ’ t allow to use it . In Dec 2017 , the MOH and the SEC in cooperation with business associations have elaborated the legislation framework to fully launch the procedure .
The simplified registration envisages registration in 17 days of drugs , which had passed all stages of the quality control in the countries with strict regulatory requirements ( the USA , the EU countries , Japan , Switzerland , Australia and Canada ).
Registration of Disinfectants in Ukraine Stopped
The Union of Organizations of Employers of Medical and Microbiological Industry of Ukraine appealed the President of Ukraine and other officials asking to resolve the situation with state registration of disinfectants in Ukraine . The legal collision emerged in 2016 after the reorganization of the State Sanitary and Epidemiological Service of Ukraine ( SSES ) and transferred of its functions to the State Service for Food Safety and Consumer Protection ( SSFSCP ). However , the authority to issue the certificates on registration of disincentive preparations was not transferred , so the registration and re-registration of such products in Ukraine stopped since then .
On Apr 2017 , the MOH developed the Draft Resolution of the Cabinet of Ministers to transfer the authorities to the MOH , but in Nov it was withdrawn from the agenda of the government ’ s meeting . According to the Union , the collision caused that above 60 disinfectant , and antiseptic drugs can ’ t pass the registration / re-registration , and some manufacturers stopped producing such drugs .
Two Drugs Registered Under the Simplified Procedure
The State Expert Center ( SEC ) approved the registration of two new preparations under the simplified procedure . The drugs are produced in USA and are dedicated to for anesthesia during high-tech operations .
Issue 29 Jan 2018 page 05