Regulatory Consulting in Central & Eastern Europe
NEWS & ANALYTICS
Reform of pharmaceutical regulation in Kazakhstan As of the end of 2017, active work on legislation change and update is going on in Kazakhstan in the area of healthcare and pharmaceutical business. Such legislative activity is aimed at harmonizing the laws of the Republic of Kazakhstan...
Russia and Bulgaria signed cooperation agreement Last week, on July 10, 2018, in Sofia VladislavShestakov–Director of the State Institute of Drugs and Good Practices, Deputy Head of the State GMP Inspectorate met with Professor AssenaStoimenova, Executive Director of the Bulgarian Drug Agency (Medicines Agency of the Bulgarian Health Ministry).
Aurobindo Pharma to acquire Apotex’ businesses in Poland, Czech Republic, the Netherlands, Spain and Belgium Aurobindo Pharma announced that its wholly owned step-down subsidiary, Agile Pharma B. V. (Netherlands) has entered into an agreement on 13 July 2018 to acquire commercial operations and certain supporting infrastructure in five European countries viz. the Netherlands, Belgium, Spain, Poland and ...
Slovenia and Romania are the Fastest Growing Markets in Europe Whilst the latest European Commission 2018 economic growth forecast for the EU stands at 2.3%, a large group of Eastern European countries clearly outpaces its European peers. Slovenia, Romania and Bulgaria lead the pack as shown on the chart below. Growth in the above CEE countries is forecast to ...
Bulgaria’s Sopharma Trading to grow operations in Serbia SOFIA (Bulgaria), June 22 (SeeNews) - Bulgarian drug distributor and retailer Sopharma Trading [BUL:SO5] plans to expand its operations on the Serbian market and to become a strategic investor in Southeast Europe (SEE), it said. Sopharma Trading is planning to implement its successful diversified...
Sun Pharma enters Azerbaijani market Azerbaijan’s Sumgait city has hosted the groundbreaking ceremony of the first plant for the production of solid drugs. The ceremony was attended by Azerbaijan’s Economy Minister Shahin Mustafayev. During the event, it was noted that products of the plant, which is being built by India’s Sun Ph...
Poland might not be the first place you associate with biotech, but the country is becoming an emerging hotspot for pharmaceutical companies and biotech startups. Although Poland has a very strong scientific base in life sciences and medicine, it has not developed a vibrant biotech or medtech sectors. Until recently, no truly innovative products from Poland have been introduced to the global market. The pharmaceutical industry has traditionally been based on ...
Czech Republic mulls new reimbursement rules for medical devices The Czech Health Ministry prepared draft amendments to the Public Health Insurance Act, which will introduce new reimbursement rules for medical devices, the Ministry said. The new rules are expected to come into force in January 2019, replacing current regulations that were contested by the Czec...
Medicines rose in price in Kazakhstan Medicines in Kazakhstan rose by 7% in 2018 Q1, Energyprom.kz reports. According to 2018 first quarter results, prices for pharmaceutical products rose 2% compared to the previous quarter and by 6.6% on-year. The most noticeable annual price rise was recorded in the hormonal drugs segment - by ...
Lithuania – Update on ‘Sunset Clause’ Requirements for Medicinal Products The State Medicines Control Agency on the ground of market monitoring data has compiled the list of medicinal products authorized in the Republic of Lithuania which more than for three years had not been supplied to the Lithuanian market. Following Part 7 Article 14 of the Law on Pharmacy in the ex...
New payment requirements of a Bulgarian Drug Agency In February 2018, the Bulgarian Drug Agency (BDA) announced new requirements for fee payments which are important for all applicants, marketing authorisation holders and their representatives. When requesting an administrative service for marketing authorization/registration, variations, renewals o...