Life Sciences & Healthcare

The obligation to provide adequate and continuous stocks of pharmaceuticals in Romania

August 2017 - The Romanian Ministry of Health has recently issued an order on the obligation to provide adequate and continuous stocks of pharmaceuticals (the “ Order ”), which aims to clarify the implementation of this obligation and to provide...

Czech Republic: Controversial amendments aim to limit re-export of medicinal products

March 2017 - The long-awaited amendment to the Act on Medicinal Products (Act no. 378/2007 Coll., as amended) (the “ Amendment ”) was adopted. It (i) introduces a new legislative framework for re-export of medicinal products; (ii) imposes new measures...

Kinstellar advises TEVA on the USD 40.5 billion global acquisition of Actavis Generics

October 2016 - Kinstellar has advised its client TEVA, the world’s largest generic drug company by sales, on the Bulgarian, Czech, Hungarian and Slovak aspects of its USD 40.5 billion global acquisition of Actavis Generics, the generics division of...

Romanian Competition Council publishes report on the pharmaceutical sector and announces the launch of Novartis investigation

June 2016 - On 1 June 2016 the Romanian Competition Council (‘ RCC ’) published a much-anticipated report detailing the results of its investigation into Romania’s pharmaceutical sector. The 499-page report is the culmination of the investigation...

Re-exports targeted by an amendment to the Medicinal Products Act, in the Czech Republic

March 2016 - From 1 March 2016, the Czech Parliament will start discussing a long-awaited amendment to the Act on Medicinal Products (Act no. 378/2007 Coll., as amended) (the “ Bill ”). The Bill introduces an entirely new legislative framework for...

Kinstellar Prague office recognised as the top-tier Czech firm in the area of life sciences

November 2015 - Kinstellar is pleased to announce that its Life Sciences practice group in Prague has been ranked by LMG Life Sciences – a guide to the leading life sciences firms and attorneys in Europe and North America – among the top-tier law...

Public debate on the binding commitments offered by GlaxoSmithKline in an investigation for abuse of dominance, in Romania

September 2015 - On 2 September 2015, the Romanian Competition Council (“ RCC ”) published on its website a series of commitments proposed by GlaxoSmithKline SRL (“ GSK ”) in the context of the RCC’s investigation regarding a potential abuse...

New Czech law on medical devices

March 2015 - Long-awaited new legislation on medical devices comes into effect in the Czech Republic on 1 April 2015. In many respects, the new law brings fundamental changes throughout the industry. In particular, manufacturers, importers and distributors...

Bulgarian Constitutional Court repeals grounds for blocking parallel exports of medicines

February 2015 - In January 2014, amendments to the Bulgarian Act on Medicinal Products in Human Medicine introduced a notification regime for exports of reimbursed drugs from Bulgaria. Under the amendments, wholesalers were required to notify in advance...

The Serbian Competition Authority confirms fines against 12 pharmaceutical companies for entering into a restrictive agreement (Hemofarm)

May 2012 - On 26 January 2012 the Commision for the Protection of Competition of the Republic of Serbia (the “Competition Authority”) issued a decision setting the amount of fines for 12 pharmaceutical companies (Hemofarm a.d., Galenika a.d., Zdravlje...