Prague, 20 June 1016 – The Prague office of Baker & McKenzie recently hosted the latest in a series of workshops on hot topics and issues that pharmaceutical companies face when doing business in the Czech and Slovak markets. As of 1 July 2016, the newly adopted Contracts Registry Act will come into force, which…
Patients and clinicians need greater regulatory transparency to make informed decisions about treatment. Medical devices approved first in the European Union (EU) are associated with a greater rate of safety issues, finds a study published by The BMJ. Clinical trial results for many new medical devices that could guide treatment decisions also remain unpublished or…
The PSUR repository is a single, central platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU. The PSUR Repository provides an important simplification for marketing authorisation holders allowing them to send all PSURs and related submissions to a single recipient. It also facilitates the assessment…
The BNT Baltic Pharma Law Survey 2015 provides actionable insights into the pharmaceutical regulatory and competition law, pricing, reimbursement and other requirements that are crucial for doing business in the Baltic states. PharmaLawSurvey2015_TheBalticStates
The European Council’s Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were released. Following a legal-linguistic review of the two documents planned for September, the Council…
According to estimates from Poland-based market research group PMR, Poland will be the most rapidly developing… In order to access this content you need to be logged into the site and have an active subscription or trial subscription. Please login, take a free trial or subscribe in order to continue reading. A trial subscription will give…
On 22nd April 2016, in Vilnius, Lithuania, EFPIA Director General Richard Bergström and Lithuanian Minister of Health Juras Pozela discussed the implementation of the Stability Agreement concluded between the industry and the Lithuanian authorities in 2014, and running until 2016. They furthermore signed a letter of intent providing for a new agreement for collaboration in…
Since the breakup of the Soviet Union, the former Soviet republics have been on a quest for independent development. At the same time, modern trends in international relations and inter-dependence of the post-Soviet economies, once part of a common and centralized economic complex, have prompted these nations to find ways to work together and integrate…
The Serbian economy ministry launched a tender process for the sale of 25% of state-controlled pharmaceutical giant Galenika on April 4, setting the starting price at just €7mn. Galenika was originally listed as one of 502 public companies supposed to be privatised by the end of 2015. However, it was among 17 companies of strategic…
Foreign companies show interest in projects to develop Belarus’ pharmaceutical industry, Head of the Belarus President Administration Alexander Kosinets said during his working visit to Vitebsk Oblast on 19 March, BelTA has learned. The official paid a visit to the veterinary drugs company BelVitunifarm to discuss the progress in the implementation of an investment project…