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Life Sciences & Healthcare Law Firm in Slovakia

We work with and have established long-term relationships with the top 100 life sciences companies in the areas of pharmaceuticals, medical devices, biotechnology, agriculture and food, including the top 20 global pharmaceutical companies and nine out of the top ten global medical device companies. Our life sciences teams in Central and Eastern Europe advise leading global business groups in the sector on transactions, commercial agreements, compliance, investigations and litigation, very often across multiple jurisdictions in the region and beyond.

We can help you to navigate the regulatory landscape and to ensure compliance with both local laws and global policies.

With over 480 international specialist lawyers across CMS and the support of the Lifesciences Asia-Pacific Network (LAN), we understand the scientific and commercial as well as the legal imperatives affecting your life sciences business. Our experts, many of whom have worked in-house in your sector, have developed a shared capability in the areas of pharmaceuticals, biotechnology, medical devices and diagnostics. With active memberships in major industry associations such as the ABPI, ABHI, BIVDA, PAGB, EUCOMED and EFPIA, we help shape the legal frameworks impacting the life sciences sector. We regularly advise our clients on their day-to-day operational needs such as support with advertisement and promotion of medicine, public sector procurement, pricing and reimbursement, patent enforcement, commercial and clinical trial agreements as well as regulatory advice.

Our Slovak office works intensively with companies from the life sciences sector. Our team in Bratislava provides comprehensive advice on regulatory issues and compliance with statutory provisions, as well as on issues specific to the sector, such as the labelling and advertising of pharmaceutical and cosmetic products and the registration of drugs and medicines. Furthermore, our experts will provide you with support in obtaining permissions to trade in medicines and advice on the various aspects of clinical testing.


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21/05/2024
Consultation of the European Commission on Vifor's commitments concerning...
In response to the Preliminary Assessment stating the potential abuse of its dominant position, Vifor proposed several commitments to rectify the potential competition law infringement. The European Commission...
16/05/2024
A broader interpretation of "substance or composition" - good news for...
A recent decision from the EPO Boards of Appeal (T 1252/20) potentially paves the way for more diverse products to be patentable in Europe using the medical use claim format.The back­ground:Art­icle 53(c)...
08/05/2024
Pharmaceutical advertising regulation and medical device advertising in...
1. Which laws are applicable regarding advertising of medicines and medical devices? The primary legal source is Act No. 147/2001 Coll. on Advertisement, as amended (“Act on Ad­vert­ise­ment”), in which...
11/04/2024
Navigating clinical trial disclosures: No reasonable expectation of success...
Recent EPO Board of Appeal decision T 1437/21 adds to a growing number of decisions concerning the patentability of second or further medical use inventions where the prior art relates to a clinical trial...
27/03/2024
Cannabis law and legislation in Slovakia
Medical use It is not permitted to grow, import or sell cannabis for medical use in Slovakia. However, it is now permitted to grow cannabis for the research purposes, subject to approval granted by the...
25/03/2024
Patentability of inventions relating to diagnostic methods at the EPO
Under Article 53(c) of the European Patent Convention (EPC), diagnostic methods practised on the human or animal body are excluded from patentability. The purpose behind this exclusion is to avoid patent...
30/01/2024
What’s in a name? Updated EMA guideline on naming medicinal products processed...
The updated EMA Guideline on the acceptability of names for human medicinal products processed through the centralised procedure was adopted by CHMP in December 2023 and came into effect on 1 January...
08/01/2024
Adapting to the new EU Data Act: implications for medical devices and other...
In recent years, the European Commission developed a European data strategy, which aims to create a single European market in which data can circulate freely. As the European Commission has emphasized...
18/12/2023
Digital health apps and telemedicine in Slovakia
Digital Health Apps/Software 1. How is the software within digital health apps classified in your jurisdiction, and what regulation(s) apply? Software within digital health apps (the “DHA Software”)...
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08/12/2023
COP28: Global Health Under the Spotlight
Health took centre stage at the first ever ‘Health Day’ at COP28 on 3 December. The program focused the attention of world leaders on the profound public health-related issues stemming from climate...
08/11/2023
CMS Life Sciences Vital Signs, Winter 2023
2023 has seen some significant legal developments impacting the life sciences industry, and as we look ahead to 2024, there are several important developments which we would like to keep our clients informed...
15/08/2023
AI in healthcare inventions – technical or not technical?
SummaryRecent European Patent Office (EPO) Board of Appeal case T 1910/20 sits among a number of decisions regarding the discussion of what constitutes technical character in the field of healthcare...