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Life Sciences & Healthcare

Hungary

We work with and have established long-term relationships with the top 100 life sciences & healthcare companies in the areas of pharmaceuticals, medical devices, biotechnology, agriculture and food, including the top 20 global pharmaceutical companies, the top ten global medical device companies, the largest biotechnology company and start-ups.

Our life sciences & healthcare teams in Central and Eastern Europe advise leading global business groups in the sector on transactions, commercial agreements, compliance, investigations and litigation, very quite 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.

Excellent proactive client approach (and the lawyers are) highly engaged and innovative.
Chambers, 2018

With over 300 international specialist lawyers across CMS and the support of the Life Sciences & Healthcare Asia-Pacific Network (LAN), we understand the scientific and commercial aspects, as well as the legal imperatives affecting your life sciences & healthcare 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, MedTech Europe and EFPIA , we help shape the legal frameworks impacting the life sciences & healthcare sectors.

We regularly advise our clients on their day-to-day operational needs such as support with advertisement and promotion of medicine, public procurement, pricing and reimbursement, patents, trademarks and other intellectual property, product liability, anti-trust / competition law, commercial and clinical trial agreements as well as regulatory advice and M&A.

The Life Sciences & Healthcare Team in Hungary has strong sector-specific knowledge and first-hand experience of the market, gained through secondments and working as in-house counsel at Life Sciences & Healthcare companies. The team represents the Hungarian subsidiaries of a number of market-leading companies with a continuously growing number of instructions.

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High­lights of our ex­per­i­ence in Lifes­ci­ences in Hun­gary

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30/07/2019
High­lights of our ex­per­i­ence in Lifes­ci­ences in Hun­gary
13/06/2019
SPC Man­u­fac­tur­ing Waiver to come in­to ef­fect 1 Ju­ly 2019
Gen­er­ics com­pan­ies will soon be able to man­u­fac­ture SPC-pro­tec­ted drugs for ex­port out­side the EU un­der new man­u­fac­tur­ing waiver pro­vi­sions. In the last six months of the SPC life­time, it will also be al­low­able to man­u­fac­ture gen­er­ics for stock­pil­ing for “day.
June 2019
CMS in Hun­gary 2019
30/05/2019
EPO's strict ap­proach to de­cid­ing if a com­pos­i­tion can be­ne­fit from...
The EPO Tech­nic­al Board of Ap­peal (TBA) re­viewed the law around nov­elty of use, and de­term­ined that in the case of Car­di­oPoly­mer, Inc. 's European pat­ent ap­plic­a­tion (EP07837908. 8), the claimed chem­ic­al en­tity did not qual­i­fy as a 'sub­stance or com­pos­i­tion'.
25 April 2018
CMS cor­por­ate com­pli­ance
Work­ing in part­ner­ship with you
27/03/2019
Judg­ment on Ab­rax­is C-443/17; 21st March 2019
The CJEU de­livered its judg­ment last week on the case of Ab­rax­is v Comp­troller Gen­er­al of Pat­ents con­cern­ing Sup­ple­ment­ary Pro­tec­tion Cer­ti­fic­ates (SPCs) for new for­mu­la­tions of medi­cin­al products. The Court has ruled that Art­icle 3(d) of Reg­u­la­tion No 469/2009,.
24/08/2018
Gov­ern­ment Is­sues Brexit Tech­nic­al No­tice for Life Sci­ences
On 23 Au­gust 2018, the UK Gov­ern­ment (the "Gov­ern­ment") is­sued the first wave of its tech­nic­al pa­pers de­signed to provide guid­ance to com­pan­ies to help pre­pare for a "No Deal" Brexit. In this scen­ario, there will be no "trans­ition peri­od" but rather the UK.
18/05/2018
EU Product Li­ab­il­ity Dir­ect­ive still an ad­equate tool, ac­cord­ing to...
On 7 May 2018, the European Com­mis­sion pub­lished its fifth re­port on the per­form­ance of the EU Product Li­ab­il­ity Dir­ect­ive (Dir­ect­ive/85/374/EEC) in the mem­ber states. The dir­ect­ive in­tro­duced the concept of strict li­ab­il­ity for pro­du­cers of de­fect­ive products.
25/01/2018
European Com­mis­sion as­sesses ad­equacy of Gen­er­al Food Law in food...
In an eval­u­ation of the EU le­gis­lat­ive frame­work for the 2002 Gen­er­al Food Law Reg­u­la­tion (GFLR), the European Com­mis­sion has found that this frame­work ap­pears to ad­dress most cur­rent trends, such as growth, com­pet­it­ive­ness and in­creased glob­al­isa­tion, but.
28/11/2017
REACH and Brexit – Some clar­ity gained but more cer­tainty re­quired
Sev­en­teen months after the UK Ref­er­en­dum on wheth­er to re­main in or leave the EU a num­ber of areas re­main un­cer­tain for busi­ness.   For the chem­ic­als in­dustry[i] whose products form an in­teg­ral part of our daily lives, the status of the corner­stone of the chem­ic­als.
06/11/2017
Brexit: State of play for Life Sci­ences com­pan­ies
With the UK pre­par­ing to leave the European Uni­on (EU) on 30 March 2019, life sci­ences com­pan­ies are plan­ning ahead for changes to the busi­ness and reg­u­lat­ory en­vir­on­ment. Dis­cus­sions at the EU Sum­mit on 19 Oc­to­ber 2017 primar­ily fo­cused on what are re­garded.
30/08/2017
The leg­al and reg­u­lat­ory chal­lenges of get­ting a bi­osim­il­ar product...
After a pharma view on bi­osim­il­ars was provided in the pre­vi­ous Ex­pert View column, a leg­al per­spect­ive is provided by Nick Beck­ett, man­aging part­ner at CMS Beijing and glob­al co-head of the firm­'s lifes­ci­ences sec­tor group.