Lab

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 and nine out of the top ten global medical device companies.

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 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.

The team offers high responsiveness, a good understanding of business, well-organised client events, focused information sharing and regular updates on legislative changes.
Chambers

With over 150 international specialist lawyers across CMS and the support of the Life Sciences & Healthcare Asia-Pacific Network (LAN), we understand the scientific and commercial 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 and EFPIA, we help shape the legal frameworks impacting the life sciences & healthcare 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.

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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Eva Schothorst - Gransier
25/11/2015
CMS Glob­al Lifes­ci­ences For­um 2015 in Frank­furt
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.
20/07/2017
Entry in­to force of EU Clin­ic­al Tri­als Reg­u­la­tion post­poned to 2019
On 16 June 2017, the European Medi­cines Agency (“EMA”) pub­lished a press re­lease1 an­noun­cing the post­pone­ment of the entry in­to force of the EU Clin­ic­al Tri­als Reg­u­la­tion of 16 April 2016. 2 It was one of the top­ics at the June 2017 meet­ing of the EMA Man­age­ment.
23/06/2017
European Com­mis­sion in­vest­ig­ates po­ten­tial ex­cess­ive pri­cing of life-sav­ing...
On 15 May 2017, the European Com­mis­sion opened a form­al in­vest­ig­a­tion in­to the pri­cing of medi­cines. [1] The Com­mis­sion is in­vest­ig­at­ing wheth­er As­pen Pharma has been im­pos­ing ex­cess­ive pri­cing that con­sti­tutes an ab­use of dom­in­ant po­s­i­tion in vi­ol­a­tion of European.
22/06/2017
The Court of Justice of the EU held that the Bel­gian gen­er­al pro­hib­i­tion...
On 4 May 2017, the Court of Justice of the EU answered sev­er­al pre­ju­di­cial ques­tions sub­mit­ted by the Bel­gian tribunal of first in­stance re­gard­ing the ad­vert­ising of the ser­vices of dent­ists. In this judg­ment, the Court held that the Bel­gian le­gis­la­tion im­pos­ing.
21/06/2017
The Ver­dict - Round-up of cor­por­ate crime de­vel­op­ments across CMS
We are pleased to send our new is­sue of The Ver­dict, an at-a-glance round-up of re­cent leg­al de­vel­op­ments in re­la­tion to cor­por­ate crime. In this is­sue, the spot­light is on some sig­ni­fic­ant changes to anti-cor­rup­tion laws in the Czech Re­pub­lic, in­clud­ing.
02/05/2017
New reg­u­la­tion on med­ic­al devices
In­tro­duc­tion The cur­rent leg­al frame­work for med­ic­al devices in the European Uni­on is based on the fol­low­ing Dir­ect­ives, ad­op­ted in the 1990s: §  Dir­ect­ive 90/385/EEC, act­ive im­plant­able med­ic­al devices §  Dir­ect­ive 93/42/EEC, med­ic­al devices §  Dir­ect­ive.