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Life Sciences & Healthcare

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 150 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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01/01/2018
Good medi­cine in­stead of bit­ter pills
Bro­chure Med­ic­al Law
15 Nov 19
Brexit and data pro­tec­tion: what to do next (when you don’t know what’s...
Whilst the threat of a no-deal Brexit has been aver­ted for now, the fu­ture is by no means cer­tain. We have high­lighted some of the key is­sues for UK-based or­gan­isa­tions, and the EEA or­gan­isa­tions that...
15/12/2015
CMS Glob­al Lifes­ci­ences For­um 2015
Shap­ing the fu­ture through in­nov­a­tion and col­lab­or­a­tion
05 Nov 19
Whis­tleblow­ing Dir­ect­ive ad­op­ted by the EU Coun­cil
On 7 Oc­to­ber 2019, the EU Coun­cil ap­proved the word­ing of the "Dir­ect­ive of the European Par­lia­ment and of the Coun­cil on the pro­tec­tion of per­sons who re­port breaches of Uni­on law", also known as the...
19/02/2015
Un­der the Mi­cro­scope
13 Sep 19
SPC Double Whammy - In­ter­pret­ing Art­icle 3(a) of the SPC Reg­u­la­tion
Sum­mary At the end of June, the CJEU heard the joint re­fer­rals from the Ger­man Bundes­pat­ent­gericht (case C-650/17) for Mer­ck’s sitaglipt­in product and from the Eng­lish Court of Ap­peal for Searle’s...
13 Jun 19
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...
30 May 19
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...
27 Mar 19
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...
24 Aug 18
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,...
18 May 18
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...
17 Apr 18
NGOs can ask the Com­mis­sion to re­view its de­cision on ge­net­ic­ally...
The Gen­er­al Court de­cided in its de­cision of 14 March 2018 that non-gov­ern­ment­al or­gan­iz­a­tions (“NGOs”) can ask the Com­mis­sion to re­view its de­cision on au­thor­iz­ing the pla­cing on the mar­ket of ge­net­ic­ally...