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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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15 June 2021
New GDPR Code of Con­duct ap­proved for Cloud In­fra­struc­ture Ser­vice Pro­viders
The European Data Pro­tec­tion Board (EDPB) and the French Data Pro­tec­tion Au­thor­ity (CNIL) ap­proved the CISPE Data Pro­tec­tion Code of Con­duct of Cloud In­fra­struc­ture Ser­vice Pro­viders in Europe (CISPE...
04 June 2021
Video­con­fer­ence or­al pro­ceed­ings be­fore The European Pat­ent Of­fice (G1/21)
The European Pat­ent Of­fice (EPO) was due to hear the re­fer­ral in G1/21 on Fri­day 28 May 2021 con­cern­ing the ques­tion of wheth­er the con­duct of or­al pro­ceed­ings in the form of a video­con­fer­ence is com­pat­ible...
01 June 2021
Some leaks can­'t be fixed
“Con­fid­en­tial in­form­a­tion is like an ice cube... give it to the party who has no re­fri­ger­at­or or will not agree to keep it in one, and by the time of the tri­al you have just a pool of wa­ter.” This...
14 May 2021
Re­cord­ing an as­sign­ment at the European Pat­ent Of­fice
Doc­u­ment sign­ing has presen­ted nov­el chal­lenges in the new re­mote-work­ing en­vir­on­ment. Re­cord­ing an as­sign­ment at the European Pat­ent Of­fice (EPO) can be straight­for­ward provided that the form­al re­quire­ments...
13 May 2021
Can­nabis law and le­gis­la­tion in Slov­akia
Med­ic­al use It is not per­mit­ted to grow, im­port or sell can­nabis for med­ic­al use in Slov­akia. Re­cre­ation­al use It is pro­hib­ited to pro­duce, im­port or sell re­cre­ation­al can­nabis in Slov­akia. Breach of...
05 May 2021
Com­pet­i­tion law en­force­ment in the phar­ma­ceut­ic­als sec­tor in Slov­akia
1. Is there any spe­cif­ic reg­u­lat­ory frame­work that deals with com­pet­i­tion reg­u­la­tion in the phar­ma­ceut­ic­al sec­tor in your coun­try? There is no ex­clus­ive com­pet­i­tion reg­u­lat­ory frame­work re­lated to the...
Comparable
04 May 2021
With Il­lu­mina ac­tion, court to test EU Com­mis­sion's new mer­ger re­fer­ral...
On 29 April 2021, the US life sci­ences com­pany Il­lu­mina con­firmed that it filed an ac­tion be­fore the EU courts ask­ing for an an­nul­ment of the European Com­mis­sion’s de­cision of 19 April 2021 to ac­cept...
20 April 2021
COV­ID-19 vac­cin­a­tion and test­ing in Slov­akia - em­ploy­ment law per­spect­ive
Vac­cin­a­tion 1. What op­tions does the em­ploy­er have to en­cour­age em­ploy­ees to be vac­cin­ated? Can the em­ploy­er provide a fin­an­cial in­cent­ive to em­ploy­ees?  There are no man­dat­ory rules. Any fin­an­cial...
Comparable
06 April 2021
EU is­sues draft of Di­git­al Mar­kets Act aimed at cre­at­ing a new and fair...
The European Com­mis­sion has pub­lished a draft pro­pos­al for a new com­pet­i­tion law frame­work for large on­line plat­forms, called the Di­git­al Mar­kets Act (DMA). The Com­mis­sion pro­posed the DMA due to the...
23 March 2021
The En­larged Board of the European Pat­ent Of­fice has giv­en a mo­ment­ous...
The En­larged Board of the European Pat­ent Of­fice heard or­al ar­gu­ments in Ju­ly 2020 con­cern­ing pat­entab­il­ity of a com­puter soft­ware in­ven­tion.  This rare event was video streamed to over 1600 pat­ent stake­hold­ers...
19 March 2021
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”);Act No...
05 March 2021
New EPO Guidelines on an­ti­body claims provide fur­ther clar­ity for ap­plic­ants
In­tro­duc­tion The EPO has now pub­lished their re­vised Guidelines for Ex­am­in­a­tion 2021[1] which con­tain new sec­tions de­tail­ing EPO prac­tice in re­la­tion to an­ti­bod­ies for the first time, en­ter­ing in­to force...