laboratory shelfs with bottles and vials

In the last decade, it has become increasingly complex and costly to obtain marketing authorisation. On top of this,  market access has become   more complex and difficult  because of ongoing pressure on national health budgets. Our specialised regulatory team is able to support clients facing these challenges and to help maximising commercial opportunities.

We offer extensive expertise in every phase of developing pharmaceutical products, from R&D activities to clinical trials, from marketing and selling a product to advising on late life cycle activities; for every step we offer accompanying legal advice. We can answer all your questions: whether this is regulatory, anti-corruption, public procurement  or tax related.

We also represent clients in legal proceedings related to price and reimbursement issues involving government decisions and in domestic and cross-border litigation related to commercial disputes, M&A, defending product liability claims, protecting intellectual property rights and code compliance issues.  

20/04/2020
CMS Ex­pert Guide to ad­vert­ising of medi­cines and med­ic­al devices
 Ad­vert­ising of phar­ma­ceut­ic­als and med­ic­al devices is a chal­len­ging area for the Life Sci­ences and Health­care in­dustry.The leg­al frame­work is con­stantly chan­ging. Due to very few laws on this area, there are sig­ni­fic­ant dif­fer­ences between jur­is­dict
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17/09/2021
Vac­cine com­pens­a­tion re­gimes in the Neth­er­lands
1. Are COV­ID-19 vac­cin­a­tions ob­lig­at­ory in your jur­is­dic­tion? Are you ex­pect­ing any le­gis­lat­ive changes to en­able man­dat­ory vac­cines for all or cer­tain people (e.g. health­care pro­fes­sion­als, pub­lic ser­vants...
Comparable
17/02/2021
Com­puls­ory li­cens­ing in the Neth­er­lands
1. What is the defin­i­tion of com­puls­ory li­cens­ing? There is no spe­cif­ic leg­al defin­i­tion for com­puls­ory li­cens­ing un­der Dutch law. However, the Dutch Pat­ents Act 1995 con­tains a num­ber of re­quire­ments...
Comparable
16/02/2021
Fight­ing poor med­ic­a­tion ad­her­ence in the European Uni­on: The Grav­it­ate-Health...
Nowadays, European cit­izens can ob­tain a great amount of in­form­a­tion (on­line and off­line) about any medi­cine. However, this in­form­a­tion is in many cases un­re­li­able and dif­fi­cult to un­der­stand, en­cour­aging...
03/12/2020
With the in­tro­duc­tion of a new Phar­ma­ceut­ic­al Strategy for Europe, the...
New Phar­ma­ceut­ic­al Strategy to be a corner­stone of the European Health Uni­on The new Phar­ma­ceut­ic­al Strategy for Europe, an­nounced by the EU Com­mis­sion on 25 Novem­ber, is ex­pec­ted to be­come a main pil­lar...
07/07/2020
CMS ad­vises Im­mat­ics on the busi­ness com­bin­a­tion with Arya Sci­ences Ac­quis­i­tion...
Im­mat­ics N.V. has an­nounced the com­ple­tion of its busi­ness com­bin­a­tion with Arya Sci­ences Ac­quis­i­tion Cor­por­a­tion. The Im­mat­ics shares and war­rants are now traded un­der the sym­bol “IMTX” and the...
17/06/2020
Pod­cast: Ad­vert­ising of Medi­cines and Med­ic­al Devices
The series brings to­geth­er CMS law­yers and ex­perts to dis­cuss key in­dustry top­ics im­pact­ing, in­nov­at­ing and dis­rupt­ing the life sci­ences & health­care sec­tor.  In Epis­ode #2, Nick Beck­ett (China/Hong...
27/03/2020
Man­aging clin­ic­al tri­als un­der COV­ID-19: New EU guid­ance is­sued for spon­sors...
The COV­ID-19 pan­dem­ic has had a dra­mat­ic im­pact on European health sys­tems, whose pri­or­ity first and fore­most is the treat­ment of pa­tients suf­fer­ing from this dis­ease both in the in-pa­tient and out-pa­tient...
21/11/2019
CMS Glob­al Life Sci­ences & Health­care For­um 2019
 We have the pleas­ure to cor­di­ally in­vite you to our    on Thursday, 21 Novem­ber 2019, at 09:30 CET in Frank­furt.The For­um will provide in­sights from ex­tern­al ex­perts and CMS spe­cial­ists on four core...
02/04/2019
WLG Can­nabis Leg­al­iz­a­tion: Europe Up­date
What is the status of can­nabis lib­er­al­iz­a­tion in the Neth­er­lands, Ger­many and Spain? Pan­el­ists El­len Gielen (CMS Neth­er­lands), Jörn Witt, Susanne Pech (both CMS Ger­many) and Juan Car­los Hernanz (Cuatreca­s­as...
21/06/2018
El­len Gielen: "Al­tern­at­ives to ex­pens­ive medi­cines: the leg­al lee­way is...
It is very pos­it­ive that in the Neth­er­lands al­tern­at­ives to ex­pens­ive medi­cines are be­ing con­sidered. But from a leg­al per­spect­ive, the abil­ity to ap­ply the al­tern­at­ives is lim­ited and little at­ten­tion...
24/05/2018
SYN­LAB takes con­trol with test­ing ac­quis­i­tion
In one of last year’s most sig­ni­fic­ant deals in the life sci­ences sec­tor, CMS cli­ent SYN­LAB bought AL­con­trol, a European pro­vider of en­vir­on­ment­al test­ing ser­vices. SYN­LAB is Europe’s lead­ing pro­vider...
16/10/2017
Mov­ing times
Fol­low­ing Brexit, Bri­tain must pay to re­lo­cate the European Medi­cines Agency from Lon­don to a city with­in the EU and 19 European coun­tries are pla­cing their bids to be the next host. In­deed the EMA is...