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Life Sciences & Healthcare

Russia

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 & healthcare business. 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 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. Equally, when you need life sciences & healthcare specialist advice for strategic agreements, planning a corporate transaction or embarking on litigation (whether product liability or otherwise), we have a team that is well versed in the industry issues to help you.

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13/09/2019
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 dar­unavir product (case C-114/18).
30/08/2019
Rus­sia to en­force "Sov­er­eign In­ter­net" Law
On 1 Novem­ber 2019, the ma­jor­ity of the pro­vi­sions of the Sov­er­eign In­ter­net Law* will come in­to force in Rus­sia. The Law’s main goal is to cre­ate an autonom­ous sys­tem that can sup­port the op­er­a­tion of the Rus­si­an seg­ment of the In­ter­net in the event of dis­con­nec­tion.
01/08/2019
E-visas to be avail­able for St. Peters­burg and Len­in­grad Re­gion
From 1 Oc­to­ber 2019*, for­eign cit­izens will be able to enter Rus­sia with single-entry elec­tron­ic visas at bor­der con­trol posts loc­ated in Saint Peters­burg and the Len­in­grad Re­gion. With this type of visa, for­eign cit­izens will only be able to travel with­in.
24/06/2019
Prices for es­sen­tial drug list medi­cines sub­ject to man­dat­ory re-re­gis­tra­tion...
On 7 June 2019, a law* es­tab­lish­ing new re­quire­ments for the re-re­gis­tra­tion of prices for es­sen­tial drug list medi­cines ("EDL medi­cines") came in­to force in Rus­sia. The law provides for the man­dat­ory re-re­gis­tra­tion of prices for all EDL medi­cines in 2019.
05/06/2019
Rus­sia of­fers visa-free entry dur­ing UEFA Euro 2020
For­eign na­tion­als plan­ning to at­tend UEFA Euro 2020 matches in Saint Peters­burg as spec­tat­ors will be able* to enter Rus­sia without a visa if they have a pass­port, a Fan ID, an en­trance tick­et for a match or doc­u­ments en­titling them to re­ceive tick­ets.
21/05/2019
New law es­tab­lishes con­di­tions for di­git­al rights in Rus­sia
On 1 Oc­to­ber 2019, the so-called ‘Law on di­git­al rights’, Fed­er­al Law No. 34-FZ dated 18 March 2019*, will come in­to force. It in­tro­duces the concept of “di­git­al rights” in­to Rus­si­an le­gis­la­tion, sim­pli­fies re­quire­ments as to the form of elec­tron­ic trans­ac­tions.
01/03/2019
New rules for cre­at­ing san­it­ary pro­tec­tion zones
Own­ers and op­er­at­ors of fa­cil­it­ies hav­ing an ex­cess­ive chem­ic­al, phys­ic­al or bio­lo­gic­al ef­fect on the en­vir­on­ment have un­til 15 March 2019 to sub­mit ap­plic­a­tions to the Fed­er­al Ser­vice for Sur­veil­lance on Con­sumer Rights Pro­tec­tion and Hu­man Well­being (“Rospo­treb­n­ad­zor”).
11/12/2018
New Rus­si­an law tight­ens the pro­ced­ure for put­ting medi­cines on the...
From 29 Novem­ber 2019, medi­cines for hu­man use will no longer be put on the mar­ket based on de­clar­a­tions of com­pli­ance and cer­ti­fic­a­tion. More com­plex qual­ity con­trol re­quire­ments will be in­tro­duced. Phar­ma­ceut­ic­al com­pan­ies will have to sub­mit doc­u­ments on.
23/11/2018
Rus­sia ad­opts re­com­mend­a­tions on drug ad­vert­ising
The Fed­er­al An­ti­mono­poly Ser­vice of Rus­sia (FAS) to­geth­er with lead­ing in­dustry as­so­ci­ations (AIPM, AR­FP and oth­ers) is­sued Re­com­mend­a­tions for ad­vert­ising over-the-counter medi­cines*, which cov­er the most com­mon vi­ol­a­tions in the field of drug ad­vert­ising,.
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.
12/07/2018
New law im­proves pro­ced­ure for re­gis­ter­ing medi­cines in Rus­sia
On 15 June 2018, Fed­er­al Law No. 140-FZ “On Amend­ments to the Fed­er­al Law ‘On the Cir­cu­la­tion of Medi­cines’”* (the “Law”) came in­to force. It sim­pli­fies the re­gis­tra­tion of for­eign medi­cines, en­hances the op­por­tun­it­ies for con­tract man­u­fac­tur­ing in Rus­sia and.
12/01/2018
New rules for de­scrib­ing medi­cines for pub­lic pro­cure­ment: more com­pet­i­tion...
The new rules* for de­scrib­ing medi­cines in tender doc­u­ment­a­tion for the pro­cure­ment of drugs by the state and mu­ni­cip­al au­thor­it­ies took ef­fect on 1 Janu­ary 2018. They are aimed at im­prov­ing the mar­ket for pub­lic pro­cure­ment of medi­cines through the ad­op­tion.