Russia creates own offshore zones?
On December 13, 2018 Russian State Duma has passed in the third reading a draft law empowering the state healthcare control (supervision) body (Roszdravnadzor) to conduct test purchases (“Draft law”).
New in procedure of introducing drugs into commercial turnover
On November 28, 2018 the Federal law of November 28, 2018 No. 449-FZ On amendments being made to separate legal acts regarding introduction of drugs into commercial turnover (the Law) was published on the official web portal of legal information.
Lidings Launches Series of Tests on Legal Regulation of Life Sciences Sector
Lidings, the leading legal advisor in Russia providing legal support to large national and international companies operating in the pharmaceuticals and healthcare sector in Russia and CIS, launces a series of specialized tests on the legislative regulation of the sector.
The procedure of registration and re-registration of maximum sale prices for drugs included in the vital and essential drugs list has been updated
On October 18, 2018 new wording of the Rules of state registration and re-registration of maximum sale prices established by drug manufacturers for those drugs, that are included in the vital and essential drugs list (the Rules and the Drugs correspondingly) has been enacted with the amendments introduced by the Russian Government Decree of 08.10.2018 No. 1207 On amendments to the Russian Government Decree of October, 29 2010 No. 865 and of September, 15 2015 No. 979 (the Decree).
The Pharma Legal Handbook: Russia
Lidings experts have authored the The Pharma Legal Handbook: Russia — practical directory focused on the key aspects of legislative regulation of pharmaceutical industry in Russia.
Lidings’ Partner Boris Malakhov Speaks at Conference on Regulatory Issues in Medical Practice
Partner of the Lidings’ Intellectual Property practice Boris Malakhov will take part in a conference entitled Regulatory Issues in Medical Practice: Regulation and Court Practice organized by Pravo.ru. The event will take part in Moscow, September 19th, 2018 in the Newsroom event hall.
Webinar on Regulation of Drugs’ Advertisement from Lidings’ Managing Partner Andrey Zelenin
Lidings Managing Partner Andrey Zelenin heading Intellectual Property practice of the firm will conduct a webinar dedicated to the Regulation of Advertisement of Drugs and Overview of Recent Cases as part of a series of webinars led by experts from the leading law firms and heads of legal of large companies, organized by Pravo.ru.
FAS of Russia expressed its opinion re selling prices for the drugs, included in Essential drug list
Federal Antimonopoly Service (FAS of Russia) has issued Letter No. АЦ/49132/18 dated 29 June 2018 in which expressed its opinion regarding selling prices for drugs, included in the List of vital and essential drugs (the “Essential drug list”). FAS indicated that these prices, when set by wholesale and retail organizations, shall be dependent on the terms of their purchase.
IP Court restrained to sell and market a generic drug until the patent expiry
On 24 April 2018 the Intellectual Property Court published its Decision in case A41 85807/2016 between Swiss-based Novartis AG and local generic Nativa LLC.