ArticleNew Registration Rules And Calculation Methodology For Maximum Manufacturer's Sale Prices For Vital And Essential DrugsOn October 1, 2015, the new versions of the following regulations will come into legal force and effect:RussiaFood, Drugs, Healthcare, Life SciencesDentons
ArticleChanges In The Regulation Of Trading Activities In RussiaThe Federal Law 'On the Fundamentals of State Regulation of Trade Activities in the Russian Federation' (hereinafter - Trading Activities Law) clarifies the definition of trade network...RussiaCorporate/Commercial LawGRATA International
ArticlePharma Patents: Healing The RightsScientists synthesize thousands of substances that could potentially become medicines.RussiaIntellectual PropertyGorodissky & Partners
ArticleFocusing On The Genetic Construct When Applying For A Drug Patent Could Be Key To Obtaining ProtectionRussia has a lively pharmaceutical market, in which it is possible to obtain comprehensive patent protection for products and methods that are aimed at treating and diagnosing specific diseases.RussiaIntellectual PropertyGowling WLG
ArticleImport Substitution In The Pharmaceutical And Medical Industries In Russia: Legislative Developments And InitiativesImport substitution (a significant increase of the share of medicines and medical devices of Russian origin) in the pharmaceutical and medical industries is envisaged by...RussiaFood, Drugs, Healthcare, Life SciencesGRATA International
ArticleRecommendations Of The Federal Anti-Monopoly Service Of Russia For The Development And Application Of Commercial Policies At The Markets Of Medicines And Medical ProductsThe basic provisions of the Recommendations that are worth to pay attention to are discussed below. RussiaAntitrust/Competition LawGRATA International
ArticleSecond Medical Use Inventions – Russian And Eurasian Patent LegislationWhen patenting inventions in Russia, one potential route is granting a patent for an invention relating to a well-known product used for a new purpose, the so-called ‘second medical use invention'.RussiaIntellectual PropertyGorodissky & Partners
ArticleChanges To The Rules For Forming Lists Of Medicines Become EffectiveOn October 29, 2018, the Government of the Russian Federation approved the changesRussiaFood, Drugs, Healthcare, Life SciencesDentons
ArticleSports, Athletes, And (Legal) Drugs: A Guide To Therapeutic Use Exemptions For Banned SubstancesTherapeutic Use Exemptions (TUEs) first hit the headlines back in 2016 when Russian hackers released medical information about athletes who had applied for such exemptions from the International Olympic Committee (the "IOC").RussiaMedia, Telecoms, IT, EntertainmentGowling WLG
ArticleCOVID-19 And New Legal Challenges For Pharma MarketThis year events relating to global pandemics of COVID-19 for sure had impact on various issues of human civilization. RussiaFood, Drugs, Healthcare, Life SciencesGorodissky & Partners
ArticleNaming, Registering And Advertising Pharmaceutical Trademarks In RussiaThe pharmaceutical industry is currently one of the Russian economy's high-tech development priorities. According to analytical data, in 2019 the Russian commercial drug market was worth Rb84.3 billion (approximately...RussiaIntellectual PropertyGorodissky & Partners
ArticleStrategies For Pharma Patent LitigationAccording to official statistics, the pharmaceutical industry in Russia was among the industries that showed maximum growth in 2020.RussiaIntellectual PropertyGorodissky & Partners
ArticleRussia, February 2021: Update On Pharma Regulatory Issues (Video)On December 15, 2020, in the first reading, the Russian State Duma approved amendments to Article 1360 of the Civil Code "Use of an Invention, Utility Model or Industrial Design in the Interests of...RussiaIntellectual PropertyGowling WLG
ArticleLife Sciences. Major Russian Legal Changes In The Second Half Of 2017The Russian government has introduced a risk-oriented approach for scheduled inspections in the healthcare industryRussiaFood, Drugs, Healthcare, Life SciencesDentons
ArticleРоспатент Объединил Все Сведения О Фармацевтических Патентах, Действующих На Территории ЕАЭС В Единый Реестр Фармакологически Активных ВеществРоссия в рамках ЕАЭС создаст единый реестр фармакологически активных веществ, охрRussiaIntellectual PropertyLegalmax Law Firm
ArticleChanges In The Regulatory Control Of The Pharmaceutical Market - Q1 2016 ReviewUntil January 1, 2017, for confirming the state registration of a foreign medicinal product, it is permitted to present a certificate of GMP compliance to the applicable GMP standards in the country of origin...RussiaFood, Drugs, Healthcare, Life SciencesDentons
ArticleChanges In The Regulatory Control Of The Pharmaceutical Market. Q1 2016 ReviewUntil January 1, 2017, for confirming the state registration of a foreign medicinal product, it is permitted to present a certificate of GMP compliance to the applicable GMP standards in the country of origin.RussiaFood, Drugs, Healthcare, Life SciencesDentons
ArticleChanges In The Federal Law ‘On Medicines’ Circulation’The Federal Law dated 22 December 2014 No. 429-FZ to become effective from 1 July 2015, introduces important amendments to the Federal Law dated 12 April 2010 No. 61-FZ ‘On Medicines’Circulation’.RussiaFood, Drugs, Healthcare, Life SciencesGRATA International
ArticleLegal analysys of the Draft Law of Ukraine "On the Newest Food Products"Илья Костин, партнер ЮК «Правовой Альянс»RussiaFood, Drugs, Healthcare, Life SciencesLegal Alliance Company
ArticleTemporary Prohibition Of Turnover Of Medicines (Quarantine) In Ukraine: The Legal Grounds And Practice AspectsWe received information on special representative of the President of Ukraine on child rights procurement of drugs used for the treatment and prevention of diseases in children, with the purpose of checking their quality.RussiaFood, Drugs, Healthcare, Life SciencesLegal Alliance Company