Key Changes to the Law on Circulation of Medicines
The legislative novelties are primarily aimed at harmonizing national regulation and rules established in the EAEU unified market.
According to the Group-IB research, last year the amount of publicly released databases of Russian companies six times outnumbered those unlawfully made public in 2021. At the same time, special provisions, regulating liability for personal data leaks, are not foreseen neither in the Code of Administrative Offenses of Russia nor in the Criminal Code.
Therefore, on 4 December 2023, the draft laws No. 502104-8 “On Amendments to the Code of Administrative Offences of the Russian Federation” (“draft law No. 502104-8") and No. 502113-8 “On Amendments to the Criminal Code of the Russian Federation” (“draft law No. 502113-8”), providing toughening liability for personal data leakage, were submitted to the State Duma.
According to the explanatory notes to these draft laws, currently existing liability is disproportional and incomparable to the potential social harm which can personal data leakage result in.
Lidings experts have authored the The Pharma Legal Handbook — practical directory focused on the key aspects of legislative regulation of pharmaceutical industry in Russia. The Handbook covers major issues linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents in Russia and is a must-have for any company operating in the country or looking to enter the market.
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