Life sciences
Alerts
08February2024
Amendments have been made to the law on the circulation of medicines with a view to harmonising it with EAEU legislation
Federal Law No. 1-FZ was adopted on 30 January 2024 to amend Law No. 61-FZ “On the circulation of medicines”. The amendments are designed to harmonise Russian legislation with the unified requirements for the circulation of medicines on the EAEU market and to improve current regulation.
03July2023
From 1 September 2023, the labelling of pharmaceutical products will become mandatory
From 1 September 2023, it will be mandatory to label with means of identification biologically active supplements, skin sanitisers, individual types of medical products, and other goods.
16March2023
An experiment has started in online trade in Rx-medicines
An experiment started on 1 March 2023 regarding distance trade in prescription medicines.
21October2022
Martial law status. Restrictions for business and individuals in Russian regions
Pepeliaev Group advises that, on 19 October 2022, Presidential Decrees No. 756 and No. 757 came into force. They introduced martial law as of midnight of 20 October 2022 on the territories of Donetsk People’s Republic and Lugansk People’s Republic, as well as Zaporozhye and Kherson regions, and established special regulation in a number of other constituent entities of the Russian Federation.
05August2022
New developments in legislation on special economic measures: what the participants on the pharmaceuticals market should anticipate
Starting from 25 July 2022, federal laws dated 14 July 2022 No. 272-FZ and No. 273-FZ came into force, which amend the public procurement rules, including in the sphere of pharmaceuticals and medical items if special state security measures are introduced.
04August2022
A draft law has been submitted to the state duma for the online trade of RX medicines
On 29 July 2022, a draft law was submitted to the State Duma for an experiment to be conducted by introducing remote trading in prescription medicines.
11March2022
Changes in the state procurement procedure for medicines, medical devices and consumables
Pepeliaev Group advises that Federal Law No. 46 dated 8 March 2022 came into force on 8 March 2022. The specified federal law amends, among other things, the regulation of purchases of medicines and medical devices.
20September2021
The new import procedure for unregistered medicines
Pepeliaev Group advises that a new procedure has come into force for obtaining a permission to import unregistered medicines into the Russian Federation.
04May2021
Grounds for “compulsory licensing”* have changed
Law firm Pepeliaev Group advises that Federal Law No. 107-FZ “On amending article 1360 of Section Four of the Civil Code of the Russian Federation” (the “Law”) was adopted on 30 April 2021, which has introduced the following amendments to article 1360 of the Civil Code.
04May2021
The regulation of the circulation of medical products is changing
Pepeliaev Group advises that on 30 April 2021 Federal Law No. 128-FZ “On amending the Federal Law “On the fundamentals of health protection in the Russian Federation” and articles 12 and 22 of the Federal Law “On licensing individual types of activity” was adopted, which substantially amends the regulation of the circulation of medical products.
15April2020
An exemption from customs duties and VAT for goods imported into the Russian Federation to guard against and counteract the spread of the Coronavirus infection
Pepeliaev Group advises that the Russian Government has adopted its Resolution No. 419 dated 2 April 2020 “On the implementation of Decision No. 21 of the Board of the Eurasian Economic Commission dated 16 March 2020 and on amending the List of medical goods whose sale within the Russian Federation and import into the Russian Federation and other territories falling under its jurisdiction are not subject to (are exempt from the application of) VAT”.
Pepeliaev Group advises that the Russian Government has adopted its Resolution No. 419 dated 2 April 2020 “On the implementation of Decision No. 21 of the Board of the Eurasian Economic Commission dated 16 March 2020 and on amending the List of medical goods whose sale within the Russian Federation and import into the Russian Federation and other territories falling under its jurisdiction are not subject to (are exempt from the application of) VAT”.
13April2020
The state has approved distance trading in medicines
Pepeliaev Group advises that a law has been adopted that allows distance trading in over-the-counter medicines, as well as in prescription medicines for the period of the pandemic/emergency.