The target date for implementing obligatory pharmaceutical labelling has been changed to July 1, 2020

On December 12, 2019, the State Duma adopted the draft law on the mandatory application of identification marks to pharmaceutical packaging in the third reading, with an amendment changing the date it enters into force to July 1, 2020.

The date change is due to insufficient technical preparation of a large number of pharmaceutical companies operating in the Russian market.
Medicinal products for medical use manufactured before July 1, 2020 are subject to storing, transportation, selling, use without using identification marks before their expiry date. A similar provision applies to medicines for the treatment of costly nosologies, but only to those manufactured before December 31, 2019.

Ministry of Health of the Russian Federation developed draft amendments to the Resolution of the Government of the Russian Federation dated December 14, 2018, No. 1556 “On the Approval of the Regulation on the System of Supervision of the Marketing of Medicinal Products for Medical Use” that include the specifics of the monitoring system for placing of medicinal products into circulation, including the timetable for implementation in respect of other medicinal products for medical use (not included in the list of essential medicines and medicines for the treatment of costly nosologies).

Furthermore, according to the proposed amendments to the Resolution, during the transitional period between January 1 and July 1, 2020, manufacturers are entitled to receive free identification codes from the operator of the monitoring system. For the sale of labelled medicinal products in the first half of 2020, this may lead to substantial savings for the participants in the monitoring system for the movement of medicinal products.

Contact us

Alex Stolarsky
Partner, Rechtsanwalt, Legal & Compliance, Moscow
+7 / 495 / 956 55 57
Evgenia Sinanova
Head of Commercial Law Practice
+7 / 495 / 956 55 57

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