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WIPOTEC-OCS blog on the subject of serialisation

Russia Moves the Deadline on Serialization of Pharmaceutical Drugs to 2020

A new Federal Law in Russia, signed by the President of the Russian Federation on December 28, 2017 and published on the following day, moves the serialization deadline to January 1, 2020. With this move, the Russian government overrides the previous implementation date (January 1, 2019) and provides pharma companies with more time to implement the legal requirements on serialization of drugs.

However, the law provides the government with the right to set intermediate periods for marking of vital and essential medicines (the list of drugs that satisfy the priority healthcare needs approved by the Government of the Russian Federation). This specifically includes medicines for Gaucher disease, multiple sclerosis, organ transplant patients etc.

You can see the original of the Federal Law No. 425-FZ of December 28, 2017 "On Amendments to the Federal Law "On the circulation of medicinal products"" here

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