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Update: Russia sets 2020 deadline for pharma track and trace

Update:The draft law was signed by President Putin on December 28 and published officially the following day.

A new draft law in Russia will set an implementation date of January 1, 2020 for tracking and tracing of medicines – although some high priority drugs could see an earlier deadline.

Seven special cases– including a list of essential medicines as well as drugs for Gaucher disease, pituitary diseases, haemophilia, haematological malignancies, multiple sclerosis and organ transplant patients – may be subject to an earlier implementation deadline at the discretion of the government, along with a category of 'essential' medicines and potentially also high-cost drugs,

Marketing application holders for medicinal products must file registration information for the track-and-trace system with the Russian governing body by January 1, 2019. Other details of the regulations can be seen in our review article here.

The third reading of the draft law (link to page in Russian) making its way through the Russian parliament (Duma) and was adopted on December 22. The government will set up a working group to monitor the progress with implementation and has said it intends to hold review meetings in mid 2018.


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