Russia Regulatory Updates

This is a compilation of the recent regulatory updates from Russia. Every week, we post an update of what's new, which you can view here.

2020

• August 16: Russia's Center for Research in Perspective Technologies (CRPT) published a letter to Russian Drug Circulation Monitoring System (MDLP) participants concerning changes to aggregation reporting and new restrictions on reports 911, 914, 915, and 916 that will require companies to revise distribution processes in several situations.
• August 16: Decree No. 1079 has become law in Russia. The law implements several amendments to Decree No. 1556, the core regulation for Russia compliance. Some of those changes include updated processes for crypto code issuance and cancellation, importation, labeling options at customs warehouses, and situations where the MDLP system fails.
• July 26: A new law in Russia—No. 206-FZ—gives the government power to make rules related to non-labeled and non-serialized products produced during the country’s transition period, which ends on October 1, 2020. Roszdravnadzor also published formal rules related to the review of applications for importation of unmarked medicines.
• July 5: Russia’s new marking law has gone into effect as scheduled. The Russian government also published a new decree, No. 955, which gives stakeholders an option to request additional time to ensure that all medicines are serialized and marked before October 1, 2020.
• June 7: Deputies of the Russian State Duma met recently to review requests from industry associations for flexibility associated with the enforcement of Federal Law No. 425-FZ beginning on July 1, 2020. As a result of this meeting, the Russian State Duma is preparing recommendations to the government to include a transition period as a component of the regulation going into effect. The proposed three-month transition period would be implemented to help all companies and stakeholders achieve full compliance and ensure the smooth flow of medicines in the supply chain. It is expected that the government will review and finalize the details of the transition period within the next two weeks.
• May 31: Russian government officials report that they have successfully conducted stress and scalability tests on the MDLP, the country’s track-and-trace system. The officials report that the MDLP is ready for the upcoming July 1 compliance deadline.
• April 19: In a newly published circular, Russia’s Ministry of Industry and Trade is urging manufacturers to expand early reporting on medicines that have been serialized and crypto-coded. The government agency says this will help the rest of the supply chain test reporting requirements.
• April 12: Russian officials published Version 1.35 of the country’s regulatory compliance technical guidelines. The latest version includes new and updated technical reporting schemas.
• April 5: Russia’s regulatory authority reports that companies with the seven nosology medicines should be reporting them to the MDLP system. There have been no updates related to the impact of the COVID-19 crisis on the upcoming July 1, 2020 deadline for reporting all medicines.
• March 29: Russia’s State Duma is scheduled to discuss the COVID-19 pandemic in May. The Duma will assess the country's readiness for the July 1, 2020 deadline for compliance with new serialization regulations. Additionally, the government has published Decree 311, which paves the way for companies to pre-pay for crypto codes.

2019

• December 15: A proposed draft amendment that would adjust the compliance dates for all medicines has passed the third reading in Russia’s State Duma. The amendment is now scheduled to be considered by the country’s Federation Council. If approved, it will then be passed to Russia President Vladimir Putin for signature. Under the proposed amendment, the 12 nosology medicines produced prior to Dec. 31, 2019, and all other medicines produced prior to July 1, 2020, can be circulated in the supply chain without marking compliance until expiration.
• November 24: The initial period of commentary has ended for a Russia State Duma draft amendment that would enact a six-month transition period before enforcement of the country’s new track and trace regulations begins. The State Duma has yet to set a date for official hearings or consideration of the draft amendment.
• November 17: Russia’s State Duma published a draft amendment that calls for a six-month transition period before enforcement of the country’s new track and trace regulations take effect. The draft amendment will soon be discussed and debated in the State Duma.
• November 3: Russia’s State Duma published an amendment proposal to request a six-month transition period for the implementation of product marking and reporting regulations. No final decision has been made.
• October 20: A working group in Russia’s State Duma is considering a six-month transition period for the rollout of marking and compliance reporting requirements. The proposed transition period would begin on January 1 and end on June 30, but no final decision has been made.
• September 29: Russian authorities published an amendment to decree number 1556 that slightly modifies processes related to code acquisition, applications, usage, and payments. Going forward, either pre-payment or post-payment for crypto codes will be accepted. The government also updated tertiary-level packaging requirements. Additionally, Technical Guideline version 1.32 published with a new code_emission event added. Finally, a new draft amendment for contracting and provisioning crypto codes for foreign producers was published. 
• September 8: A new Russian government decree that modifies serialization requirements for pharmaceutical supply chain companies has been published. Among other things, Russia Government Decree No. 1118 shortens required crypto codes and sets 180-day deadlines for payments and reporting.
• July 18: CRPT published updated technical guidelines (v1.31), along with new reports that are primarily related to domestic production.
• July 7: CRPT has made v1.30 of the technical guidelines available via its website.
• June 23: The Eurasian Committee published draft requirements highlighting the use of crypto coding for the EAEC countries in alignment with Russia's requirements.
• June 16: Six industry associations published an open letter to the government asking to initiate discussions around industry readiness and a potential shift in the final deadline.

2018

• December 30: Government decree # 1577, which covers the 2019 requirements and deadlines for the 12 Nosologies medicines, was passed and published.
• December 30: Government order # 2963-p was signed, making the multi-industry system of marking and traceability of goods official. This order mandates the usage of crypto technologies in product identification. Medicines for medicinal usage were included, despite the industry's pushback and request for crypto for drugs to be removed.
• December 16: The Association of International Pharmaceutical Manufacturers (AIPM) is preparing a letter that will ask the government to shorten the size of the crypto tail to 44 characters to help ease issues occurring at packaging with the current length of 88 characters. Considering the domestic pharma support by government for longer coding, it's unclear what the response will be to this request.
• December 16: The AIPM has also stopped lobbying for an adjustment to the full implementation deadline of January 1, 2020, as that deadline is now final.
• December 9: New draft technical guidelines have introduced some significant changes into the track and trace guidelines. The 12 Nosologies deadline may end up being in October of 2019, but there has not yet been an official confirmation.
• October 21: CRPT posted a draft implementation guideline for testing the generation, application, and verification of the crypto-protected product identifier.
• October 14: CRPT is holding an educational webinar this coming week on serialization and cryptography for a multi-national pharma audience.
• September 30: CRPT published an extensive Q&A regarding their operational takeover of the central IS Marking system from the Federal Tax Service.
• September 2: A new government decree marked as N. 1018 was published that formalizes the role of CRPT in taking over as operator of the central IS Marking system from the Federal Tax Service effective 11/1. The extension of the experimental pilot to 1/1/2020 was also formalized.
• August 3: The bill to expand the 7 Nosologies list (No. 511039-7) passed in the State Duma and has now been signed and published. The list of conditions has expanded to 12 and now includes hemolytic-uremic syndrome; juvenile arthritis with systemic onset; and mucopolysaccharidosis I, II, and VI types.
• July 22: Government has stated that the 7 Nosologies deadline will be extended to Apr. 1, 2019 and that cryptographic requirements for serialization will formally be required in the upcoming Roszdravnadzor regulations that are due in August.
• July 6: Intentions were confirmed this week around the cryptographic requirements for forthcoming Russia serialization requirements and models for how companies would use cryptographic services.
• June 29: An announcement was made that the track and trace government system is being transferred from the Federal Tax Service to CRPT (a private company), with operational turnover starting Oct 1. CRPT is one of the biggest supporters of the 791/792 cryptographic mandate, adding fuel to the expectation that crypto will be coming to Russia serialization. The expectation is that Roszdravnadzor will be publishing the final regulations in August.
• February 11: Roszdravnadzor published the updated technical interface documentation and regulations for interacting with the technical services (support) of the central FTS system.
• February 4: In an update to the FTS reporting system user guide, new GTIN allocation rules were posted, which apply GTINs to sites rather than a common GTIN across all products.