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WTO notification · TBT

RussiaProposed measure, may since have been adopted

Pharmaceutical products – Russia

Official title

Draft amendments to the Rules of Good Manufacturing Practice in the Eurasian Economic Union

Russia notified this proposed TBT measure to the WTO on 17 November 2025. The comment period closed on 10 December 2025.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

Published here:

At a glance

Products

(Pharmaceuticals)

HS codes
  • 30 · Pharmaceutical products
    • 3003 Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl…
    • 3004 Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses 'incl. those for transdermal…
Notifying member
Russia(Russian Federation)
Status
Proposed measure, may since have been adoptedNotified as a draft on 17 November 2025. Check WTO ePing or Russia for its current status.
Objectives
  • Protection of human health or safety
  • Other
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/RUS/177
Keywords
Human health

Key dates

Distributed by the WTO
Comment deadline
Closed on 10 December 2025
Proposed adoption
To be determined
Proposed entry into force
To be determined

How to comment

The comment period closed on 10 December 2025. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/RUS/177; it can take them up with Russia.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

Supplementation of the Rules of Good Manufacturing Practice with Requirements for the production of high-tech medicines harmonized with the current version of the Rules of Good Manufacturing Practice of the European Union and relevant international standards to ensure stable quality of the production process of the specified group of drugs in order to promptly identify deviations in the production process, as a result of which the finished product will be recognized as substandard.

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

All updates from Russia

  1. WTO notificationSPSProposed measure, open for comments

    Draft Decision of the Collegium of the Eurasian Economic Commission on Amendments to Decision of the Customs Union Commission of 28 May 2010 No. 299

    The draft Decision amends Decision of the Customs Union Commission No. 299 of 28 May 2010 'On the Application of Sanitary Measures in the Customs Union': 1) It enables granting transitional periods for the entry into force of amendments to sanitary requirements subject to the following conditions…

    No products listed by the notifying member

    Symbol: G/SPS/N/RUS/362Comments until 30 November 2026

  2. WTO notificationSPSProposed measure, not in force yet

    1) Draft Decision of the Collegium of the Eurasian Economic Commission on Amendments to the Regulation on Common veterinary (sanitary and veterinary) requirements for goods…

    The draft decision amends the Common veterinary (sanitary and veterinary) requirements for goods subject to veterinary control (surveillance) in terms of the following matters: ­amendments of a legal and technical nature; ­addition of new terms and definitions used in the text; ­amendments to the…

    Symbol: G/SPS/N/RUS/361Comment period closed

  3. WTO notificationTBTProposed measure, not in force yet

    Draft Decision of the Council of the Eurasian Economic Commission amending certain decisions of the Council of the Eurasian Economic Commission

    The draft decision provides for the following: transition period extension until 31 December 2036 in order to prolong the period of circulation of diagnostic, disinfectant, disinfestation and deacarisational preparations for veterinary use in the territory of the Eurasian Economic Union (EAEU) in…

    Symbol: G/TBT/N/RUS/184Comment period closed

  4. WTO notificationTBTProposed measure, not in force yet

    Draft amendments to the Rules for registration and examination of safety, quality and effectiveness of medical devices

    The draft amendments to the Rules for registration and examination of safety, quality and effectiveness of medical devices provides for the possibility of suspending the validity of the marketing authorization in the event that there is no valid report on the results of inspection in the marketing…

    Symbol: G/TBT/N/RUS/183

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