№ files_lp_4_process_2_84053
WTO TBT notification describing proposed amendments to the Pharmacopoeia of the Eurasian Economic Union introducing new and revised general pharmacopoeial monographs for herbal and biological medicinal products aligned with Pharmacopoeial Discussion Group standards.
Notifying Member: Russian Federation
Agreement Framework: WTO Agreement on Technical Barriers to Trade (TBT)
Notification Article: Article 2.9.2
Responsible Agency: Russian Scientific and Technical Center for Information on Standardization, Metrology and Conformity Assessment (Standartinform)
Role of Agency: National enquiry point for the TBT Agreement
Products Covered (HS Codes): 3003; 3004
Product Category: Pharmaceuticals
Regulatory Area: Pharmacopoeia and medicinal product standards
Document Type: Draft amendments to regulatory decision
Related Authority: Board of the Eurasian Economic Commission
Referenced Decision: Decision No. 100 of 11 August 2020
Subject Matter: Amendments to the Pharmacopoeia of the Eurasian Economic Union including new and revised general pharmacopoeial monographs
International Harmonization Reference: Pharmacopoeial Discussion Group (PDG) texts
Objective: Protection of life and health of patients and protection of interests of healthcare institutions and medicinal product manufacturers
Number of Pages: 992
Language of Notified Draft: Russian
Comment Deadline: 7 December 2025
Proposed Date of Adoption: To be determined
Proposed Date of Entry into Force: To be determined
Access to Draft: https://regulation.eaeunion.org/orv/3264/
Price: 8 / 10 USD
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