CIS & EAEU Pharma Regulatory Software | EAEU Decision 78, Russia & Uzbekistan RIM
Novaqis RIM unifies pharmaceutical registration and compliance across the Eurasian Economic Union (EAEU) and CIS territories. The platform streamlines EAEU Decision No. 78 unified dossier structuring, monitors mutual recognition and decentralized procedures across member states (Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan), tracks national-to-EAEU dossier transitions, and synchronizes Russian-language packaging proofing with Chestny ZNAK cryptographic DataMatrix serialization.
CIS / EAEU (Eurasia)
CIS / EAEU Compliance Mandate & Novaqis Solution
How Novaqis Regulatory Information Management (RIM) automates statutory compliance, dossier compilation, and packaging serialization for CIS & Eurasian Economic Union.
| Compliance Dimension | CIS / EAEU Statutory Mandate | Novaqis Automated Solution |
|---|---|---|
| EAEU Unified Dossier (Decision 78) | All drugs registered across Russia, Belarus, and Kazakhstan must align with EAEU Decision 78 electronic dossier standards, replacing legacy national registrations. | Automated EAEU XML dossier builder generating validated eCTD structures with country-specific Module 1 packages for reference and concerned member states. |
| Chestny ZNAK Cryptographic Serialization | Secondary packaging requires GS1 DataMatrix barcodes embedded with cryptographic verification keys (crypto-tail) issued by national CRPT tracking operators. | Artwork proofing and packaging verification verifying DataMatrix quiet zones, crypto-code footprint constraints, and readability on high-speed blister and carton lines. |
| Russian / Cyrillic Localization & SmPC | All clinical labeling, packaging cartons, and Package Inserts must be translated into Russian, with state-language requirements (Kazakh, Uzbek) for national markets. | Multi-lingual side-by-side text proofing engine verifying Cyrillic typography against approved SmPC terminology and detecting unapproved therapeutic phrasing. |
| EAEU Mutual Recognition Procedure (MRP) | Filing involves choosing a Reference Member State (RMS) followed by recognition in Concerned Member States (CMS) within strict statutory assessment windows. | Parent RMS-CMS procedural tracker mapping regulatory queries, response countdown clocks, and national approval certificates in one unified view. |
EAEU Unified Dossier (Decision 78)
All drugs registered across Russia, Belarus, and Kazakhstan must align with EAEU Decision 78 electronic dossier standards, replacing legacy national registrations.
Automated EAEU XML dossier builder generating validated eCTD structures with country-specific Module 1 packages for reference and concerned member states.
Chestny ZNAK Cryptographic Serialization
Secondary packaging requires GS1 DataMatrix barcodes embedded with cryptographic verification keys (crypto-tail) issued by national CRPT tracking operators.
Artwork proofing and packaging verification verifying DataMatrix quiet zones, crypto-code footprint constraints, and readability on high-speed blister and carton lines.
Russian / Cyrillic Localization & SmPC
All clinical labeling, packaging cartons, and Package Inserts must be translated into Russian, with state-language requirements (Kazakh, Uzbek) for national markets.
Multi-lingual side-by-side text proofing engine verifying Cyrillic typography against approved SmPC terminology and detecting unapproved therapeutic phrasing.
EAEU Mutual Recognition Procedure (MRP)
Filing involves choosing a Reference Member State (RMS) followed by recognition in Concerned Member States (CMS) within strict statutory assessment windows.
Parent RMS-CMS procedural tracker mapping regulatory queries, response countdown clocks, and national approval certificates in one unified view.
How Novaqis Overcomes EAEU Transition Bottlenecks
The mandated transition to unified EAEU dossiers has overwhelmed regulatory teams across CIS exporters. Novaqis provides the automated architecture to maintain continuous market supply.
National-to-EAEU Dossier Harmonization
Re-structure legacy Russian or CIS national dossier documents into compliant EAEU Decision 78 Modules 1–5 with complete version traceability.
RMS-to-CMS Variation Synchronizer
When a variation is approved by the Reference Member State (e.g., Kazakhstan), automatically trigger parallel variation notifications to all Concerned Member States.
Cryptographic Traceability Checkpoints
Verify packaging artwork compliance with Chestny ZNAK and Asl Belgisi (Uzbekistan) DataMatrix layout requirements.
CIS / EAEU Submission & Compliance Inquiries
Technical guidance on local submissions, dossier structuring, and packaging inspections.
How does Novaqis help with the mandatory transition to EAEU dossiers?↓
Can Novaqis manage non-EAEU CIS registrations like Uzbekistan and Azerbaijan?↓
Explore Neighboring Export Jurisdictions
Saudi Food and Drug Authority
Novaqis RIM provides end-to-end regulatory lifecycle management for pharmaceutical manufacturers and merchant exporters submitting to the Saudi Food and Drug Authority (SFDA). The platform automates Saudi eCTD Module 1 administrative workflows, monitors 5-year Marketing Authorization renewal deadlines with automated 180/90/30-day alerts, and bridges approved bilingual Arabic/English Package Inserts directly with RSD Tatmeen GS1 DataMatrix packaging serialization.
GCC & MENA Health Authorities
Novaqis RIM centralizes regulatory lifecycle operations across GCC and MENA health authorities, including UAE MOHAP, Egypt EDA, Jordan JFDA, and Oman MOH. The platform manages multi-country Marketing Authorizations, coordinates Gulf Health Council (GHC) centralized tenders, automates bilingual Arabic/English packaging variations, and tracks regulatory submissions across transitioning eCTD and NeeS formats.
Central Drugs Standard Control Organisation
Novaqis RIM provides end-to-end regulatory compliance and license lifecycle management for Indian pharmaceutical manufacturers, loan-license brand marketers, and merchant exporters interacting with the Central Drugs Standard Control Organisation (CDSCO) and State Licensing Authorities (SLAs). The platform tracks SUGAM portal filings, monitors Form 25/28 manufacturing and loan-license renewal cycles, manages Certificate of Pharmaceutical Product (COPP) renewals, and enforces CDSCO Revised Schedule M computerized data integrity controls out-of-the-box.
Ready to Automate Your CIS / EAEU Submissions?
Eliminate missed 5-year renewal deadlines, avoid packaging customs rejections, and coordinate external CDMOs under complete 21 CFR Part 11 audit trails.