Expertise

Medicinal Products & Lifecycle

Registration, APIs, dossier alignment and lifecycle changes

Medicinal Products & Lifecycle

Medicinal product registration and lifecycle management are the core of the Pharegis regulatory practice. This section brings together three connected workstreams: EAEU medicinal product registration, registration of active pharmaceutical ingredients in Russia, and post-approval variations.

Core workstreams

EAEU medicinal product registration. Regulatory pathway selection, dossier alignment, authority submission and maintenance of the marketing authorisation.

API registration in Russia. Drug-substance and CMC documentation, submission support and ongoing regulatory compliance.

Variations & lifecycle. Change assessment, classification, dossier preparation and implementation under EAEU and applicable national procedures.

Detailed guidance on each workstream is available below.

EAEU · Registration

Drug Registration in Russia under EAEU Rules: Dossier Strategy, Quality Expertise and Market Authorization

Drug registration in Russia under EAEU rules: pathway selection, CTD dossier, CMC, 3.2.P.5, GMP, samples, evidence, expert review and lifecycle strategy.

 EAEU · Dossier alignment

EAEU Dossier Alignment after 31 December 2025: Transitional Cases and Portfolio Decisions

Post-2025 EAEU dossier alignment: pending transition cases, extended national authorizations, recognition states, dossier reconciliation, CMC, GMP and lifecycle strategy.

 Russia · API / CMC

Registration of Active Pharmaceutical Ingredients (API) in Russia

API registration in Russia for commercial active pharmaceutical ingredients: CMC review, GMP, ND, samples, standards, lab testing and lifecycle support.

 EAEU · Variations

EAEU Variations Management: Classification, Grouping and Lifecycle Control

EAEU medicinal-product variations under Decision 78 Appendix 19: IA, IA_NU, IB, II, extensions, grouping, recognition-state strategy and Russia-specific API changes.

 EAEU · CMC / Pharmacopoeia

EAEU Quality Document and Pharmacopoeial Alignment: Turning the Global CMC Dossier into a Usable Regulatory Standard

EAEU Quality Document strategy: align the global CMC dossier, pharmacopoeial framework, expert laboratory assessment and lifecycle without unnecessary local technical complexity.

 EAEU · Product information

EAEU SmPC, Patient Leaflet and Labeling: Harmonizing Product Information Across Member States

EAEU SmPC, patient leaflet and labeling: Decision 88/18, generic reference-product updates, 120-day lifecycle control, translation, variations and multi-state implementation.