Validity period
Maximum 10 years, or 15 years for low-risk products. Renewal for the same period is conditional on continued compliance (Law No. 34-18, Articles 29 and 34).
Regulatory lifecycle
Renewal requires an early review of the existing authorization, changes since approval and evidence that may need updating before the applicable deadline.

Maximum 10 years, or 15 years for low-risk products. Renewal for the same period is conditional on continued compliance (Law No. 34-18, Articles 29 and 34).
Submit the marketing authorization renewal application to ONSSA at least two years before expiry (Decree No. 2-22-855, Article 34).
Late applications are rejected (Article 34). Under Article 37, eligible stocks imported or manufactured before expiry may be sold for up to 12 months and used for up to 24 months. These allowances do not apply to withdrawals for health or environmental reasons (Article 36).
Sources: Law No. 34-18 · Decree No. 2-22-855
Review of certificate, uses, label, sources, specifications and previous commitments.
Identification of new evidence, conclusions or requirements that may affect the product or active substance.
Assessment of manufacturer, source, composition, rate, use, PHI, packaging or ownership changes.
Backward planning and preparation of a consolidated, quality-controlled renewal package.
Working method
Each stage produces a clear output and a documented decision point.
Before any submission, we check the applicable texts, the authority’s procedure and the evidence required for your project.
Related expertise