Georgia Registration Renewal: 5-Year Certificates and Re-Registration

1. Key takeaways

Registration certificates in Georgia are valid for 5 years, according to the practical estimate. The legal source is Article 11⁵ paragraph 1 of the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009, under which the validity of a marketing authorisation is determined under the recognition regime and the national regime. A renewal (re-registration) application must be submitted at least 2 months before expiry, the procedure takes approximately 1 to 3 months, and — again as a practical estimate — renewal applies only to certificates registered under the national regime.

The final point deserves particular attention in pathway selection. If certificates issued through the recognition regime cannot be renewed and instead require a fresh application, then the true cost of the recognition route includes a complete second procedure after 5 years. Comparing pathways on the first cycle alone understates the lifetime cost of recognition, and manufacturers should price the second 5-year period into the original route decision rather than discovering it at expiry.

Back-scheduling is the operative discipline of renewal work. Because the 2-month submission window and the 1-to-3-month processing time are practice values rather than statutory terms, the only dates that are certain are the certificate’s own expiry and the dates the manufacturer creates internally. A renewal plan anchored to the certificate date — with evidence reuse, internal review, and submission assigned to fixed offsets — removes the dependency on any externally promised turnaround and keeps the renewal independent of third-party schedules.

2. Legal basis

The renewal framework rests on the following provisions.

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 11⁵ paragraph 1 (the validity of a marketing authorisation is determined under the recognition regime and the national regime).
2. Article 11¹¹: national registration under the national regime, including re-registration.
3. Article 11⁷: national registration under the recognition regime, covering validity of registration, suspension and revocation.
4. Article 11⁶: entry in the sectoral registry and maintenance of registry information.
5. Article 11¹⁰ paragraph 6: the agency may revoke the registration and remove the entry from the sectoral registry.
6. Practical estimate statement: the 5-year validity, the 2-month advance submission, the 1-to-3-month timeline, and the restriction of renewal to the national regime are not stated in any official legal text and derive from established industry practice.

The renewal provisions interact with the registry provisions of Article 11⁶: a renewed certificate is only as useful as the registry entry behind it, and the reconciliation of names, addresses, and models during the renewal window is what keeps the two consistent at the moment the new certificate issues.

3. Expert insights

Insight 1: the practice that renewal applies only under the national regime exposes a lifecycle difference between the regimes. If a certificate obtained through the recognition regime cannot be renewed and must instead be re-applied for, products registered through recognition face a complete procedure again after 5 years. Route selection should therefore include the cost of the second 5-year period from the outset, not only the first cycle. For a long-lived portfolio, the lifetime cost difference between the regimes can exceed the first-cycle difference that usually drives the decision.

Insight 2: Article 11⁵ paragraph 1 delegates validity to the regimes rather than fixing a uniform number. The statutory wording suggests that validity may vary by regime and by product category. Manufacturers should not default to 5 years in planning systems; the validity recorded on the certificate is the controlling value, and the renewal plan should be back-scheduled from the certificate date. Certificate data should be entered into the expiry ledger directly from the issued document, never from the application assumptions.

Insight 3: renewal is not automatic, and missing the deadline is equivalent to a fresh application. The revocation and removal mechanism of Article 11¹⁰ paragraph 6 shows that registration status is something that can be maintained but also lost. When a certificate lapses without renewal, the product’s registry status is no longer valid, and sales and customs clearance are blocked simultaneously. The expiry ledger and the back-scheduled renewal plan are the only reliable defence against this cliff-edge failure mode.

4. Practical recommendations

The following measures convert renewal from a deadline risk into a routine process that runs on the calendar rather than on alerts.

1. Maintain a certificate expiry ledger back-scheduled from the dates recorded on the certificates: start evidence reuse at 6 months before expiry and submit the renewal at least 2 months before expiry.
2. Flag recognition-regime certificates separately in the ledger and budget and schedule them as fresh applications rather than renewals, reflecting the practical estimate that renewal applies only to the national regime.
3. Reuse the first-registration dossier for the renewal file and update only the changed items and the latest evidence; a full rewrite adds cost without adding review value.
4. During the renewal period, reconcile the registry information in parallel, confirming that names, addresses, and models match the current situation before the renewed certificate issues.
5. Record the renewal outcome and the new certificate date in the ledger immediately upon issuance, so the next back-schedule starts from a verified date rather than an assumption.

The renewal project is also the natural checkpoint for portfolio housekeeping: models that have been discontinued should be allowed to lapse deliberately, models whose evidence has been superseded should be refreshed, and the comparison tables of recognition-regime certificates should be re-validated against the current reference approvals. Spreading this housekeeping across the year, one certificate at a time, prevents it from accumulating into a renewal-season bottleneck.

5. Verification checklist

• □ Certificate expiry ledger established and back-scheduled from certificate dates
• □ Evidence reuse started 6 months before expiry
• □ Recognition-regime certificates scheduled as fresh applications
• □ Renewal dossier updates only changed items and latest evidence
• □ Registry information reconciled during the renewal period

Regulatory information verified as of October 30, 2026

This English version was prepared by GRZAN for the international medical device registration guide. GRZAN provides regulatory translation, dossier preparation and market-entry support for Georgia and other jurisdictions. Questions about this article may be sent to info@grzanglobal.com.