Georgia Recognition Regime: Same-Product Evidence under Article 11-7

1. Key takeaways

Whether the recognition regime works in a given case depends on one document: the same-product identification evidence that demonstrates the product filed in Georgia is identical to the product approved in a reference country. The legal anchor is Article 11⁷ of the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009. The same article also governs the validity of registration obtained through recognition, as well as its suspension and revocation. This tells applicants something important: recognition is a complete channel with its own exit mechanisms, not a temporary convenience or an informal courtesy extended at the discretion of the authority.

Because the recognition regime stands on the strength of the reference approval, its durability is borrowed rather than owned. If the reference-country approval is later revoked, suspended, or allowed to expire, the Georgian registration that rests upon it loses its foundation and becomes exposed to the verification and revocation machinery of Article 11¹⁰. Manufacturers should therefore treat the reference approval as a living asset that must be monitored for its entire life, not as a snapshot presented once at filing and then forgotten.

The dependency also shapes documentation discipline. Since the Georgian registration stands on the reference approval, the dossier should be maintained as a living file: the comparison table, the reference certificate copies, and the status-monitoring record belong together in one place, so that any change in the reference country can be assessed and reported without reconstructing the file from correspondence archives. Teams that store the sameness evidence with the original filing paperwork and never revisit it discover, at renewal or at verification, that the evidence no longer reflects the reference approval as it currently stands.

2. Legal basis

The following provisions define the recognition channel and its boundaries.

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009: Article 11⁷ — national registration under the recognition regime.
2. Article 11¹⁰ (Article 1110): verification of the same-product identification documents; paragraph 6 empowers the agency to revoke the registration and remove the entry from the sectoral registry.
3. Article 11⁶ paragraph 4: entry in the sectoral registry under the recognition regime, either upon application or after administrative review.
4. Article 11⁵ paragraph 1: the validity of a marketing authorisation is determined under the two regimes.
5. Law of Georgia No. 6157-Iს on Product Safety and Free Movement of May 8, 2012, Article 3 paragraph 1: products of listed states may be placed on the market without restriction; Article 2 paragraph 3: products manufactured in conformity with the new approach and global approach directives of the European Union satisfy the essential safety requirements of the code.
6. Practical estimate statement: the scope of the reference-country list, the accepted forms of evidence, and the review timeline are not stated in any official legal text and must be confirmed with the authority case by case.

3. Expert insights

Insight 1: Article 11¹⁰ makes verification a standalone step, which proves recognition is not a formality. The legislator devoted a separate article to the verification of same-product identification documents, and paragraph 6 of that article allows the registration to be revoked when verification fails. The convenience of recognition is therefore built on the authenticity of the evidence. Once the status of the reference approval changes — revoked, suspended, or expired — the Georgian recognition basis moves with it. This is why the recognition regime must be administered as a monitored dependency, with the reference certificate tracked across its entire validity.

Insight 2: entry under the recognition regime has two possible forms — upon application and after administrative review. The wording of Article 11⁶ paragraph 4 preserves space for registry entry without a full administrative review. Applicants may argue for the direct form of entry, but the argument is credible only when the sameness evidence is complete and internally consistent. A file with unresolved comparison gaps pushes the authority toward the reviewed form of entry, which erodes most of the time advantage that recognition was supposed to deliver.

Insight 3: the recognition regime shares the validity rules written for both regimes, so the Georgian validity is not automatically the reference validity. Article 11⁵ paragraph 1 delegates the determination of validity to the two regimes rather than fixing a uniform number. The practical conclusion is that the Georgian validity must be confirmed on its own terms and cannot be assumed to mirror the term of the reference certificate. Teams that copy the reference expiry date into their planning sheets create a silent compliance risk that surfaces exactly when the certificate is needed for customs or tender documents.

4. Practical recommendations

The following measures keep a recognition file defensible from filing through the whole life of the certificate.

1. Build a sameness comparison table and reconcile it field by field: product name, models, manufacturer name and address, manufacturing site, specifications and parameters, and intended use. Every reconciled field should carry an evidence pointer to the reference approval or the Georgian file.
2. Provide the reference-country approval documents as originals or notarised copies, and confirm they are within their validity at filing. Start the renewal of the reference approval at least 3 months before its expiry, and synchronise any resulting changes into the Georgian dossier.
3. State on the first page of the dossier the conclusion that the product is the same product approved in the reference country, together with the basis for that conclusion, so the reviewer can locate the core argument immediately instead of assembling it from scattered sections.
4. When the status of the reference approval changes in any way, notify the Georgian regulatory agency proactively. A self-reported change is a maintenance action; a change discovered during verification becomes grounds for revocation under Article 11¹⁰ paragraph 6.

5. Verification checklist

• □ Sameness comparison table covers all key fields
• □ Reference approval documents are originals or notarised copies and within validity
• □ Sameness conclusion stated on the first page of the dossier
• □ Georgian validity confirmed rather than assumed equal to the reference term
• □ Notification mechanism for reference-approval status changes established

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.