Georgia National Registration Regime: Two-Stage Review under Article 11-11

1. Key takeaways

The national regime is the most complete registration route in Georgia. Its structure is a two-stage sequence of administrative review followed by scientific-technical review, established by Article 11¹¹ of the Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009. The same article also governs re-registration, Type I and Type II variations, validity of registration, documentation requirements, registration fees, suspension and revocation. Among the provisions of the Georgian registration framework, Article 11¹¹ carries the highest density of procedural content, which makes it the single article every national-route project must be mapped against from day one.

For project planning, the two-stage structure is not a formality — it is a risk-management tool. Administrative deficiencies can be isolated and corrected before the scientific-technical review begins, provided the dossier is physically and logically separated into the two stages. A manufacturer who files one undivided stack of documents gives up this protection and exposes the whole file to being returned mid-review for defects that a separated filing would have caught in the first stage.

The national regime is also the regime under which re-registration and variations operate, which means every lifecycle event after the first certificate — renewal, Type I and Type II changes, registry updates — is processed through the machinery of Article 11¹¹. A manufacturer who invests in a well-structured first filing therefore builds infrastructure for the whole certificate life: the two-volume architecture, the formality checklist, and the fee workflow created for the first registration are reused at every subsequent filing. Treating the first national registration as a one-off project forfeits this compounding advantage.

2. Legal basis

The national regime is defined by the following provisions.

1. Law of Georgia on Drugs and Pharmaceutical Activity, Law No. 1586 of August 10, 2009, consolidated version of November 30, 2023: Article 11¹¹ (Article 1111) — national registration under the national regime.
2. Matters covered by the same article: registration application, administrative review, scientific-technical review, re-registration, Type I and Type II variations, validity of registration, registration documentation requirements, registration fees, suspension and revocation of registration.
3. Article 11⁶ paragraph 5: entry in the sectoral registry upon completion of the Article 11¹¹ procedure.
4. Article 11⁵ paragraph 1: the validity of a marketing authorisation is determined under the two regimes.
5. Article 12 paragraph 2: manufacture of unregistered products is permitted for registration purposes, for preclinical and clinical trials, and for export.
6. Article 4¹ (Article 41): data confidentiality and exclusivity.

Read together, these provisions show that the national regime is self-contained: it defines its own review stages, its own fee requirement, and its own exit conditions, while Article 11⁶ supplies the registry endpoint and Article 11⁵ supplies the validity frame. Only Article 12 paragraph 2 reaches outside the registration chapter, authorising the sample production on which the review itself depends.

3. Expert insights

Insight 1: the value of the two-stage structure is that correction risk can be segmented. Administrative review answers whether the file is complete; scientific-technical review answers whether the product is acceptable. When the dossier is bound and paginated in two separate volumes, gaps found at the administrative stage are corrected before the technical stage starts, avoiding a situation in which the entire file is returned mid-review because of an administrative blemish. This segmentation is costless at filing time and expensive to retrofit after an objection, so it should be built into the dossier architecture from the first draft.

Insight 2: Article 11¹¹ writes registration fees into the statutory text, which makes payment a procedural requirement. The fee provision sits alongside the documentation requirements, meaning the payment receipt functions as one of the formal elements of an acceptable application. Project schedules should therefore place the payment and invoicing workflow on the critical path rather than treating it as a financial tail task. A file that is substantively ready but unpaid is, from the reviewer’s perspective, not ready at all. For multi-market teams, this also means the Georgian payment step must be built into the global launch plan with the same weight as the dossier milestones themselves.

Insight 3: Article 12 paragraph 2 opens a lawful channel for samples and pilot production. The provision permits the manufacture of unregistered products for registration purposes, resolving the circular problem in which registration requires samples but manufacturing an unregistered product would otherwise be unlawful. Manufacturers preparing registration samples therefore have an explicit legal basis and do not need to interrupt sample production while the certificate is pending. Documenting this basis in the internal quality system keeps the sample lot traceable and defensible.

4. Practical recommendations

The following practices align a national-regime project with the structure of Article 11¹¹.

1. Bind the dossier in two volumes — an administrative volume and a technical volume — and number each volume independently, so corrections in one stage never disturb the pagination of the other.
2. Run one formality self-check on the administrative volume before submission: application form, letter of authorisation, payment receipt, and notarised translations must all be present and consistent before the file leaves the building.
3. Organise the technical volume according to the logic of scientific review: product description, intended use, risk analysis, performance and clinical evidence, and conclusions, in that order, with cross-references that a reviewer can follow without assistance.
4. Use Article 12 paragraph 2 to start sample production early, running sample preparation in parallel with dossier preparation instead of waiting for the review to request samples.
5. Keep a project log of every correction made during administrative review, because the log becomes the template for the formality self-check of the next filing and steadily reduces correction cycles.

5. Verification checklist

• □ Dossier bound in separate administrative and technical volumes
• □ All four formality elements of the administrative volume present
• □ Technical volume arranged in the sequence of scientific review and paginated
• □ Registration fee payment receipt included in the submission package
• □ Lawfulness of sample production documented under Article 12 paragraph 2

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.