Construction permits and approvals in Georgia in the pharmaceuticals sector: what changed in 2027

Foreign pharmaceutical companies planning to build or expand manufacturing and storage facilities in Georgia face a materially different approval landscape in 2027. Changes to the construction permit framework applicable to the pharmaceuticals sector introduced new pre-permit requirements, expanded the role of the Georgian Medicines and Pharmacy Regulatory Agency, and created mandatory coordination steps with the Ministry of Economy and Sustainable Development before a construction permit can issue. For foreign investors — whether structuring a greenfield manufacturing site, an API warehouse, or a logistics facility tied to pharmaceutical distribution — understanding what changed and in what sequence the approvals now run is the threshold question.

Georgia's general construction permitting framework has long been governed by the Law on Construction Activity (as periodically revised) and administered through the relevant municipal and national bodies depending on project scale. Until recently, pharmaceutical-use facilities were treated, for construction permit purposes, largely in the same category as general industrial premises, with sector-specific regulatory requirements — GMP compliance, medicines agency registration — running on a parallel track that commenced after the construction permit was obtained.

The shift that took effect in early 2027 introduced a dependency between the two tracks. Under the revised framework, applicants for construction permits in respect of facilities intended for pharmaceutical manufacturing, secondary packaging, or regulated pharmaceutical storage are now required to obtain a preliminary sector consent from the Medicines and Pharmacy Regulatory Agency (MEPA) before the municipal or national permitting authority will accept a complete application. This preliminary consent does not authorise construction; it confirms that the proposed facility, as described in the submitted design documentation, is capable in principle of meeting the applicable GMP and pharmaceutical storage standards. Only once that preliminary MEPA confirmation is in hand does the standard construction permit procedure continue.

In practice, this means the approval pathway for a pharmaceutical facility now has a sequenced two-stage structure at the front end — a sector pre-clearance followed by the construction permit itself — rather than the parallel or post-construction licensing approach that characterised earlier practice.

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The revised framework applies to any entity applying for a construction permit in Georgia in connection with premises that will be used for a regulated pharmaceutical purpose. This covers:

• greenfield pharmaceutical manufacturing facilities, including API production sites
• secondary packaging and labelling facilities where the packaging process is regulated under Georgian pharmaceutical law
• temperature-controlled pharmaceutical storage and distribution hubs intended to hold medicinal products requiring GMP-standard conditions
• facilities constructed as part of a joint venture or contract manufacturing arrangement where the Georgian entity holds or intends to hold a pharmaceutical licence

The changes are most immediately relevant to foreign-owned entities: subsidiaries of European, Russian, Asian, or US pharmaceutical manufacturers entering or expanding in the Georgian market, and to investors using Georgia as a re-export or regional distribution hub given its position on trade routes between the EU, Turkey, and the CIS region.

The materiality of the change for foreign investors lies not only in the added approval step but in its timing implications. MEPA preliminary review involves substantive assessment of design documentation against pharmaceutical standards. That assessment is not instantaneous. Investors who have prepared project timelines on the assumption that sector licensing begins after construction is complete will need to revise their development programmes and, depending on contractual commitments already made, may face delay exposure.

"The 2027 revision effectively requires pharmaceutical investors to engage a regulatory dialogue with MEPA at the design stage — before the contractor relationship is confirmed and before the building permit clock starts. Investors used to sequential post-construction licensing models will find this front-loading of regulatory review both unfamiliar and timeline-critical." — Nino Beridze, Contributing Regional Analyst — Georgia, Vetrov & Partners

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For foreign investors at the planning stage, the practical priority is to restructure the project timeline to front-load the MEPA preliminary consent phase. This means:

• Preparing or commissioning design documentation at a level of detail sufficient for MEPA preliminary review before the construction permit application is filed. The documentation requirement for preliminary MEPA consent includes, at minimum, a conceptual facility layout, a description of the pharmaceutical processes to be conducted, and a summary of the proposed quality assurance and environmental control systems.

• Engaging Georgian regulatory counsel at the design stage — not at the permitting stage. The assessment MEPA conducts against the design is substantive, and design modifications requested after preliminary review can significantly affect both construction costs and programme schedules. Counsel familiar with Georgian pharmaceutical regulation can identify design issues before they enter the MEPA review process.

• Confirming whether the facility triggers any additional consent requirements at the intersection of construction and pharmaceutical regulation — for example, where a facility involves hazardous materials storage, controlled substances, or lies within a designated development zone that has its own planning overlay.

• Verifying the applicable permitting authority. Georgia's construction permitting landscape distinguishes between permits issued at the national level (Ministry of Economy and Sustainable Development for projects above defined thresholds) and permits issued at the municipal level. Pharmaceutical facilities of significant scale will typically engage national-level permitting, which has its own procedural timeline distinct from municipal approval.

For investors who are already partway through a development programme — with design completed or a building permit application in preparation — the immediate step is to assess whether the MEPA pre-clearance requirement applies to the facility as designed and, if so, to initiate that process without further delay. The standard construction permit procedure does not pause; MEPA preliminary review runs as a separate track that must be completed before the permit application will be accepted as complete.

It is worth noting that the revised framework does not affect construction already underway under permits issued before the 2027 amendments took effect. Projects with valid pre-2027 construction permits continue under the terms of those permits for the currently authorised scope.

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Q: What specifically changed in the Georgian pharmaceutical construction permit framework in 2027?

A: The central change is the introduction of a mandatory preliminary consent from the Medicines and Pharmacy Regulatory Agency (MEPA) as a precondition for filing a complete construction permit application in respect of pharmaceutical-use facilities. Previously, sector-specific pharmaceutical licensing and general construction permitting ran on largely independent tracks, with pharmaceutical regulatory engagement typically beginning after construction was complete. Under the revised framework, MEPA reviews the design documentation for compliance in principle with GMP and pharmaceutical storage standards before the permit application is accepted. This preliminary consent is not itself a construction authorisation; it is a pre-permit sector clearance that unlocks the main permit procedure.

Q: Which foreign companies are affected by the 2027 changes to Georgia's pharma facility approvals?

A: The revised framework applies to any entity — domestic or foreign-owned — applying for a construction permit for premises intended for pharmaceutical manufacturing, secondary packaging, or regulated pharmaceutical storage. Foreign-owned subsidiaries, joint ventures, and contract manufacturing arrangements where the Georgian entity holds or will hold a pharmaceutical licence all fall within scope. The most immediate practical effect is on foreign investors who have planned project timelines on the assumption that pharmaceutical regulatory engagement begins after construction: those timelines will need revision. Investors using Georgia as a regional distribution hub should also verify whether their storage facility specifications bring them within the regulated pharmaceutical storage definition.

Q: What should a foreign investor do if they have already committed to a pharmaceutical construction project in Georgia?

A: The first step is to confirm whether the construction permit was issued before the 2027 amendments took effect. Projects already under construction under a valid pre-2027 permit are not required to obtain MEPA preliminary consent retrospectively for the currently authorised scope. For projects at the application stage — design complete, permit application not yet filed or not yet accepted as complete — the MEPA preliminary consent process must be initiated before the permit application will be processed. Engaging Georgian regulatory counsel at this point to assess the design documentation against MEPA's preliminary review criteria, and to manage the MEPA consent application in parallel with final permit preparation, is the most effective way to minimise programme delay.

Vetrov & Partners is a boutique law firm established in 2009, recognised by Pravo-300 for eight consecutive years and listed as a trusted adviser by the German Consulate General in Novosibirsk. The firm advises foreign companies on regulatory and licensing matters across Russia and, in collaboration with regional counsel, across Georgia and neighbouring jurisdictions.

The firm's regulatory and licensing practice advises foreign investors — including pharmaceutical manufacturers, distribution companies, and sector investors — on approval frameworks, licensing sequences, and the intersection of construction and sector regulation in Georgia and the wider region. Matters are handled with direct partner involvement throughout.

We are a Russian-qualified law firm. For matters governed by Georgian law or requiring local admission in Georgia, we collaborate with trusted counsel in the relevant jurisdiction.

Enquiries: info@vetrovpartners.com | WhatsApp / Telegram: +7 (983) 510-38-76 | t.me/vitvetcom

This publication is provided for informational purposes only and does not constitute legal advice under Russian or any other applicable law. The information herein should not be relied upon as a substitute for professional legal counsel tailored to your specific circumstances. Vetrov & Partners is a Russian-qualified law firm. For matters governed by foreign law or requiring local admission in another jurisdiction, we collaborate with trusted counsel in the relevant jurisdiction. For advice regarding your particular situation, please contact info@vetrovpartners.com.

— Nino Beridze Contributing Regional Analyst — Georgia, Vetrov & Partners vetrovpartners.com/contributions/