Quality standards in Georgian healthcare since 1992

Since 1992, Mermisi has worked in Georgian healthcare with one purpose: making sure patients here can get the medicines their clinicians prescribe. The market has changed considerably in that time. Our approach to selecting what we distribute has not.

As Georgia's regulations have tightened, we have kept quality as a documented, verifiable standard rather than a claim. What follows is how we assess a manufacturer before a product enters our portfolio.

How we assess manufacturers

We do not rely on a manufacturer's own assurances. For each product we review the manufacturing status of both the active pharmaceutical ingredient (API) and the finished dosage form (FDF), and we ask for the underlying certificates.

The certifications below are held by the manufacturers we work with, issued by the authorities named. They are the manufacturers' certifications, not Mermisi's, and we verify them before and during a supply relationship.

• EU GMP or US FDA-recognised manufacturing status — issued by a European Union competent authority or, in the case of the United States, established through FDA inspection. Note that establishment registration with the FDA is a filing obligation and is not the same as approval or inspection.
• PIC/S participating authority GMP — a GMP certificate issued by an authority that participates in the Pharmaceutical Inspection Co-operation Scheme, which supports comparable inspection standards across member countries.
• European Pharmacopoeia monographs — products selected against Ph. Eur. monograph requirements, with Certificates of Suitability issued by the EDQM held by the relevant manufacturers where applicable.

Where a certificate has expired or its scope does not cover the product in question, the product does not enter our portfolio.

What the new regulations changed

Georgia's regulatory requirements have become more demanding, particularly around recognised GMP evidence across the supply chain. For manufacturers already holding EU, PIC/S or FDA-recognised status, this generally simplifies market entry rather than complicating it, because the evidence required is documentation they already hold.

We continue to look for manufacturers with verifiable GMP status, documented supply chain integrity, and the ability to support a product through registration, pharmacovigilance and long-term supply.

Access: affordability and reach

A medicine that is registered but unavailable helps nobody. Two things determine whether it reaches a patient:

1. Affordability — supply terms and reimbursement pathways determine what a patient actually pays. We prepare and submit reimbursement dossiers to national and municipal payers as part of bringing a product to market.
2. Geographic reach — we supply hospitals and clinics nationwide and operate specialist pharmacies located adjacent to major cancer centres, so that patients outside Tbilisi are not dependent on travelling for supply.

Since 1992

Over three decades in this market has taught us that the useful question is not whether a company says it works to international standards, but whether it can show you the certificates, the procedures and the inspection history behind that claim. We are glad to do so for any prospective partner.

This article is general information about medicine supply and regulation in Georgia. It is not promotional material for any medicine and is not intended as medical advice.