Two legislative acts underpin the regulatory framework in Georgia: the Law on Drugs and Pharmaceutical Activities; and, the Law on the Licensing of Medical and Pharmaceutical Activities.

Although the legislation contained in the two main acts related to the local healthcare sector is comprehensive, the implementation of specific regulations is poorly managed, and the market is somewhat chaotic as a result. Polypragmasy is widespread; pharmacovigilance systems remain virtually non-existent in practice, and where prescription drugs are issued without prescription (a common practice) the associated fines (low in any event) are often not issued.

That said, it is a market with significant potential for the future and indeed, within a two-tier product registration system, product registration for products already authorized for use in the US, Canada and the EU, is a relatively simple and swift process. The introduction of the current registration process does not come without its problems however, and resultant increasing levels of competition within a somewhat unregulated market in terms of product safety are cause for concern.

As your local regulatory affairs partner Grove has access to the key institutions regulating the market, notably, the LEPL State Regulation Agency for Medical Activities.

Grove provides regulatory consulting services in the Georgian market in any one of a number of areas and can, if necessary, act as a full-service provider of regulatory services.