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.
REGULATORY CONSULTING IN GEORGIA – PRE-SUBMISSION AND SUBMISSION ACTIVITIES
With their comprehensive understanding of local regulatory requirements, Grove’s regulatory affairs consultants work closely with their clients through the necessary pre-submission and submission activities required. Key within this is:
- Regulatory consulting – regulatory submissions and registration related services
- Preparation and submission of relevant documentation for drug registration and marketing authorization
- Liaison with local agencies to monitor progress
- Assistance with packaging/labelling approval (packaging material submissions, labelling compliance/approval)
- Readability testing for local language Patient Information Leaflets
REGULATORY AFFAIRS CONSULTING SERVICES IN GEORGIA – MAINTENANCE OF REGULATORY APPROVAL/MA
Grove’s in-country regulatory affairs team provides a full support service post-submission, and work with clients in the following areas:
- Post-marketing applications
- Marketing authorization transfer services
- Support for the management of national Agency databases
- Submission of annual specific national declarations
- Packaging/labelling compliance
REGULATORY AFFAIRS SERVICES IN GEORGIA – MONITORING OF LOCAL REGULATORY REQUIREMENTS
Completing the full-service regulatory package that Grove’s local regulatory affairs consulting team provide, Grove will:
- Monitor local regulatory change and provide appropriate updates
- Assess national regulatory documentation and provide appropriate updates
- Ensure compliance with local regulatory requirements given any change in national legislation, regulations and policies
- Provide relevant safety updates
Key product areas covered:
- Pharmaceuticals/medicines/drugs/medicinal products
- Medical devices
- Food and dietary supplements