Market Access services
in Georgia

Working with its clients to ensure a successful outcome in terms of market access, Grove local consultants provide expert advice in three key areas:

  • Pricing and reimbursement
  • Regulatory affairs (RA) support for local product launch, sales and marketing
  • Pharma compliance
  • Pharma quality assurance

PHARMA MARKET ACCESS GEORGIA – PRICING AND REIMBURSEMENT STRATEGY

At present there is no state involvement in pricing within the Georgian healthcare market. Reimbursement policies are limited and difficult to navigate without on-the-ground local experience and insight.

Despite the introduction of the Universal Healthcare Program (UHC) in 2013, designed to address high private healthcare costs, concerns remain with regard to continued high levels of patient out-of-pocket payment for medicines in the country. This has led the regulatory authorities to consider pricing and reimbursement as increasingly important issues within the regulatory mix.

As in other areas, LEPL State Regulation Agency for Medical Activities plays a key role in the market for pharmaceuticals, medical devices, food supplements and cosmetics.

Despite positive regulatory change in the area of product registration (which has had a knock-on effect on pricing and availability of medicines in the Georgian market), the Georgian healthcare market is chaotic and difficult to work with. And it continues to change, rapidly. Given this, there is a real need for new market entrants to thoroughly understand local reimbursement policies, in the context of market pricing. Only with an understanding of current and future expected pricing and reimbursement policy, can new market entrants hope to get their own price and reimbursement strategies and subsequent reimbursement application right. With experienced local consultants, Grove can assist with:

  • Understanding the local pharmaceutical reimbursement system
  • Understanding pricing regulations
  • The development of appropriate pricing strategies
  • Access to key opinion leaders and healthcare decision makers
  • Translation of all related documentation
  • Reimbursement applications
  • Reimbursement status monitoring and maintenance
  • Timely follow up and communication with experts
  • Administrative support at all levels

MARKET ACCESS GEORGIA – REGULATORY AFFAIRS SUPPORT FOR LOCAL PRODUCT LAUNCH, SALES AND MARKETING

Locally based consultants provide expert regulatory affairs support for local product launch, sales and marketing. This includes:
  • Review of advertising, promotional and educational materials to meet local regulatory requirements
  • Validation and submission of relevant materials to appropriate local agencies
  • Provision of local management support required/relevant local databases
  • Facilitation of direct communication with local healthcare professionals

MARKET ACCESS GEORGIA – PHARMA COMPLIANCE AND PHARMA QUALITY ASSURANCE

Experienced, well-connected local Grove consultants are ideally positioned to be able to provide regulatory affairs support to ensure client compliance in terms of relevant Georgian legislation and regulatory requirements.

Across key product areas of pharmaceuticals/medicines and biologics, food and dietary supplements and cosmetics, areas in which Grove consultants provide regular input to ensure client compliance include:
  • Local notifications and authorization support
  • RA consulting services to meet local manufacturing guidelines
  • RA consulting services to meet local distribution prerequisites
  • Sales and marketing, providing appropriate RA support for local product launch and the review of promotional materials and patient support materials, for example
  • Advertising, to ensure local requirements are fully understood and adhered to
  • Data protection
  • Packaging and labelling
Grove provides market access consultancy services across the following product areas:
  • Pharmaceuticals/medicines/drugs/medicinal products
  • Medical devices
  • Biologics
  • Cosmetics
  • Food and dietary supplements