Market Access services
in Estonia

Working with its clients to ensure a successful outcome in terms of market access, Grove consultants based in Estonia 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 ESTONIA – PRICING AND REIMBURSEMENT STRATEGY

Although relatively transparent, with the reimbursement list reviewed once every three months, it can still take a considerable length of time to get a product onto the local reimbursement list. This is a source of much frustration to many and underlines the importance of local insight for those attempting to navigate the pricing and reimbursement area in the country.

As in other areas, the State Agency of Medicines (SAM) and the Ministry of Health play a key role in the market for pharmaceuticals, medical devices, food supplements and cosmetics.

Only with an understanding of pricing and reimbursement policies in Estonia, can new market entrants hope to get their own reimbursement strategies and subsequent reimbursement submissions right. With experienced local consultants, Grove can assist with:

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

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

Beyond pricing and reimbursement, 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 – PHARMA COMPLIANCE AND PHARMA QUALITY ASSURANCE

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

Across key product areas of pharmaceuticals/medicines, medical devices 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 support in the Estonian market to meet EU serialization and NMVS (National Medicines Verification Systems) guidelines
  • Manufacturing, within which QA and good pharmaceutical manufacturing practice requirements must be met
  • 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 regulations and requirements
  • Data protection and GDPR
  • Packaging and labelling, to include tracking safety labelling changes and exemptions
Grove provides market access consultancy services across the following product areas:
  • Pharmaceuticals/medicines/drugs/medicinal products
  • Medical devices
  • Biologics
  • Cosmetics
  • Food and dietary supplements