The Estonian State Agency of Medicines (SAM) has worked hard to improve transparency and ease of access for new entrants to the Estonian healthcare market. Electronic data exchange is widespread and harmonization with EU legislation increasingly common. The small size of both the market and the regulatory authorities involved aids the speed of implementation of any regulatory change.

That said, the reimbursement process in particular remains slow and complex and there are local pharmacovigilance requirements that must be met over and above those dictated by EU legislation. Understanding the regulatory affairs and local pharmacovigilance processes is vital if new market entrants are to optimize their pricing and reimbursement submissions in the country and develop an appropriate pharmacovigilance response. Access to a local regulatory partner and to local pharmacovigilance services is an essential pre-requisite to executing successful market entry and development.

Grove is a specialist CEE focused healthcare consulting firm and its expertise in Estonia spans four key areas:

• regulatory affairs consulting (including regulatory intelligence)
• pharmacovigilance services
• market access, including pricing and reimbursement applications
• market assessment, including intelligence on medical device regulations,
• opportunity evaluation and regulatory risk assessment

GROVE AS YOUR PARTNER IN ESTONIA FOR REGULATORY AFFAIRS, PHARMACOVIGILANCE AND MARKET ACCESS

For over twenty years Grove has successfully provided regulatory, PV and market access services to a wide range of clients to help them navigate the specifics of the Estonian market. With experienced locally based consultants, clients gain access to an unrivalled depth of local knowledge and understanding in all areas associated with entering and operating in the country.

Regulatory affairs, pharmacovigilance, market access and pharmaceutical consulting services are all key areas of Grove expertise.