Working with its clients to ensure a successful outcome in terms of market access, Grove consultants based in Serbia provide expert advice in three key areas:
Pricing and reimbursement policies remain extremely complex, less than transparent and a source of constant frustration for healthcare companies. As an accepted candidate for accession to the EU, the Serbian healthcare industry has been pushing hard for regulatory and best practice changes.
A positive shift in the mindset of the regulatory authorities is now evident and it is hoped that the introduction of initiatives such as the National Strategy on Medicines and managed entry agreements will help to drive the healthcare market forward as will the inevitable harmonization of regulation in line with EU requirements in the run up to the country becoming a full member of the EU.
As in other areas, the Medicines and Medical Devices Agency (ALIMS) and the Ministry of Health play a key role in the market for pharmaceuticals, medical devices, food supplements and cosmetics.
The highly bureaucratic, complex and still unpredictable local regulatory environment requires very careful navigation. Only with an understanding of the Serbian reimbursement policy, can new market entrants hope to get their own reimbursement strategies and subsequent reimbursement submissions right. With experienced local consultants, Grove can assist with: