Working with its clients to ensure a successful outcome in terms of market access, Grove local consultants provide expert advice in three key areas:
The healthcare sector is Montenegro is small but with EU accession a key government objective, there is considerable work in process to harmonize the regulatory environment in line with EU legislation. The regulatory system however, lacks transparency at all levels and there is a continued lack of transparency and predictability in both pricing and reimbursement policies.
As in other areas, the Agency for Medicines and Medical Devices (CALIMS) and the Ministry of Health play a key role in the market for medicines, medical devices, food supplements and cosmetics.
The still embryonic regulatory framework requires exceptionally careful navigation. Only with an understanding of the local 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: