Market Access services
in Montenegro

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 SERVICES IN MONTENEGRO – PRICING AND REIMBURSEMENT STRATEGY

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:

  • 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 MONTENEGRO – 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 guidelines
  • 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, well-connected local 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, 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, for example reporting supplies and sales of medicinal products to national authorities
  • Manufacturing, within which QA and good pharmaceutical manufacturing practice requirements must be met
  • RA consulting services to meet local distribution prerequisites, including QA and good distribution practice changes
  • Sales and marketing, providing appropriate RA support for local product launch and the review of promotional materials and patient support materials, for example
  • Sales and marketing, providing appropriate RA support for local product launch and the review of promotional materials and patient support materials, for example
  • Advertising; developing in complexity given changing market dynamics – a complex area
  • Data protection
  • Packaging and labelling, to include tracking safety labelling changes and issues associated with cross-border marketing in the Balkan region
Grove provides market access consultancy services across the following product areas:
  • Pharmaceuticals/medicines/drugs/medicinal products
  • Medical devices
  • Biologics
  • Cosmetics
  • Food and dietary supplements