Market Access services
in Croatia

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

The Croatian healthcare sector is relatively well developed and organized in comparison to its neighbours within the Balkan region. Regulatory systems are transparent and predictable.

The Croatian Institute for Health Insurance (CHIF) is the key regulatory authority involved in the reimbursement process in the country. The time taken for the approval for any reimbursement application is at best, six months, but in reality, the process can take up to a year.

The relatively transparent and predictable regulatory environment still requires careful navigation. Only with an understanding of the Croatian 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:

  • Understanding the local pharmaceutical reimbursement system
  • Understanding the Croatian reimbursement policy
  • 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 CROATIA – 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, well-connected locally based Grove consultants are ideally positioned to be able to provide regulatory affairs support to ensure client compliance in terms of relevant Croatian legislation and regulatory guidelines.

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, for example reporting supplies and sales of medicinal products to national authorities
  • RA support 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 pre-requisites and good distribution practice requirements within this
  • Sales and marketing, providing appropriate RA support for local product launch and the review of promotional materials and patient support materials, for example
  • Advertising, with specific regulations in force for the marketing of medicinal products, medical devices, traditional herbal medicinal products and homeopathic medicinal products
  • Data protection
  • Packaging and labelling, to include tracking safety labelling changes
Grove provides market access consultancy services across the following product areas:
  • Pharmaceuticals/medicines/drugs/medicinal products
  • Medical devices
  • Biologics
  • Cosmetics
  • Food and dietary supplements