Market Access services
in Poland

Working with its clients to ensure a successful outcome in terms of market access, Grove consultants based in Poland 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 POLAND – PRICING & REIMBURSEMENT STRATEGY

The Polish healthcare sector is relatively well developed and organized in comparison to others within the Central and Eastern European region. Regulatory systems are transparent and predictable. Logistics are relatively easy and continuing to improve.

Corruption is minimal. Although the introduction of a rigorous reimbursement system in 2012 halved the pharmaceutical market value, the sector has since recovered, and the reimbursement system has served to increase compliance and access to pharmaceuticals within a system where healthcare is universally available.

As in other areas, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the Ministry of Health play a key role in the market for medicines, medical devices, food supplements and cosmetics.

The relatively transparent and predictable local regulatory procedures still require careful navigation. Only with an understanding of the Polish 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 policy
  • 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
  • Pricing and reimbursement status monitoring and maintenance
  • Timely follow up and communication with experts
  • Administrative support at all levels

MARKET ACCESS POLAND – 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 POLAND – 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 national legislation and regulatory procedures.

Across key product areas of pharmaceuticals/medicines/drugs, 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 (so called Integrated System of Medicinal Products Marketing in Poland)
  • RA support to meet EU serialization and NMVS (National Medicines Verification Systems) guidelines
  • Manufacturing, within which QA and good pharmaceutical manufacturing practice requirements for the Polish market must be met
  • RA consulting services to meet local distribution prerequisites
  • 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 the advertising of medicinal products specifically regulated by Chapter 4 of the Pharmaceutical Law
  • Data protection and GDPR
  • 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