Strategic Regulatory Partner for Success in Poland

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

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Greetings from
Freyr Poland

Situated in Central Europe, Poland stands a good access point for other regions in Europe. In addition, Poland’s steadily growing economy predominantly boasts a good fortune for foreign medicine and medical devices manufacturers for investments. However, the health sector is highly regulated and the Ministry of Health oversees the regulations regarding necessary market authorizations and market approvals. In addition, lack of profound knowledge on local regulatory rules would pose a great challenge for manufacturers to sail through the approval procedures.

Freyr, as an exclusive global Regulatory partner, assists foreign manufacturers to navigate through complex Regulatory procedures in Poland. Right from invaluable market insights to obtaining end-to-end market authorizations, Freyr’s Regulatory services in Poland span across:

Industries We Serve in Poland

Poland has the largest Pharmaceutical market in Central and Eastern Europe and a structured healthcare system boasting good market opportunities for aspiring medicinal product manufacturers. For compliant market access, manufacturers must register their medicinal products with Chief Pharmaceutical Inspectorate of Poland. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:

Poland is an emerging market for food supplements in the European Union (EU), attracting significant interest from industry companies. Food supplements in Poland are governed by the Polish Act of August 25, 2006, implementing Directive 2002/46/EC. Simply classifying food as a food supplement in other markets is insufficient for it to be considered a Food Supplements in Poland or the EU. Compliance with permitted substances, maximum levels, and banned substances in Polish food supplements is crucial. Accurate food labeling, advertising, and health claims verification are necessary to ensure safety and avoid sanctions, product withdrawal, and recalls.

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Marketing authorizations maintenance: Variations, renewals, notifications
  • End-to-end Regulatory submissions
  • Preparation of eCTD and NeeS and dossier publishing
  • Dossier Management, Dossier Audit
  • Consultancy services for European procedures (MRP, DCP) and national procedure
  • PIL readability testing/PIL user testing according to EU guidelines
  • Preparation and translation of Summary of Product Characteristic (SmPC)
  • Patient Information Leaflet (PIL)
  • Labeling including Braille
  • ICH-Good Compliance Practice (GCP)
  • CE Marking
  • Pharmacovigilance

Freyr Advantages

  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines

Our Location in Poland

35 Poleczki,
Str. 02-822 Warsaw,
Poland