01
Choose the target market
Start with the market in which the product is intended to be placed. Notification and market-entry requirements are jurisdiction-specific.
POLAND-FIRST MARKET-ENTRY EDUCATION
The operator first defines the product category, composition, product form and Polish label information, then submits the required notification to GIS through the official electronic system before the planned first placement on the Polish market. The notification is not a universal product approval: responsibility for the product remains with the operator, and GIS may begin explanatory proceedings or seek additional opinions.
This page is an educational overview of the official Poland-first process, not legal advice or a promise of market access.
PROJECT SEQUENCE
01
Start with the market in which the product is intended to be placed. Notification and market-entry requirements are jurisdiction-specific.
02
For the Poland-first route, the official process calls for the product category, composition, product form and Polish label information.
03
Before planned first placement on the Polish market, the operator submits the required notification through the official GIS electronic system.
04
A notification is not a universal product approval. The operator remains responsible for the product and may need to respond to an authority process or additional questions.
EU CONTEXT
Food supplements are regulated as foods in the European Union, and Member States may require notifications for market monitoring. Requirements differ by jurisdiction, so classification, label and notification decisions require review for the relevant project and market.
Read the European Commission food-supplements guidance →WHERE OLYMPIA BIOSCIENCES™ FITS
Olympia Biosciences™ can help a project become technically and commercially ready for the appropriate regulatory workstream. Market-entry, classification, label and notification decisions require project-specific review; FSMP and medical-nutrition programmes follow bespoke scoping.
INITIATE R&D DUE DILIGENCEStrictly B2B / Educational R&D Disclaimer
The pharmacokinetic data, clinical references, and scientific literature referenced on this page are provided strictly for B2B formulation, educational, and R&D purposes for medical professionals, pharmacologists, and brand developers. Olympia Biosciences™ operates solely as a Contract Development and Manufacturing Organization (CDMO) and does not manufacture, market, or sell consumer end-products.
Global Regulatory & No Health Claims. Nothing on this page constitutes a health claim, medical claim, or disease-risk-reduction claim within the meaning of EU Regulation (EC) No 1924/2006, the U.S. Dietary Supplement Health and Education Act (DSHEA), or other global regulatory frameworks. These statements and raw data have not been evaluated by the Food and Drug Administration (FDA), European Food Safety Authority (EFSA), or Therapeutic Goods Administration (TGA). The raw active pharmaceutical ingredients (APIs) and formulations discussed are not intended to diagnose, treat, cure, or prevent any disease.
Client Responsibility. The B2B client who commissions a formulation from Olympia Biosciences™ bears full and sole responsibility for all regulatory compliance, health claim authorization (including EFSA Article 13/14 claim dossiers and U.S. FDA notifications), labeling, and marketing of their finished product in their target market(s). Olympia Biosciences™ provides manufacturing, formulation, and analytical services only.