Registering a dietary supplement with GIS — a guide for brand owners (2026)
Before a supplement goes on sale in Poland, you must notify the Chief Sanitary Inspectorate (GIS). We explain what notification involves, what documentation it requires, and where brands most often go wrong.
Note: this article is informational and gives a general picture of the procedure. Detailed requirements may change — for a specific product it's worth confirming the current legal status or using regulatory support.
What GIS notification is
In law, a dietary supplement is food, not medicine. So it does not go through the authorization procedure known from the pharmaceutical market. Instead, notification applies: the entity that first places the product on the market in Poland is obliged to notify the Chief Sanitary Inspector.
The key distinction: notification is a report of the fact that a product has been placed on the market, not an official confirmation of its safety. It is the manufacturer and the entity placing the product on the market who are responsible for ensuring the composition, doses and labeling comply with the regulations.
The procedure step by step
- Determining the product's status. Confirming that the product qualifies as a dietary supplement, and checking the ingredients — whether any is, for example, a novel food (Novel Food) requiring separate authorization.
- Preparing the composition and label. Establishing the quantitative composition, the doses of vitamins and minerals and the claims, then designing a compliant label.
- Gathering documentation. Raw-material specifications, test results and documents confirming quality and safety.
- Submitting the notification to GIS. The responsible entity notifies the product together with the label template.
- Possible clarification proceedings. GIS may request additional information or an opinion, e.g. when the composition raises doubts.
- Placing on the market. Once the notification obligation is fulfilled, the product may be sold, subject to ongoing obligations regarding quality and labeling.
Required documentation and labeling
Labeling matters most in practice — it most often decides whether the notification goes smoothly. The table below organizes the typical elements.
| Area | What to watch for |
|---|---|
| Quantitative composition | The content of active ingredients and compliance with permitted levels. |
| Name and qualification | A clear “dietary supplement” designation and a correct product name. |
| Claims (health claims) | Only claims compliant with applicable EU regulations are permitted. |
| Dosage and warnings | The recommended serving, a warning not to exceed the dose, and a statement that the supplement does not replace a diet. |
| Allergens | Correct allergen labeling and, if needed, information about line cleanliness. |
Common mistakes
- Impermissible health claims — promises going beyond approved health claims.
- Exceeded doses of vitamins or minerals above permitted levels.
- An overlooked Novel Food status of an ingredient that requires separate authorization.
- Errors in allergen labeling or missing required warnings.
- Starting sales before fulfilling the notification obligation.
How Onesano helps
As a contract manufacturer, we guide the client through the whole regulatory process: GIS notification, compiling documentation, required testing, and the assessment and verification of label compliance. This means the brand doesn't have to interpret the regulations on its own — on the formal side, the product is prepared in parallel with production. See how registration fits into the whole contract manufacturing process.
Frequently asked questions
Does a dietary supplement require registration before sale?
Yes. Before placing a supplement on the market in Poland you must notify the Chief Sanitary Inspector (GIS) — the so-called notification. The notification is made by the entity responsible for placing the product on the market.
Is GIS notification the same as product authorization?
No. Notification is a report of placing the product on the market, not an authorization decision. Responsibility for the supplement's safety and compliance rests with the entity placing it on the market.
Does Onesano help with supplement registration?
Yes. We provide full regulatory support — guiding the client through GIS notification, complete documentation, required testing, and assessment of label compliance.
We'll handle production and the regulatory side
From formula to GIS notification — we'll guide your product through the whole process.
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