GIS Notification in Poland: Step-by-Step Guide for Supplement Manufacturers

GIS notification Poland is not mainly a form-filling exercise—the more useful starting point is understanding what happens after the Official Confirmation of Receipt is issued. Submitting the electronic filing appears straightforward, but the primary risk lies in how the Chief Sanitary Inspectorate (Główny Inspektorat Sanitarny, GIS) handles post-notification scrutiny, where a triggered explanatory proceeding can suspend distribution or force product reclassification.

The mistake rarely appears at the moment of submission. It surfaces months later, when a market surveillance sample or a competitor complaint prompts GIS to open an explanatory proceeding on a product already generating revenue, and the FBO discovers that the notification file—composition details, label basis, ingredient evidence—was not built to withstand that level of scrutiny.

If you are still deciding the broader entry structure—entity setup, labelling strategy, advertising rules—start with our main guide on dietary supplements in Poland. This page focuses more narrowly on the notification procedure itself: who files, what the form requires, what the UPO actually confirms, and how GIS explanatory proceedings operate in practice.

Table of Contents

• What Is the GIS Notification and Who Is Required to File?
• Step-by-Step Guide to Submitting a Supplement Notification in Poland
• Required Information and Documentation for GIS Filing
• Understanding GIS Explanatory Proceedings
• EU Mutual Recognition vs. Polish GIS Scrutiny
• Common Misunderstandings About GIS Notification
• How CGO Legal Assists Foreign Companies with GIS Compliance
• FAQ – GIS Notification Poland
• Explore the Life Sciences & Healthcare Cluster

What Is the GIS Notification and Who Is Required to File?

Under Articles 29–31 of the Act on Food Safety and Nutrition (Ustawa o bezpieczeństwie żywności i żywienia) of 25 August 2006, any entity placing a dietary supplement on the Polish market for the first time must submit an electronic notification to GIS. This is a notification system, not a pre-market registration in the pharmaceutical sense: the filing is procedural, informing the authority that a product is entering the market, rather than seeking prior approval of its composition.

The obligation applies at the moment of first placement on the territory of Poland—regardless of whether the product is already sold under the same formula elsewhere in the EU. A separate Polish filing is generally required even where the product has previously been notified to the competent authority of another member state; the prior notification is referenced in the Polish filing, not substituted for it.

The party responsible for filing is the Food Business Operator (FBO)—the entity whose name appears on the label as responsible for the product information—and that entity must generally be established within the EU/EEA. A company based outside the EU cannot file directly under its own foreign entity; it must act through a Polish subsidiary, an EU branch, or an authorized local representative empowered to submit the notification and receive GIS correspondence on its behalf.

Step-by-Step Guide to Submitting a Supplement Notification in Poland

The notification process runs through five practical stages, each with a different risk profile.

1. Preparation of product documentation and the Polish draft label. The manufacturer or FBO compiles the full composition, dosage form, and a Polish-language label draft consistent with the requirements under Regulation (EU) 1169/2011.
2. Verification of ingredients against Polish maximum daily dose limits and restricted botanical lists. Before filing, the composition should be checked against the maximum permitted levels for vitamins and minerals and the list of botanical substances restricted or prohibited in Poland, as maintained with input from the GIS Dietary Supplements Team (Zespół do spraw Suplementów Diety).
3. Electronic submission via the GIS notification portal. The notification is filed as an electronic document through the dedicated GIS system, generally accessed via the e.sanepid platform or ePUAP, using the standard notification form.
4. Receipt of the Official Confirmation of Receipt (UPO). Once the filing is accepted, GIS issues the Urzędowe Poświadczenie Odbioru (UPO), the electronic confirmation that the notification has been lodged. The date of receipt of the notification is treated as the operative filing date.
5. Monitoring the GIS register status. Filing is not the end of the compliance obligation. The FBO should track whether GIS raises any follow-up queries or opens an explanatory proceeding, and should keep the notification file—composition, label, supporting evidence—readily available for as long as the product remains on the market.

Required Information and Documentation for GIS Filing

The GIS electronic notification form generally requires the following data points:

• Product name, exactly as it will appear on the Polish market.
• Manufacturer details, including the name and address of the entity producing the supplement.
• Qualitative and quantitative composition, listing each active substance and its amount per recommended daily portion.
• Dosage form (postać)—capsule, tablet, sachet, liquid, or other presentation.
• Draft Polish-language label, reflecting the final packaging as it will be sold.
• Details of the notifying party (FBO), including its EU/EEA registered address and the basis of its authority to file (owner, importer, or authorized representative).
• Where applicable, reference to a prior notification in another EU member state, including the name of the competent authority and a copy of that state’s confirmation.

Errors at this stage—an inconsistent ingredient list, a label that does not match the notified composition, or missing FBO details—are among the most common reasons a routine notification attracts GIS follow-up.

Understanding GIS Explanatory Proceedings

The explanatory proceeding (postępowanie wyjaśniające) is the mechanism through which GIS exercises substantive scrutiny after a notification has already been filed and the product is on the market. It is generally opened when GIS has doubts about a product’s classification or composition—for example, where a vitamin or mineral dose exceeds accepted limits, a botanical ingredient appears on a restricted list, or the product’s presentation suggests a pharmacological rather than nutritional function.

What GIS can do during a proceeding

Once opened, GIS may request additional documentation or clarification directly from the FBO or its representative, seek a scientific opinion from the GIS Dietary Supplements Team on the contested ingredient or dosage, or refer classification questions to the Office for Registration of Medicinal Products (Urząd Rejestracji Produktów Leczniczych, URPL) where the product may fall into a borderline product category between food supplement and medicinal product. Where the proceeding confirms non-compliance, GIS can issue a decision restricting or prohibiting further sale of the product.

How to respond effectively

Responding effectively to a GIS explanatory proceeding generally means engaging early, providing complete scientific and documentary support for the contested point, and treating the correspondence as a formal administrative matter rather than a routine information request. An inadequate or delayed response can accelerate the case toward a restrictive decision, since GIS operates under administrative procedural rules that move the case forward on a defined timeline regardless of whether the FBO is actively engaged.

EU Mutual Recognition vs. Polish GIS Scrutiny

A recurring misconception among foreign brands is that a product already lawfully sold in Germany or France cannot be challenged in Poland, on the assumption that EU mutual recognition guarantees automatic market access. In practice, mutual recognition operates as a rebuttable principle, not an absolute shield.

Under the mutual recognition framework, a product lawfully marketed in one EU member state should generally be accepted in another, unless the receiving state can justify a restriction on grounds such as public health protection. GIS can, and does, open explanatory proceedings on products already notified and sold elsewhere in the EU, particularly where Polish authorities take a different view on dosage limits, permitted botanical substances, or the borderline classification of the product.

A prior EU notification is a relevant reference point in the Polish filing and in any subsequent proceeding—it is evidence to be relied upon, not a guarantee that displaces Polish review. Foreign brands with a product portfolio already established elsewhere in the EU should generally treat the Polish notification as an independent compliance exercise, cross-checking composition against Polish-specific limits before relying on cross-border precedent.

Common Misunderstandings About GIS Notification

• The UPO is not a market approval. Receiving the Official Confirmation of Receipt confirms that the notification was lodged—it does not confirm that GIS has reviewed or approved the product’s composition. An explanatory proceeding can be opened at any point after the UPO is issued, including long after the product is generating revenue on the Polish market.
• An EU notification in another member state does not substitute for Poland. The Polish filing must be made separately, referencing the prior notification rather than replacing it. Placing a product on the Polish market without a separate GIS filing—even if the product is already notified in Germany, France, or elsewhere—is generally treated as a violation of Article 29 of the Act on Food Safety and Nutrition.
• EU mutual recognition does not prevent Polish explanatory proceedings. A product lawfully marketed in another EU member state can still be subjected to a GIS explanatory proceeding in Poland, particularly where dosage limits or botanical ingredient rules differ under Polish interpretation.
• A non-EU company cannot file directly. The FBO identified in the notification must be established within the EU/EEA. A non-EU manufacturer cannot use its own foreign entity for the Polish filing; it needs a Polish subsidiary, EU branch, or authorized local representative.
• Notification is an ongoing obligation, not a one-time filing. Once filed, the FBO retains responsibility for monitoring GIS correspondence, updating the notification if the formula or label changes materially, and maintaining the full documentation file as long as the product is on the market.

How CGO Legal Assists Foreign Companies with GIS Compliance

Our Regulatory & Corporate practice supports manufacturers and distributors through the GIS notification lifecycle. The work typically begins before filing rather than after a proceeding has opened, since a pre-notification composition and label audit is considerably more efficient than correcting a non-compliant notification under active GIS scrutiny.

On the pre-notification side, we handle composition and label audits, identifying dosage or ingredient issues against Polish maximum limits and restricted botanical lists before the filing is made. We also manage preparation and electronic submission of the GIS notification, including coordination with an authorized local representative where the FBO is not yet established in Poland.

Where a proceeding is already open, we provide representation in GIS explanatory proceedings—including responses to information requests, coordination on borderline classification questions with URPL, and, where relevant, supporting the FBO through the administrative process through to its conclusion.

FAQ – GIS Notification Poland

Written by the Regulatory & Corporate Law Practice Team at CGO Legal | Last updated: July 2026

This article provides general information on the GIS notification procedure for dietary supplements in Poland and does not constitute legal advice. Outcomes of GIS review and explanatory proceedings are assessed on a case-by-case basis; foreign companies should seek dedicated legal review before filing a specific product notification.