Dietary supplements are products classified as foodstuffs, not as drugs. Therefore, placing them on the market (often mistakenly called registration) are regulated under the Act of 25 August 2006 on Food and Nutrition Safety (Dz.U. 2006 r. nr 171, poz. 12250). Registration of or permit for dietary supplements are not required. It does not mean that the producer of dietary supplements has no limitations. Regulations clearly state conditions that need to be met for the dietary supplements to be placed on the market. A core condition being notification of GIS.
Registration of dietary supplements = GIS notification.
The Chief Sanitary Inspectorate (GIS) supervises placing of dietary supplements on the Polish market. It, therefore, needs to be notified about the initial placement of a dietary supplement on the Polish market.
• Can be filed before or at the moment of the product placement.
• Needs to be submitted on a specific online form available on the GIS website - it must be completed online and sent electronically. If you have an electronic signature or ePUAP, it is enough to send it by electronic means; otherwise, it is necessary to submit the form by post.
• The answer to the notification is not required, however in the event of the notification does not meet legal requirements, GIS can open a verification procedure; and in the case of local sanitary inspection, authorities may, for example, withdraw the dietary supplement from the market.
• Filing a notification, de facto registration of a dietary supplement, allows for legal placement on the Polish market.
• Does not require waiting for a GIS response. However, all requirements set out by Polish and European law should be met, because, in case of doubt, the GIS may initiate an explanatory procedure. In the event of product deficiencies, local sanitary inspection authorities may withdraw the dietary supplement, for example, remove from the market.
Different herbs in glass bottles with coloured liquid
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