Biznes Fakty
GIF withdrew the sleep aid „Zaśnik” from sale
The product „Zaśnik” has been removed from sale, according to a report from the Chief Pharmaceutical Inspectorate (GIF). This item was marketed as a medicinal product, despite lacking the necessary authorization.
According to the press release, GIF „has made a decision to withdraw from circulation in the Republic of Poland the product sold for general use under the name 'Zaśnik’ by Relentless sp. z o. o. based in Poznań”.
It was noted that „this product fits the definition of a medicinal product, yet it has not received approval for marketing as such”.
Product not authorized for sale
The pharmacological characteristics of „Zaśnik” imply a therapeutic benefit. The product is marketed in the form of a diffuser, an aromatherapy device, and contains melatonin, which is found in medicinal products authorized for sale in the country without a prescription.
„The description of this product on various websites includes indications associated with medicinal products. Hence, this item is required to possess a valid marketing authorization for legal sale within the Republic of Poland, yet it was marketed as a dietary supplement,” GIF clarified.
Furthermore, the press release stated that „Zaśnik” is „a medicinal product not authorized for marketing, which has nonetheless been brought to the market and is available for purchase by the general public.”
„Zaśnik” removed from the market
As a result, GIF has opted to withdraw the product from the market. The decision was made with immediate effect.
“It is important to note that only those medicinal products that have undergone a positive safety assessment and are correctly labeled during the registration process are allowed for general sale and use, with purchases permitted solely from licensed and authorized sources,” the press release stressed.
We reached out to the manufacturer for a statement but did not receive a response prior to publication.
