Drug trade suspended. GIF gave reasons for urgent decision

• A negative test result was found for the "appearance" parameter for Sunitinib Vipharm drug samples, despite meeting the other quality parameters
• The marketing authorisation holder, Vipharm SA, informed GIF that the changed appearance of the capsule filling does not affect the quality and effectiveness of the drug and can be safely used
• He declared the introduction of a change to the specification, initially qualifying it as a type IA change, and then reclassifying it as type IB following the opinion of the President of the Office for Registration of Medicinal Products,
• GIF considered that the explanations of Vipharm SA are insufficient because the change in the quality specification regarding the description of the appearance has not yet been assessed and approved by the President of the Office for Registration of Medicinal Products.
• A negative test result for one batch affects the assessment of the justification for keeping all batches of the drug on the market, which poses a real and direct threat to the health of patients.

On June 5, 2025, the Chief Pharmaceutical Inspector issued a decision to suspend nationwide trade in the medicinal product Sunitinib Vipharm (Sunitinibum) in the following doses:

in the form of hard capsules covering all series. These decisions were given immediate enforceability . The entity responsible for this medicine is Vipharm SA from Ożarów Mazowiecki.

The reason for the suspension of trade is a reasonable suspicion that the product does not meet the quality requirements established for it . After the first introduction of the drug to the Polish market on December 13, 2024, the Chief Pharmaceutical Inspector referred it for quality testing. The National Institute of Medicines, acting as the Official Drug Control Laboratory, after testing a product sample (e.g. series 4TY01A for 50 mg) found a negative result in terms of the "appearance" parameter. The remaining quality parameters were met.

On April 10, 2025, Vipharm SA provided explanations and indicated that the changed appearance of the capsule filling does not affect the quality and effectiveness of the drug and that it can be safely used by patients . The company also informed about the planned change in the specification of the product's appearance, initially classified as a type IA change. However, the president of the Office of Medicinal Products, Medical Devices and Biocidal Products, in his opinion of May 6, 2025, questioned this classification: he stated that the change requires analysis and assessment of the data presented. In response, on May 21, 2025, the responsible entity reclassified the reported change to a type IB change.

GIF considered that the explanations of Vipharm SA are insufficient to withdraw from the suspension of trade, especially since the change in the quality specification regarding the description of appearance has not yet been assessed and approved by the President of the Office . It was emphasized that quality tests of products introduced to the market for the first time are preventive in nature, aimed at protecting patients from products that do not meet the requirements. The decision covers all batches of the medicinal product, because a negative test result of one batch affects the assessment of the justification for leaving all batches on the market.

The decision to be immediately enforceable is justified in order to protect the health of patients. Any exceedance of the acceptance criteria for quality parameters, established on the basis of safety studies, constitutes a real and direct threat to health until the lack of such impact is proven. The decision is of a protective nature, suspending trade for the duration of further explanatory proceedings. Vipharm SA must immediately take actions specified in the regulations on suspending and withdrawing products from trade. The party may submit an application for reconsideration of the case to the GIF within 14 days or file a complaint to the Voivodship Administrative Court in Warsaw within 30 days. Filing an application does not suspend the execution of the decision.

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