Decision C-2733/2021 of 23 April 2024

3 mai 2024 – In its decision of 23 April 2024, the Federal Administrative Court dismissed the appeal of a pharmaceutical company (appellant), against a ruling of the Swiss Agency for Therapeutic Products (Swissmedic) concerning the marketing authorization of an herbal medicinal product.

The pharmaceutical company applied for a modification of the marketing authorization of its herbal medicinal product B. with regard to the patient information. Inter alia, the appellant requested to amend the patient information with a reference to the origin of the plant material used in the medicinal product. Swissmedic approved the variation, subject to certain conditions, including the removal of the reference to the origin of the plant material.

The appellant argued that the reference to the origin of the plant material was not an advertising statement and was important for the patient's information. Swissmedic on the other hand argued that the reference was an advertising statement and not relevant to the patient's information.

The court did not rule on whether or not the reference to the origin of the plant material was an adverting statement. The court only found that the reference could lead patients to believe that the product was of superior quality, although there was no evidence to support this claim. According to the court, this fact alone justified Swissmedic's decision. The court dismissed the appeal.

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