Negative declaration and medicinal product advertising

Is a negative declaration permitted in advertising to health care professionals and the general public?

With the entry into force of the revised Therapeutic Products Act on 1 January 2019, the negative declaration of excipients in packaging texts or in the medicinal product designation is no longer permitted (Guidelines on packaging for medicinal products for human use HMV4). Swissmedic also classifies negative declarations in medicinal product advertising (advertising to specialists and the general public) as not permissible in advertising elements. This is because, according to the Ordinance on Advertising of Medicinal Products (AVW) (German, French and Italian only), advertising to the general public must be in accordance with the text on the outer package last approved by Swissmedic. Negative declarations do not correspond to the approved packaging text and are therefore not tolerated (Swissmedic Journal 09-2018 p.818) (German & French versions only).

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Any questions?
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Dr. Katharina Oehler
Scientific and Managing Director

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