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Swissmedic: Changes of the full declaration form effective 1 January 2025

1 January 2025

Swissmedic: Changes of the full declaration form effective 1 January 2025

Swissmedic has announced that as of 1 January 2025, the full qualitative declaration of the composition of flavors and fragrances (aromatic substances) in human and veterinary medicinal products will no longer be mandatory. Experience gained during the implementation of the previous regulations has demonstrated that the full declaration of flavors and fragrances with complex compositions did not provide significant added value for Swissmedic’s assessment process. Consequently, the requirements have been aligned with those of the European Union (EU). Moving forward, a generalized qualitative declaration will suffice, specifying the primary ingredients and any excipients of particular interest according to Annex 3a of the Medicinal Product Authorization Ordinance (Arzneimittel-Zulassungsverordnung, AMZV) for human medicinal products or safety-relevant excipients for veterinary medicinal products.

For more information, see here.

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