On 1 July 2026, the revised Annex 3a of the Ordinance on the Licensing Requirements for Therapeutic Products (TPLRO) will enter into force. Polysorbates are newly listed as excipients of particular interest for parenteral and topical use.
Polysorbates are widely used as excipients, particularly in biological and biotechnological medicinal products.
Marketing authorisation holders of human medicinal products must review their product information texts and packaging materials for compliance with the new requirements and submit any necessary amendments to Swissmedic (variation E.100 b), type IB).