Reference product HMG Art. 14, para. 1, letter abis-ter

Can Article 14 medicinal products be used as reference medicinal products?

Medicinal products authorised in accordance with Article 14, para. 1, letter abis-ter HMG are based on a foreign reference product for which Swissmedic does not have complete documentation with regard to efficacy and safety. A condition for a Swiss reference medicinal product is that it has been authorised by Swissmedic based on a complete dossier. For this reason, Article 14 products cannot be used as reference medicinal products for further known APIs or authorisation extensions.

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Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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