Art. 13 and Art. 14, Para. 1, Letter abis TPA (= Therapeutic Products Act)

Can Art. 14, Para. 1, Letter abis TPA be combined with Art. 13 TPA?

If a product has already been approved in the EU for at least 10 years, this product can, in accordance with Art. 14, Para. 1, Letter abis TPA, be a reference medicinal product for the medicinal product submitted in Switzerland. If the medicinal product, for which an application for marketing authorisation is to be submitted in Switzerland, is a generic of the reference medicinal product in the EU, which has been recently approved in the EU (dossier <5 years), the application of Art. 13 TPA could, in theory, also be applied for. A combination of Art 14, Para. 1, Letter abis TPA and Art. 13 TPA, according to Swissmedic, is not possible, however.

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Dr. Katharina Oehler
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