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

Medicinal products authorised in accordance with Article 14, para. 1, letter a^bis-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.