Publication of applications approved by Swissmedic for the temporary placing on the market of a medicinal product authorised in Switzerland in packaging intended for another country
If a therapeutically important medicinal product authorised in Switzerland is temporarily unavailable as a result of a supply shortage (stock-out situation), the authorisation holder may submit an application for the temporary placing on the market of the identical product (in terms of qualitative and quantitative composition) in packaging intended for another country under the terms of Art. 9 b, para. 2, Art. 58, Art. 66 para. 1 and 2 and Art. 67 para. 1 and 2 TPA. The application for temporary placing on the market can be approved if the availability of the medicinal product is therapeutically important, if it can be assumed that there is no increased risk with regard to the safety of medicines and if no equivalent alternative product is available in Switzerland.
The approval of these applications and the associated customer information letters will in future be published on the Swissmedic website in the Market Surveillance section.
For further information on the relevant requirements and the submission of an application for the temporary placing on the market of a medicinal product authorised in Switzerland in packaging intended for another country, please see the following information sheet.