Should Swissmedic decide, in reviewing an authorisation application, that the data provided are not sufficient for an ordinary authorisation, it is permitted – on the assumption that it meets the criteria set forth in Article 18 TPLO – to issue an “ex officio” temporary authorisation.
As of now, this progression to a temporary authorisation can be performed in a single step. To do so, Swissmedic issues a “preliminary notification of rejection” for the ordinary authorisation along with partial approval for the temporary authorisation. In its reply to the preliminary decision, the applicant states whether it is for or against an ex-officio temporary authorisation, submitting both its reasons and the required documentation.
For a detailed description of this simplified procedure, see section 7 of the guidance document Temporary authorisation of human medicinal products HMV4.
The adapted guidance document comes into effect on 1 January 2022.