A number of points in the Guidance document Import of a medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) have been further clarified or amended.
An application for the authorisation of a parallel-imported human medicinal product can only be submitted if the original medicinal product was already authorised in Switzerland at the time of submission. The requirements with regard to quality, safety and efficacy following market launch have been further clarified. For example, if there are safety signals or quality defects relating to the original medicinal product (e.g. increased nitrosamine levels), the importer may be obliged to implement risk-minimising measures.
The number of samples to be submitted has been reduced to 1 sample pack per dosage strength.
The specifications regarding the GTIN code and batch number are now set out in greater detail: the Swiss authorisation number and the packaging code must always be stated, either as part of the GTIN code or in a separate text. Further clarifications relate to the marketing authorisation status, such as the implications of revocation or suspension of authorisation of the original medicinal product for the parallel-imported medicinal product, and the consequences resulting from sales of the original medicinal product being interrupted.
The amended guidance document Import of a medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) and the amended form Import of a medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import) are valid from 1 May 2025.