If an ODS is applied for on the basis of a corresponding status granted abroad (= reference country), the authorisation holder is obliged to inform Swissmedic of all decisions regarding the granting of ODS taken in other countries with comparable medicinal product control within the meaning of Art 13 TPA.
Not only the reference country should be listed in section 3.3 of the form Recognition of orphan drug status, but also the other countries with comparable medicinal product control where an ODS was granted. The date of ODS recognition and authorisation (if available) must be stated for both the reference country and the other countries with comparable control, and copies of the decisions must also be enclosed (mandatory for Art. 4 para. 1 let. adecies no. 2 TPA). The scientific documentation submitted to the reference authority on which the ODS is based and which proves fulfilment of the ODS criteria must be submitted in full, including all references cited. This is not necessary for the other countries; the decisions are sufficient in this case.
Find out what you need to consider when transferring ODS status to another company in a further “Hot Topics” article.
