A reduced assessment in accordance with Art. 13 TPA for an application for authorisation or variation of a medicinal product is possible, provided that the documentation requirements according to Art. 16 TPO are fulfilled. Swissmedic has amended the guidance document to include the stipulation that the indication wording for the medicinal product for which an authorisation or indication extension is being applied for must be identical to the indication wording approved by the foreign reference authority.
Conditions imposed by the reference authority that have not yet been fulfilled by the time of the authorisation decision by Swissmedic are usually also imposed by Swissmedic. Applications for exemption from the conditions imposed by the foreign reference authority and also ordered by Swissmedic may now only be submitted to Swissmedic once the reference authority's decision is known. So that Swissmedic can base its own decisions on those of the foreign authorities, the documentation submitted to the reference authority and, where applicable, the corresponding Assessment Report must be submitted.
Other amendments to the guidance document include clarifications relating to the submission of RMPs and RMP updates.
The revised guidance document Authorisation of human medicinal products under Art. 13 TPA takes effect on 15 January 2024.