Extended option for applying the procedure with prior notification (PPN) – PPN now also applicable for Art. 12 para. 4 TPLO preparations

08.07.2017 - As a new option, it will now also be possible to employ the PPN to the new authorisation, and new indications, of human medicinal products with known active substances which, according to Art. 12 para. 4 TPLO, cannot be authorised via the simplified procedure. This option is subject to the availability of the necessary Swissmedic personnel during the relevant timeframe. As is already possible with first authorisations of human medicinal products with a new active substance (NA NAS HMP) and their new indications (NI) in the PPN, the above-mentioned applications can now be processed by Swissmedic 20% faster if the request is approved, provided the applicant is prepared, in return, to pay double the all-inclusive fee (Art. 5 para. 1 in conjunction with Annex 2 A, section 2 FeeO). The corresponding guide to Procedure with prior notification has been modified and will enter into force in its revised form on 1 July 2017.