On 01.09.2021, Swissmedic updated the forms for New authorisation of human medicinal products HMV4 and Variations and authorisation extensions HMV4.
In Project Orbis, pharmaceutical companies are able to simultaneously submit oncological authorisation applications to the FDA and to other participating international regulatory authorities (including Swissmedic).
For the purpose of obtaining consent to exchanging information, the relevant sections of the forms New authorisation of human medicinal products HMV4 (section 7.9) and Variations and authorisation extensions HMV4 (section 6.10) has been amended accordingly.
Applications for authorisation or modification of radiopharmaceuticals can be assessed both in Project Orbis and within the framework of the collaboration with partner authorities of the International Regulators Consortium.
To ensure that applicants are able to consent to the exchange of information, the following sections in these forms have been amended:
Sections 7.7 and 7.9 in form New authorisation of human medicinal products HMV4 (link)
Sections 6.8 and 6.10 in form Variations and authorisation extensions HMV4 (link)
The amended forms are valid as of 1 September 2021.