Swissmedic clarifies in the authorisation forms how to describe the indication of the medicinal product and simplifies the standardised consents for sharing information with partner authorities.
Update to the forms New authorisation of human medicinal products and Variations and authorisation extensions HAM
02.07.2024
Swissmedic publishes various information on complete applications for authorisation, extension of the indication or extension of the authorisation of a medicinal product within 60 days of their receipt (Art. 68 para. 1 let. a of the Therapeutic Products Ordinance, SR 812.212.21).
Swissmedic publishes the required information on the indication unchanged from the version submitted by the applicant in the forms New authorisation of human medicinal products and Variations and authorisation extensions HAM. Swissmedic has noted that the level of detail of this information varies greatly, and that the information provided is insufficient in some cases. To ensure adequate information for the public, clarification has therefore been provided on how to describe the indication in section 1 Basic information of the forms.
In future, applicants should either provide the proposed wording of the indication or a summary including the following information in the application:
- Specification of the disease (molecular subtype if applicable)
- Target population
- Specification of the line (if applicable)
- Specification of the type of prior therapies (if applicable)
- Specification of whether it is monotherapy or to be used in combination with other active substances (if applicable)
If applicants claim there is commercially confidential information in the formulation of the indication, the cumulative, case-specific requirements will apply (see explanations in the Guidance document SwissPAR); the legitimacy of these will be checked by Swissmedic (Art. 68 para. 2 TPO).
Swissmedic has also simplified the consent to sharing information with partner authorities (sections 7.7 and 6.8, respectively) in the two forms, and deleted sections 7.8 and 6.9, respectively, as COVID-19 Ordinance 3 (SR 818.101.24) ceases to apply at the end of June 2024.
The revised forms are valid with effect from 1 July 2024.