Variations that can be applied autonomously to the basic product do not have to be notified to Swissmedic for the co-marketing medicinal product. This applies even if the holder of authorisation for the basic product submits applications for variations that should not even have required approval/should not have been notified.
You do not have to wait until the basic product is up to date to submit your new application for authorisation of the co-marketing medicinal product. You can submit the co-marketing medicinal product on the basis of the current (not yet updated) texts for the basic product. As soon as the basic product has been updated, Swissmedic must be notified of the variations to the co-marketing product.
The Italian Information for healthcare professionals for the co-marketing product should be published after the Information for healthcare professionals for the basic product. This means that timing is not geared to the renewal of authorisation (similarly to modifications under the revised TPLRO).
Co-marketing medicinal products are a special case here, i.e. the modifications under the revised TPLRO are not linked to renewal. As soon as the modifications under the revised TPLRO have been implemented for the basic product, the corresponding variations also have to be implemented by means of a type IAIN variation: Adaptation of a co-marketing medicinal product to ensure alignment with the basic product, A.101 b).
Last modification 16.06.2022