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.
1. Holders of authorisation for a co-marketing medicinal product are required to notify all variations to the basic product (application type A.101 – Adaptation of a co-marketing medicinal product to ensure alignment with the basic product). Does this apply to variations that should not have been submitted at all?
2. We intend to apply for authorisation of a co-marketing medicinal product in the near future and have several questions on the new requirements. The new requirements set out in the TPLRO have not yet been applied to the basic product. Given that the co-marketing product has to be identical to the basic product, we would like to know whether we can now apply for authorisation of the co-marketing product using texts that do not comply with the new requirements, or if we have to wait until the new requirements have been applied to the basic product before we can submit our application for authorisation of the co-marketing product?
3. From when does the Italian Information for healthcare professionals have to be published for the co-marketing product? Is the date determined by the due date for renewal of authorisation?
4 How and when should modifications under the revised TPLRO be made to co-marketing medicinal products? Is the date determined by the due date for renewal of authorisation? Revised in July 2022
5. We would like to submit an application A.106 Conversion of the authorisation of co-marketing medicinal products to independent authorisation (basic product). How should the formal requirement “Submission of a complete, identical set of documentation” be interpreted? New from February 2023
6. How should the declaration of consent from the authorisation holder of the basic product mentioned in section 3.11.2 of the guidance document Formal requirements be formulated? New from February 2023
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).
Swissmedic understands a complete set of documentation to refer to the entire life cycle of the basic product, i.e. including all submissions in chronological order from application to first authorisation of the basic product.
As an alternative to submission of the complete set of documentation, if there is a relevant declaration of consent from the authorisation holder of the basic product, only the actually approved documentation (Module 2 to Module 5) and any forms to be amended from Module 1 can be submitted, see section 3.11.2 of the guidance document Formal requirements.
The marketing authorisation holder of the basic product must give an appropriately formulated declaration of consent to Swissmedic as the regulatory authority stating that it is making available the scientific documentation on the product. For example: “The marketing authorisation holder of the basic product [...] hereby gives its consent to Swissmedic for its scientific documentation for the basic product [...] being placed on file in the process regarding conversion of the co-marketing medicinal product [...] to a regular authorisation.”
Last modification 13.02.2023