07. How long is there an obligation to create and submit PSURs or RMPs after a marketing authorisation was withdrawn?

After a marketing authorisation is withdrawn there is no requirement for submission of a PSUR with the exception of withdrawn products with conditions/restrictions with regard to the safe and effective use of the medicinal product, in such cases the IMA requires submission of a PSUR.
When a product is withdrawn there are no obligations to create or update an RMP in the dossier for the withdrawn product. However, GVP Module V states the following „For an individual marketing authorisation holder and applicant, all products containing the same active substance should be included in one RMP [IR Art 30(2)] unless separate presentations are requested by the competent authority or agreed by the same at the request of the applicant/marketing authorisation holder.“ Therefore, if the relevant RMP covers other products than the withdrawn one, the RMP needs to be updated to reflect that one product was withdrawn. The dossier for each product (apart from the withdrawn product) needs to be updated accordingly at the next regulatory opportunity.

Last updated: December 17, 2021
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