For co-marketing medicinal products, the same medicinal product information that is used for the basic product needs to be used. That means that in the case of both new authorisations and variation applications for co-marketing medicinal products, the medicinal product information valid at that time for the basic product has to be adopted. This specifically applies in those cases where the medicinal product information of the basic product has yet to be adapted to the revised TPLRO at the time when the authorisation of the co-marketing medicinal product is renewed,. Co-marketing products are therefore not affected by the deadlines* specified for adaptations to the revised legislation. *No later than by the next authorisation renewal due.
This rule does not apply to generics.
