Re-registration and renewals
After an active substance has been approved for a specific PT, products authorised under transitional law, containing this substance and authorised for the same specific PT, need to be re-registered under the BPR.
Re-registration dossiers need to be submitted by the approval date of active substance the latest, in order to stay on the market until the re-registration process is completed (for a maximum of 3 yrs). In case a product contains more than one active substance, the application must be submitted no later than the date of approval of the last active substance for the relevant PT.
An application for re-registration should contain the same active substance(s) as the original application and contain PT’s approved for the ‘active substance - PT combination’.
You are kindly requested to submit an overview of the national authorizations/registrations re-registered under the BPR (a template can be found at the ECHA website). Only these products are covered by the transitional measures under article 89 of the BPR.
In case it is not clear for Ctgb which R4BP application is used for re-registration, you will be asked to inform us about the case number.
After the approval of an active substance for a specific PT has been renewed, products containing the active substance and authorised for the same specific PT should be renewed as well.
In case, beyond the control of the holder of a national authorisation, no decision for the product authorisation is taken before its expiry, the receiving competent authority shall grant a renewal for the period necessary to complete the evaluation.