On 27.04.2021, ANSES published an update of its note on the grace periods granted and deadlines to update labels in case of withdrawal, amendment or non-renewal of a marketing authorisation or a parallel trade permit for plant protection products.
The update concerns the amendment of conditions for setting grace periods or the addition of new cases involving the determination of the grace periods.
Thus, in the case of a withdrawal of a marketing authorisation or a permit, following the expiry of the active substance approval, grace periods of 6 and 12 months are established for respectively the sale and distribution and for the storage and use of the existing stocks, except for cases where ANSES is aware of harmful effects of the product on human or animal health or of unacceptable effects on the environment (Case n°1).
The conditions for setting grace periods have been added in the following cases:
- Withdrawal of a marketing authorisation or a parallel trade permit achieved more than one year after the date of the active substance renewal for a marketing authorisation renewal dossier not fulfilled within the deadlines or abandoned by the company (Case n°2b).
- Withdrawal or amendment of a marketing authorisation following a scientific assessment, in particular after the instruction of a marketing authorisation renewal application (Case n°3).
- Withdrawal or amendment of a marketing authorisation for a resale product or withdrawal of a parallel trade permit following a scientific assessment of the reference product or identical product authorised in France (Case n°3).
ANSES note – Grace periods granted by ANSES and deadlines to update labels in case of withdrawal, amendment or non-renewal of a marketing authorisation or a parallel trade permit for plant protection products – Updated version of 27.04.2021 (in French)
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