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Written by DPR Biocides - Anses   

Once an approval decision has been made for all of a product's active substances for the product type ( PT) concerned, the product leaves the "transitional" regime and must obtain a marketing authorisation as provided for in Chapters VI and VII of Regulation ( EU) No 528/2012.

An industrial company already placing a biocidal product on the market and wishing to keep it on the market while the dossier is being assessed must submit the corresponding authorisation application dossier no later than around two years after the approval at European level of the last active substance contained in the product, in order to allow time for the industrials to compile their dossiers.

It is therefore up to industrials to carefully follow the review programme, in order to prepare for the deadlines. If no dossier is submitted within the timeframes for the products on the market during the transitional period, these products will be withdrawn from the market (see Article 89 of the BPR).

A table summarising pdf the characteristics of the different current types of application is available. This document is for information purposes; only the regulatory texts are authentic.

 

NB: Non-payment or incompleteness of a dossier at the time of the acceptance or validation phase shall be grounds for the rejection of an MA application.

Last Updated on Thursday, 30 June 2016 15:46