Renewal of a biocidal product

Written by DPR Biocides - Anses

Regulations: Chapter VI, Article 31 of Regulation ( EU) No 528/2012

Timeframe

Between 7 and 16 months depending on whether or not the competent assessment authority decides that the product assessment must be exhaustive.

Validity of the MA: 10 years

Fees payable to ANSES

Composition of the dossier

Initially, written agreement should be sought from the competent authority chosen for the assessment work. This document should be submitted to ECHA.

Documents to be submitted on R4BP	Language
Draft SPC (xml format)	EN
Draft RCP (xml format)	FR
Completed technical IUCLID dossier. In section 13: Assessment of whether the conclusions of the previous assessment are still valid LoA and/or data on active substances Product MSDS in French MSDS of each ingredient Label / draft label in French (and instructions for use in French, if appropriate) ‘Permission to refer’ decision granted by ECHA – if necessary ECHA decision concerning technical equivalence – if necessary	FR or EN
Table of intended uses in Word format	FR or EN
Detailed composition form in Excel or Word format	FR or EN
Written confirmation from the evaluating RMS stating their agreement to evaluate the application
List of all trade names included in each meta-SPC of the product family – only for family	FR
Supporting document (see ECHA website): “Renewal of single national authorisation”	FR or EN

Last Updated on Thursday, 07 July 2016 15:52