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Identical product PDF Print E-mail
Written by DPR Biocides - Anses   

Regulations: Regulation ( EU) No 414/2013

Comments

Identical products are products with the same properties. The reference product must have a national MA (or be undergoing assessment) in order to apply for the same biocidal product.

Timeframe

Validity of the MA

Expiry date identical to that of the reference MA.

Fees payable to ANSES

For each application for an identical product: 800 euros

Composition of the dossier

Documents to be submitted on R4BP

Language

Draft SPC (xml format) – for BBP

EN

Draft RCP (xml format) – for BBS

FR

Supporting document (see ECHA website): “supporting document for the application for national authorisation of the same biocidal product”

FR or EN

Letter of access for active substances

FR or EN

Product formulation FR or EN

Certificate from applicant pdf which confirms that the product is identical to the reference product excepted for possible administrative changes

FR

List of all trade names included in each meta-SPC of the product family – only for family

FR

Letter of access for the original reference product if holders are different – if necessary

FR or EN

Letter of access for the related product, if holders are different – in case of same on same for example

FR or EN

‘Permission to refer’ decision granted by ECHA – if necessary

FR or EN

ECHA decision concerning technical equivalence – if necessary

FR or EN

Last Updated on Friday, 10 March 2017 16:33