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Written by DPR Biocides - Anses
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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
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Documents to be submitted on R4BP
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Language
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Draft SPC (xml format) – for BBP
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EN
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Draft RCP (xml format) – for BBS
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FR
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Supporting document (see ECHA website): “supporting document for the application for national authorisation of the same biocidal product”
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FR or EN
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Letter of access for active substances
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FR or EN
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| Product formulation |
FR or EN |
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Certificate from applicant  which confirms that the product is identical to the reference product excepted for possible administrative changes
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FR
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List of all trade names included in each meta-SPC of the product family – only for family
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FR
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Letter of access for the original reference product if holders are different – if necessary
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FR or EN
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Letter of access for the related product, if holders are different – in case of same on same for example
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FR or EN
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‘Permission to refer’ decision granted by ECHA – if necessary
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FR or EN
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ECHA decision concerning technical equivalence – if necessary
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FR or EN
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Last Updated on Wednesday, 18 July 2018 13:26 |
