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Written by DPR Biocides - Anses
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These are defined in Article 3-1-a-aa) of Regulation ( EU) No 528/2012. Some must be notified prior to their implementation (e.g. product name, transfer of the authorisation to another holder, etc.) and others may be notified no later than one year after their implementation (e.g. certain amendments to the conditions of use, classification and labelling, etc.).
Regulations: Chapter II, Article 6 of Regulation (EU) No 354/2013
Timeframe
Validity of the MA
- Expiry date identical to that of the reference MA.
- No new MA number is issued.
Fees payable to ANSES
For all types of administrative changes: 800 euros per application
Composition of the dossier
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Documents to be submitted on R4BP
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Language
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Draft RCP (xml format)
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FR
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Supporting document (see ECHA website) “Notification for an administrative change of a national/simplified authorisation”
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FR or EN
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Opinion issued by ECHA regarding the classification of the application – if necessary
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EN
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Cross-certificate of acceptance of the product transfer – in case of transfer of the authorisation
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FR
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Extract from the Commercial Register or any other official document showing the change in holder name – in case of change in the name or address of the authorisation holder
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FR
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LoA updated for AS and/or reference product – in case of transfer of the authorisation , or change in the name or address of the authorisation holder
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FR or EN
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New LoA for active substance – in case of addition or modification of AS manufacturer
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FR or EN
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Last Updated on Wednesday, 06 July 2016 18:12 |
is available.