Administrative change

Written by DPR Biocides - Anses

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

30 days after payment of the required fees
An explanatory diagram of the procedure is available.

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

Documents to be submitted on R4BP	Language
Draft RCP (xml format)	FR
Supporting document (see ECHA website) “Notification for an administrative change of a national/simplified authorisation”	FR or EN
Opinion issued by ECHA regarding the classification of the application – if necessary	EN
Cross-certificate of acceptance of the product transfer – in case of transfer of the authorisation	FR
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	FR
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	FR or EN
New LoA for active substance – in case of addition or modification of AS manufacturer	FR or EN

Last Updated on Wednesday, 06 July 2016 18:12

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