National authorisation - administrative change on request

There are two types of administrative changes: those requiring prior notification before implementation and those which can be notified after implementation. 

The Changes Regulation (Regulation (EU) No 354/2013) sets out the procedure to notify an administrative change for a product authorisation. The grouping of changes is also possible in certain circumstances. Accordingly, a single application for an administrative change may cover:

  • a series of proposed administrative changes affecting the same product, or 
  • a series of proposed administrative changes affecting different products in the same manner.
If an intended change is not listed in one of the tables in the Annex to the Changes Regulation, or if the authorisation holder is unable to determine the category to which their intended change belongs, they may request ECHA to issue an opinion on the classification of the change. A separate application for an opinion must be submitted for each change sought.
 
Refer to ECHA's Biocidal Products Regulation pages and to the legislation, in particular Regulation (EU) No 354/2013, for more information.

 

Preparing a notification

  • Refer to the supporting documents table for submission requirements. Use the available document templates where appropriate.
  • All the necessary information will be submitted through R4BP 3. Follow the instructions in the Biocides Submission Manuals: BSM 2 ‘Using R4BP 3 for biocide applications' and BSM 4 ‘Biocidal products - Part B: National authorisation changes on request'.

Submission through R4BP 3

  • Sign up for REACH-IT. Refer to BSM 2 ‘Using R4BP 3 for biocides applications' for instructions.  
  • Log into R4BP 3 with your User ID and password defined in REACH-IT. Refer to BSM 4 ‘Biocidal products - Part B: National authorisation changes on request'. Access your asset for national authorisation in R4BP 3 and create a new case for a ‘National authorisation administrative change on request'. The submission wizard will guide you through the submission process.

If your asset is not visible in R4BP 3 it may be that the relevant national authorisation has not yet been migrated from R4BP 2 to R4BP 3. In this case, please refer to the ‘Migration' Q&A section on the ECHA website or contact the ECHA helpdesk for further advice on how to proceed with your application.

Follow up in R4BP 3

Regularly check your messages and tasks in R4BP 3. You will find various types of messages under the ‘MESSAGES' tab in R4BP 3, for example:

  • Result of the format check 
  • Result of the acceptance step

You may also receive authority requests for more information through R4BP 3 with a deadline. The requests will appear under TASKS. If you fail to meet the deadline, your application may be rejected.

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