- Dossier Submission Tools
- R4BP 3
- National authorisation - administrative change on request
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.
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.