Simplified authorisations

Make sure that you have everything you need before making your application.

  • The Biocides Submission Manual (BSM) 'Technical Guide: How to prepare a biocides dossier'.
  • The Biocides Submission Manual (BSM) 'Technical Guide: How to use the SPC Editor’.
  • The Biocides Submission Manual (BSM) ‘Application instructions: How to submit an application for Simplified Authorisation'.
  • The "Supporting Documents" table from ECHA's website. Make sure that you use the latest document template.
  • The ‘Guidance The Practical Guides.

Submit your application

 

Authorisation of biocidal products
  • Prepare your IUCLID dossier.
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘SA-APP – National authorisation - simplified procedure'. The application ‘wizard' will guide you through the various steps of the submission process.

 

Authorisation of the same biocidal product (pending and authorised)
  • Create your SPC file from the authorised SPC of the reference family case or asset, using specific functionality in the SPC Editor – Apply for a same product.
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘SA-BBP – Simplified authorisation of the same biocidal product (pending)' and enter the reference number (the simplified authorisation case number of the reference biocidal product) or ‘SA-BBS – Simplified authorisation of the same biocidal product (authorised)' and enter the reference number (the simplified authorisation asset number of the reference biocidal product) to launch the application ‘wizard' which will guide you through the various steps of the submission process.
  • If you want to submit a batch of administrative change(s) (i.e: SA-ADC), click on the ‘NEW APPLICATION’ tab on the R4BP 3 toolbar, and select ‘Administrative changes’ at the bottom of the page to launch the application wizard.

 

Administrative change on request
  • Draft your SPC file from the authorised SPC of the reference asset.
  • Log into R4BP 3.
  • From the ‘ASSETS' tab, search for the relevant simplified authorisation asset for which you wish to request a change. Launch your application by clicking ‘Create new case' for ‘SA-ADC - Simplified authorisation administrative change on request'. The application ‘wizard' will guide you through the various steps of the submission process.
  • If you want to submit a batch of administrative change(s) (i.e: SA-ADC), click on the ‘NEW APPLICATION’ tab on the R4BP 3 toolbar, and select ‘Administrative changes’ at the bottom of the page to launch the application wizard.

 

Minor and major change on request
  • Prepare your IUCLID dossier..
  • Draft your SPC file from the authorised SPC of the reference asset.
  • Log into R4BP 3.
  • From the ‘ASSETS' tab, search for the relevant simplified authorisation asset for which you wish to request a change. Launch your application by clicking ‘Create new case' for ‘SA-MIC - Simplified authorisation minor change on request' or ‘SA-MAC - Simplified authorisation major change on request'. The application ‘wizard' will guide you through the various steps of the submission process.

 

Transfer of authorisation
  • The owner of a simplified authorisation asset must first initiate a transferral in R4BP 3; this is done in the ‘Delegation/Nomination' tab of the asset. Once the owner has delegated the asset, you can start the acceptance.
  • Draft your SPC file from the authorised SPC of the obtainable asset.
  • Log into R4BP 3.
  • From the ‘ASSET' tab, search for the relevant simplified authorisation asset. Locate the specific asset labelled with a ‘T’ (for ‘transfer’) and click on the asset number and from the details page click ‘Accept Asset Transfer’. The application ‘wizard' will guide you through the various steps of the process.

 

Notification for a product in a product family
  • Create your SPC file from the authorised SPC of the reference family asset, using specific functionality in the SPC Editor – ‘Notify a product’.
  • Log into R4BP 3.
  • From the ‘ASSETS' tab, search for the relevant simplified authorisation asset. Launch your application by clicking ‘Create new case' for ‘SA-NPF - Notification of product in product family for simplified authorisation'. The application ‘wizard' will guide you through the various steps of the submission process.

 

Notification of unexpected or adverse effect
  • Log into R4BP 3.
  • From the ‘ASSETS' tab, search for the relevant simplified authorisation asset. Launch your application by clicking ‘Create new case' for ‘SE-NOT - Notification of unexpected or adverse effect for simplified authorisation'. The application ‘wizard' will guide you through the various steps of the submission process.

 

Notification for placing on the market
  • Log into R4BP 3.
  • From the ‘ASSETS' tab, search for the relevant simplified authorisation asset. Launch your application by clicking ‘Create new case' for ‘SN-NOT - Notification for placing on the market'. The application ‘wizard' will guide you through the various steps of the submission process.
  • If you want to submit a batch of notifications, click on the ‘NEW APPLICATION’ tab on the R4BP 3 toolbar, and select ‘Notification(s) to place on the market products holding simplified authorisations’ at the bottom of the page to launch the application wizard.

 

Administrative change of notification for placing on the market
  • Draft your SPC file from the authorised SPC of the reference asset.
  • Log into R4BP 3.
  • From the ‘ASSETS’ tab, search for the relevant asset of notification for placing on the market. Clicking on the asset number hyperlink in the ‘Assets list’ will open a details page for that specific asset. On this page, click ‘Create new case’ and a list of application types available for that asset will appear. From this list, you can launch the wizard by selecting ‘SN-ADC – Administrative change of notification for placing on the market’. The application ‘wizard’ will guide you through the various steps of the submission process.

 

Cancellation of notification for placing on the market
  • Log into R4BP 3.
  • From the ‘ASSETS’ tab, search for the relevant asset of notification for placing on the market. Clicking on the asset number hyperlink in the ‘Assets list’ will open a details page for that specific asset. On this page, click ‘Create new case’ and a list of application types available for that asset will appear. From this list, you can launch the wizard by selecting ‘SN-CCL – Cancellation of notification for placing on the market’. The application ‘wizard’ will guide you through the various steps of the submission process.

Follow up your applications

  • Important – make a note of your submission number. You will need it for further reference.
  • Important - check your tasks and messages in R4BP 3 regularly. They can include:
    • Requests for more information. These are important because if you fail to complete the task by the deadline, your application may be rejected.
    • Invoices, which have a 30-day deadline for payment. If you fail to pay the fee within the deadline, you application will be rejected.
    • Results of the ECHA format check.
    • Results of the acceptance step.

Withdraw your application

If you don’t want to proceed with one of your application, you are allowed to withdraw it from the system:

  • Search for your case
  • In the case details page, click on ‘withdraw case’
  • Confirm the case withdrawal

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