Union authorisations

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

You will see what you need in these places:

  • 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) ‘Technical Guide: How to use R4BP 3'.
  • The Biocides Submission Manual (BSM) ‘Application instructions: How to submit an application for Union Authorisation'.
  • The "Supporting Documents" table from ECHA's website. Make sure that you use the latest document template.
  • The ‘Guidance on information requirements for Biocides'.
  • The Practical Guides.

Submit your application

 

Getting started – pre-submission
  • Prepare your SPC file.
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘UP-APP – Pre-submission for union authorisation' to launch the application ‘wizard', which will guide you through the submission process.

 

Union authorisation
  • Prepare your SPC file.
  • Prepare your IUCLID dossier.
  • Log into R4BP 3.
  • From the ‘ASSETS' tab, search for your pre-submission asset. Click on the asset number and, from the details page, launch your application by clicking ‘Create new case' for ‘UA-APP - Union authorisation'. The application ‘wizard' will guide you through the various steps of the submission process.
  • If you don't have a pre-submission asset, you can start your application from the ‘NEW APPLICATION' tab and select ‘UA-APP – Application for union authorisation' to launch the application ‘wizard' which will guide you through the various steps of the submission process.

    Important note: although the pre-submission is optional, you are strongly

 

Authorisation of the same biocidal product (pending)
  • Create your SPC file from the SPC of the reference case, using specific functionality in the SPC Editor – ‘Apply for a same product’.
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION' tab, select ‘UA-BBP – Union authorisation of the same biocidal product (pending)' and enter the reference number (the union authorisation case number of the reference biocidal product) to launch the application ‘wizard', which will guide you through the various steps of the submission process.

 

Union authorisation major 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 union authorisation asset for which you wish to request a change. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘UA-MAC – Union authorisation major change on request’. The application ‘wizard’ will guide you through the various steps of the submission process.

 

Notification of product in product family for Union authorisation
  • 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 family union authorisation asset for which you wish to notify a product. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘UA-NPF – Notification of product in product family for Union authorisation’. The application ‘wizard’ will guide you through the various steps of the submission process.

 

Notification of unexpected or adverse effect for Union authorisation
  • Log into R4BP 3.
  • From the ‘ASSETS’ tab, search for the relevant union authorisation asset for which you wish to notify unexpected or adverse effect. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘UE-NOT – Notification of unexpected or adverse effect for Union authorisation’. The application ‘wizard’ will guide you through the various steps of the submission process.

 

Union authorisation 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 union authorisation asset for which you wish to request a change. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘UA-ADC – Union authorisation administrative change on request’. The application ‘wizard’ will guide you through the various steps of the different submission processes.
  • If you want to submit a batch of administrative change(s) (i.e: UA-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.

 

Transfer of a Union authorisation
  • The owner of a union authorisation asset must first initiate a transfer process 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 ‘ASSETS’ tab, search for the relevant union authorisation asset that is to be transferred to you. 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 submission process.

 

Union authorisation minor 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 union authorisation asset for which you wish to request a change. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘UA-MIC – Union authorisation minor change on request’. The application ‘wizard’ will guide you through the various steps of the different submission processes.

 

Union authorisation of the same biocidal product (authorised)
  • Create your SPC file from the authorised SPC of the reference family asset, using specific functionality in the SPC Editor – Apply for a same product.
  • Log into R4BP 3.
  • From the ‘NEW APPLICATION’ tab, select ‘UA-BBS – Union authorisation of the same biocidal product (authorised)’ to launch the application ‘wizard’. You will be prompted to provide a reference ‘asset number’. It is important to note that when you are creating a UA-BBS single product starting from a family, it is mandatory to insert the asset of the member of the family as reference asset in the submission wizard. The application ‘wizard’ will guide you through the various steps of the different submission processes.

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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