National 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) ‘Application instructions: National authorisations'.
  • 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

 

Important note for national authorisation renewal submissions

When you apply for a national authorisation renewal (NA-RNL) please make sure that you attach the correct supporting document. The supporting document to use depends on whether you are renewing:

  • a single authorisation or;
  • two or more authorisations linked by mutual recognition.

When you submit a renewal for two or more national authorisations, make sure that you identify each and every asset and enter them in only one supporting document. The supporting document needs to include all assets that form part of the same group for each and every application.

When you prepare a renewal for two or more national authorisations linked by mutual recognition, it is vital that you organise amongst the asset owners which assets will be renewed and the distribution of the submission work.

Please contact the ECHA Helpdesk or your national helpdesk if you have any queries concerning your application for a national authorisation renewal.

Submit your applications

 

Authorisation of biocidal products
  • Prepare your IUCLID dossier. Refer to the instructions in the Biocides Submission Manual (BSM) 'Technical Guide: Using IUCLID'.
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Technical Guide: Using R4BP 3' and in the ‘ECHA Accounts Manual for industry users'.
  • From the ‘NEW APPLICATION' tab, select ‘NA-APP – Application for national authorisation' to launch the application ‘wizard', which will guide you through the various steps of the submission process.
  • You can apply for more than one Mutual recognition(s) in parallel at the same time. You can submit simultaneous applications to every concerned Member State by making a selection in the relevant tick boxes in the ‘Select authorities’ step. You can also initiate the Mutual recognition(s) in parallel at a later stage. Please refer to the specific section below for further information.

 

Mutual recognition in parallel
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Technical Guide: Using R4BP 3' and in the ‘ECHA Accounts Manual for industry users'.
  • You can launch your application in three different ways:
    • During the submission of an application for national authorisation, in the ‘Select authorities' step, as explained in the section above.
    • From the ‘NEW APPLICATION' tab: select ‘NA-MRP – Mutual recognition in parallel' and enter the reference number (the national authorisation case number of the biocidal product you want to have recognised in parallel).
    • From the ‘CASES' tab: search for the relevant national authorisation case you want to have recognised in parallel. Click on the case number and from the details page launch your application by clicking ‘Create new case' for ‘NA-MRP – Mutual recognition in parallel'.
  • The application ‘wizard' will guide you through the various steps of the different submission processes.

 

Mutual recognition in sequence
  • Log into R4BP 3. The instructions are in the Biocides Submission Manual (BSM) ‘Technical Guide: Using R4BP 3' and in the ‘ECHA Accounts Manual for industry users'.
  • You can launch your application in two different ways:
    • From the ‘NEW APPLICATION' tab; select ‘NA-MRS – Mutual recognition in sequence' and enter the reference number (the national authorisation asset number of the biocidal product you want to have mutually recognised).
    • From the ‘ASSETS' tab, search for the relevant national authorisation asset you want to have mutually recognised. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘NA-MRS – Mutual recognition in sequence'.
  • The application ‘wizard' will guide you through the various steps of the different submission processes.

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