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.

 

Authorisation of the same biocidal product (pending and authorised)
  • 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-BBP – National authorisation of the same biocidal product (pending)' and enter the reference number (the national authorisation or mutual recognition in parallel case number of the reference biocidal product) or ‘NA-BBS – National authorisation of the same biocidal product (authorised)' and enter the reference number (the national authorisation asset number of the reference biocidal product) to launch the application ‘wizard'.
  • The application ‘wizard' will guide you through the various steps of the submission process.

 

Renewal of authorisation(s) (including authorisations subject to mutual recognition)

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 ‘ASSETS' tab, search for the relevant national authorisation asset you wish to renew. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘NA-RNL - Application for renewal of national authorisation'. The application ‘wizard' will guide you through the various steps of the submission process.
 
If you want to initiate the renewal of a single national authorisation(s) under Article 31 of the BPR, your receiving Member State is already given and you should leave the other asset(s) proposed in the ‘Grouping of assets' step (if any) unselected. Submit your application with the supporting document ‘Renewal of a single national authorisation'.
 
If you want to initiate the grouped renewal of several national authorisation(s) linked by mutual recognition under Article 2 of Regulation (EU) No 492/2014, you should:

  1. List all the assets to be renewed together in the supporting document ‘Grouped renewal of several authorisations linked by mutual recognition' that should be attached to your submission,
  2. Among the assets you have access to, select one which has been granted by the Member State you have chosen as reference Member State for the renewal and initiate the renewal from this asset;
    N.B.: in case you do not have access to any asset granted by the selected reference Member State, select any other asset and initiate the renewal from this asset,
  3. Select all the appropriate asset(s) by ticking the corresponding boxes in the ‘Grouping of assets' step; by doing this, simultaneous applications will be sent to the Member States corresponding to the selected assets,
  4. If you are not able to select all the assets listed in the supporting document (i.e. the assets which should be renewed together), the assets not covered by your submission will have to be covered by other (additional) submission(s) which should all contain the same supporting document in order to ensure the linking,
    N.B.: the additional submission(s) can be made either by you or by other companies, depending on who has access to the assets to be renewed which have not been covered by your submission.

If you want to include a new NA-RNL case in your grouped renewal of several national authorisations, you should search for your reference case. The status should be ‘in progress’ or ‘suspended’. Click on ‘create new case’ in the submission details page to launch the application wizard.

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