Supporting documents

Supporting documents

Supporting documents

 

The table below provides a link to the key supporting document needed for each of the application types under the Biocidal Products Regulation. Additional documents are often needed but depend on the specific application type. Further information on this topic is comprehensively outlined in the relevant Biocides Submission Manual.

Other documents that may be required or relevant in your individual case

Documents that are required for compliance / to enable processing

Please confirm that you are using the latest version of the document template, otherwise your application may not be accepted.

Application code Process Supporting document Date of
publication
AA-ADC List of active substances and suppliers Supporting document for applications for administrative change of Article 95 asset [DOC] 05 May 2020
AA-TRS List of active substances and suppliers Supporting document for applications for transfer of Article 95 assets [DOC] 05 May 2020
AS-APP Amendment to the conditions of an approved active substance Amendment to the conditions of active substance approval [DOC] 03 December 2014

AS-APP
AS-RNL
AN-APP

Active substance approval
Renewal of an active substance approval
Annex I inclusion
Approval of new active substances (AS-APP)/ Renewal of approval of active substances (AS-RNL)/ Annex I inclusion (AN-APP)  [DOC] 18 February 2022
AS-ACC  Inclusion in the Article 95 (active substance suppliers) list Supporting document for applications for Article 95 inclusion (AS-ACC) with reference to a dossier for which all data protection periods have expired [DOC] 18 July 2022
CC-APP Classification of a change of a products Request to ECHA to provide an opinion on the classification of a change of a products  [DOC] 03 December 2014
RP-NOT Notification to take over the role of participant / inclusion of Active Substance in the Review Programme Notification to take over the role of participant or to include an active substance/product-type in the Review Programme  [DOC] 05 October 2016
NA-APP National authorisation of biocidal products Supporting document for national authorisation application [DOCX] 08 May 2023
UP-APP/UP-BBS Pre-submission phase for Union authorisation Pre-submission phase for Union authorisation [DOCX] 21 October 2016
UA-APP Union authorisation application for a single product Justification of the claim that the product is identical with (one of) the representative product(s)  [DOCX] 18 April 2018
NA-APP
UA-APP
Provisional authorisation (National and Union) Application for provisional authorisation  [DOC] 03 December 2014
NA-APP
UA-APP

NA-BBP
UA-BBP
Application for national authorisation
Application for Union authorisation

Authorisation of same biocidal product (pending) for national and Union authorisation
List of existing_new products for NA_UA processes [XLSX] 08 May 2023
NA-NPF, SA-NPF, UA-NPF Notification of a product in a biocidal product family Notification of a product in a biocidal product family [DOC] 22 May 2018
NA-BBP
NA-BBS
SA-BBP
SA-BBS
UA-BBP
UA-BBS
Authorisation of a same biocidal product (pending and authorised) (National, Union and simplified authorisation) Application for authorisation of the same biocidal product under Regulation (EU) No 414/2013 [DOC] 21 March 2017
NA-ADC Administrative change on request (national authorisation) Notification for an administrative change of a national authorisation  [DOCX] 08 May 2023
UA-ADC
SA-ADC
Administrative change on request (union/simplified authorisation) Notification for an administrative change of a union/simplified authorisation  [DOC] 23 May 2018
NA-MIC Notification for a minor change of a national authorisation Notification for a minor change of a national authorisation  [DOC] 23 May 2018
UA-MIC
SA-MIC
Notification for a minor change of a Union/simplified authorisation Notification for a minor change of a union/simplified authorisation  [DOC] 23 May 2018
NA-MAC
 
Notification for a major change of a national authorisation Notification for a major change of a national authorisation  [DOCX] 08 May 2023
UA-MAC
SA-MAC
Notification for a major change of a union/simplified authorisation Notification for a major change of a union/simplified authorisation  [DOCX] 08 May 2023
NA-RNL Grouped renewal of several authorisations subject to mutual recognition under Article 2 of Regulation (EU) No 492/2014

Grouped renewal of several authorisations subject to mutual recognition  [DOCX]

08 May 2023
NA-RNL Renewal of a single national authorisation under Article 31 of BPR

Renewal of single national authorisation  [DOCX]

08 May 2023
TE-APP Assessment of technical equivalence, Tiers I and II Technical equivalence [DOCX] 30 October 2019
TE-APP Assessment of technical equivalence, Tier II Report template Tier II assessment [DOCX] 18 October 2018
N/A List of active substances and suppliers Requests for corrections of entries on the Article 95 list [DOC] 05 May 2020
N/A Authorisation of biocidal products family Template overview of the biocidal product family [XLS]
Instructions for the template overview of the biocidal product family [PDF]
14 January 2022
N/A Additional information for invoicing Declaration [DOC] 9 December 2021