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.

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] 14 November 2023
AA-TRS List of active substances and suppliers Supporting document for applications for transfer of Article 95 assets [DOC] 14 November 2023
AS-APP Amendment to the conditions of an approved active substance Amendment to the conditions of active substance approval [DOC] 14 November 2023

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] 14 November 2023
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] 14 November 2023
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] 14 November 2023
NA-APP National authorisation of biocidal products Supporting document for national authorisation application [DOCX] 14 November 2023
UP-APP Pre-submission phase for Union authorisation Pre-submission phase for Union authorisation [DOCX] 14 November 2023
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] 14 November 2023
NA-APP
UA-APP
Provisional authorisation (National and Union) Application for provisional authorisation  [DOC] 14 November 2023
NA-APP
UA-APP

NA-BBP
UA-BBP

Application for national authorisation
Application for Union authorisation

Application for national or Union authorisation of a same biocidal product (pending)

List of existing_new products for NA_UA processes [XLSX] 22 January 2024
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] 14 November 2023
NA-BBP
NA-BBS
SA-BBP
SA-BBS
Application for national or simplified authorisation of a same biocidal product  Application for national or simplified authorisation of a same biocidal product [DOC] 22 January 2024
UA-BBP
UA-BBS
Application for Union authorisation of a same biocidal product Application for Union authorisation of a same biocidal product [DOCX] 22 January 2024
NA-ADC Administrative change on request (national authorisation) Notification for an administrative change of a national authorisation  [DOCX] 14 November 2023
UA-ADC Notification of an administrative change to a Union authorisation Notification of an administrative change to a Union authorisation [DOCX] 22 January 2024
SA-ADC Notification of an administrative change to a simplified authorisation Notification of an administrative change to a simplified authorisation [DOCX] 22 January 2024
NA-MIC Application for a minor change of a national authorisation Application for a minor change of a national authorisation [DOC] 14 November 2023
UA-MIC Application for a minor change of a union authorisation Application for a minor change of a union authorisation  [DOC] 14 November 2023
SA-MIC Application for a minor change of a simplified authorisation Application for a minor change of a simplified authorisation [DOC] 14 November 2023
NA-MAC
 
Application for a major change of a national authorisation   Application for a major change of a national authorisation  [DOCX] 14 November 2023
UA-MAC Application for a major change of a union authorisation Application for a major change of a union authorisation [DOCX] 14 November 2023
SA-MAC Application for a major change of a simplified authorisation Application for a major change of a simplified authorisation [DOCX] 14 November 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]

14 November 2023
NA-RNL Renewal of a single national authorisation under Article 31 of BPR

Renewal of single national authorisation  [DOCX]

14 November 2023
TE-APP Assessment of technical equivalence, Tiers I and II Technical equivalence [DOCX] 14 November 2023
TE-APP Assessment of technical equivalence, Tier II Report template Tier II assessment [DOCX] 14 November 2023
N/A List of active substances and suppliers Requests for corrections of entries on the Article 95 list [DOC] 14 November 2023
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]
9 December 2021