Applications for same biocidal products (NA-BBP) Reference product Annex II dossier or LoA (from company A) Annex III dossier or LoA Reference's product dossier (Article 20(1) of the BPR) The data sharing agreement in the LoA should indicate the right to sub-license the access to the complete active substance dossier to affiliates, customers, or consortium members Application for PA (company B) Application for PA (company C) Time SBP application dossier (Article 2(c) of the SBP Regulation) LoA to Annex II (from company B) LoA to Annex III (from company B) As the data sharing agreement for the LoA granted by company A for the reference product is recent, this would not pose any problem to company B to issue the LoA needed for the SBP application by affiliates, customers, or consortium members (company C) Same biocidal product: case type NA-BBP

Applications for same biocidal products (NA-BBS) Product authorisation* (company B) Reference product *Note: even if the LoA from company A is revoqued, the PA remains valid (Article 61(2) BPR) Source AS-1 (LoA) Source AS-2 (TE + Art. 95) SPC Source AS-1 (LoA) Source AS-2 (TE + Art. 95) SPC or Source AS-1 (LoA) - SPC Admin. change Time Which LoA to Annex II? LoA to Annex III dossier SBP application dossier (Article 2(c) of the SBP Regulation) Application for PA (company C) Over time several scenarios might occur: Source AS-1 linked to the LoA from company A is no longer relevant in the reference product Others… Same biocidal product: case type NA-BBS

Applications for same biocidal products (NA-BBS) Reference product *Note: even if the LoA from company A is revoqued, the PA remains valid (Article 61(2) BPR) SPC SPC Product authorisation* (company B) SPC Admin. change Source AS-1 (LoA) Source AS-1 (LoA) Source AS-1 (LoA) or Source AS-2 (TE + Art. 95) Source AS-2 (TE + Art. 95) - Time SBP application dossier (Article 2(c) of the SBP Regulation) Article 2(c) of the SBP Reg.: "LoAs to all the data supporting the authorisation of the reference product" Open question: at which stage? the date of authorisation of the reference product? at the time of the submission of the application for the SBP? Which LoA to Annex II? Application for PA (company C) LoA to Annex III dossier Note: a new LoA from company A to the Annex II dossier is no longer required for the renewal of the authorisation of the reference product by company B Same biocidal product: case type NA-BBS

Applications for same biocidal products (NA-BBS)  Proposed way forward for case type NA-BBS only: - Where the source linked to the LoA (from company A) supporting the initial authorisation of the reference product (granted to company B) is no longer relevant in the authorisation of the reference product (i.e. removed from the SPC), company B may grant LoAs to all the data supporting the authorisation of the related reference product (LoA to alternative dossier(s) of the source(s)* in the SPC + LoA to the Annex III dossier) at the time of the submission of an application for a same product by company C. - No assessment of the alternative source in the SPC of the reference product shall take place during the processing of the SBP application * Provided that company B is the alternative supplier listed in Art. 95 or has the right to refer a LoA from the alternative supplier listed in Art. 95

 Applications for same biocidal products (NA-BBS) SBP identical to reference product  Reference product *Note: even if the LoA from company A is revoqued, the PA remains valid (Article 61(2) BPR) SPC SPC Product authorisation* (company B) SPC Admin. change Source AS-1 (LoA) Source AS-1 (LoA) Source AS-1 (LoA) or Source AS-2 (TE + Art. 95) Source AS-2 (TE + Art. 95) - Time SPC Source AS-1 (LoA) SBP authorisation (company C) Source AS-2 (TE + Art. 95) Same biocidal product: case type NA-BBS