(Art. 14 para. 2 let. c and 14a )
1The following documents must be submitted together with the application for recognition of an authorisation: a. for recognition of an authorisation granted by an EU or EFTA Member State: 1. a copy of the authorisation granted by the EU or EFTA Member State, 2. assessment reports from EU or EFTA authorities concerning the authorisation of the biocidal product, if they are accessible to the applicant, 3. a letter of access for the active substances contained in the biocidal product; b. for recognition of a Union authorisation: 1. a summary of the biocidal product characteristics in accordance with Article 20 paragraph 1 letter a point ii of Regulation (EU) No 528/20121, 2. a letter of access for the active substances contained in the biocidal product, 3. assessment reports from EU or EFTA authorities or the ECHA opinion concerning the authorisation of the biocidal product, if they are accessible to the applicant.
2The following documents must be submitted together with the application for recognition in parallel in accordance with Article 34 of Regulation (EU) No 528/2012:
3In addition to the documents specified in paragraph 2, the following documents must be submitted directly upon receipt:
4The Notification Authority may request from the applicant, for the biocidal product and the active substances contained therein, the documents specified in Annexes II, III and IV to Regulation (EU) No 528/2012.
See footnote to Art. 1b para. 3. ↩
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