1.The applicant for an authorisation shall submit the following documents together with the application:
(a)for biocidal products other than biocidal products meeting the conditions laid down in Article 25:
(i)a dossier or letter of access for the biocidal product satisfying the requirements set out in Annex III;
(ii)a summary of the biocidal product characteristics including the information referred to in points (a), (b) and (e) to (q) of Article 22(2), as applicable;
(iii)a dossier or a letter of access for the biocidal product satisfying the requirements set out in Annex II for each active substance in the biocidal product;
[F1the competent authority may refuse to accept a letter of access for the purposes of this Article if it does not hold the relevant data.]
(b)for biocidal products that the applicant considers meet the conditions laid down in Article 25:
a summary of the biocidal product characteristics as referred to in point (a)(ii) of this paragraph;
efficacy data; and
any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25.
[F22.Applications must be submitted in English.]
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Textual Amendments
F1Words in Art. 20(1) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 81(a); 2020 c. 1, Sch. 5 para. 1(1)