(Art. 14 para. 2 let. b)
Application for simplified authorisation
1With the application for simplified authorisation, evidence must be provided to the Notification Authority that the conditions for the simplified procedure specified in Article 11h are met.
2In addition to the information specified in paragraph 1, the dossiers for the biocidal product must contain the following details:
- name and address of the applicant;
- name and address of the manufacturer of the biocidal product and the active substances;
- trade name of the biocidal product;
- full composition of the biocidal product;
- a summary of the biocidal product characteristics in accordance with Article 20 paragraph 1 letter a point ii of Regulation (EU) No 528/20121;
- efficacy data;
- justified proposals for classification and labelling, as well as information concerning the packaging as specified in Articles 35, 36 and 38;
- if necessary, proposal for the safety data sheet in accordance with Article 40.
3The Notification Authority may ask the applicant to provide the following additional documents:
- assessment reports from EU or EFTA authorities concerning the product and the active substances, if such reports are available and accessible to the applicant;
- samples of packaging, drafts for labelling and for leaflets, as well as a draft label.