Recognition of SME status
Article 6
1. Before submission of an application to the Agency for approval, renewal or inclusion in Annex I to Regulation (EU) No 528/2012 of an active substance or for Union authorisation of a biocidal product or biocidal product family, submitted in accordance with Articles 7(1), 13(1), 28(4), 43(1) or 45(1) of that Regulation respectively, containing a claim for SME reduction, the prospective applicant shall submit to the Agency the relevant elements proving entitlement to such reduction by virtue of the status of SME in the meaning of Recommendation 2003/361/EC. 2. In the case of an application for approval, renewal or inclusion of an active substance in Annex I to Regulation (EU) No 528/2012, the question shall be determined by reference to the active substance manufacturer that is represented by the prospective applicant. In case of an application for product authorisation or renewal of product authorisation, the question shall be determined by reference to the prospective authorisation holder. 3. The Agency shall publish a list of the relevant elements to be submitted in accordance with paragraph 1. 4. Within 45 days of receipt of all the relevant elements referred to in paragraph 1, the Agency shall decide what SME status, if any, can be recognised. 5. A recognition of an enterprise as an SME shall be valid for applications submitted under Regulation (EU) No 528/2012 for two years. 6. An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against a decision taken by the Agency under paragraph 4.