13.07.2015 Views

LAW ON BIOCIDAL PRODUCTS

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Against the Decision from Paragraph 1 of this Article an appeal may be lodged to theMinisterDecision from Paragraph 4 of this Article shall be final and administrative procedureagainst it may be initiated.6. Temporarily permitArticle 30In the case of unforeseen danger which cannot be suppressed by other means or bybiocidal products for which the Decision on inclusion of the biocidal product into theTemporary List or authorisation was issued, temporarily permit may be issued for placing ofthe biocidal product on the market (hereinafter: temporarily permit).Temporarily permit may also be issued for the new manner and conditions of use ofthe biocidal product for which the Decision on inclusion of the biocidal product into theTemporary List or the authorisation was issued.Manufacturer or importer of the biocidal product shall submit to the Agency theapplication for the temporarily permit (hereinafter: the applicant for the temporarily permit)Application referred to in paragraph 1 of this Article may be submitted by foreignproducer through his representative, i.e. representation office established on the territory of theRepublic of Serbia.Where the applicant is the representative i.e. representation office, the evidence shallbe submitted along with the application.Upon the request of the Agency, the applicant for the temporarily permit shall submitsamples of the biocidal product and its components.Article 31Along with the application for the temporarily permit, the applicant shall be requiredto submit evidence on: unpredicted presence of harmful organism, justification ofunavailability of biocidal product on the market which can suppress harmful organism, data onefficacy of the biocidal product, quantities needed, persons that will use the biocidal productas well as proposal for systematic monitoring of use of that biocidal product.The Agency shall, on the basis of the evaluation of the data referred to in Paragraph 1of this Article, issue the temporarily permit within 30 days from the day of submitting of thecomplete application.Conditions for limited and controlled use shall be established in the temporarily permitas follows: quantities, the date when the use starts, area of use, manner of use, method ofsystematic monitoring, users and period of use.Period of validity of the temporarily permit shall not exceed 120 days.Period of validity of temporarily permit may be extended only in the case when, evenafter the expiry of 120 days, harmful organisms were not sufficiently suppressed.The fee shall be charged for the evaluation of the data referred to in Paragraph 1 of thisArticle.14

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