LAW ON BIOCIDAL PRODUCTS

4. Recognition of the authorisation for placing on the market of biocidal product Issued bythe competent authority of the EU Member StateArticle 23The Agency may issue authorisation for a biocidal product containing active substanceincluded into the List I – List of active substances or List Ia – List of active substancecontained in low-risk biocidal product, on the basis of an act by which the competent authorityof the EU Member State authorises placing on the market of the biocidal product.For the purpose of issuing of the authorisation referred to in Paragraph 1 of thisArticle, summary of the Technical Dossier and verified copy of an act by which the competentauthority of the EU Member State authorises placing on the market of the biocidal product,with certified translation into Serbian, shall be presented along with the application.The Agency shall carry out assessment of the data given in the summary of theTechnical Dossier and determine whether the target organisms is not present in harmfulquantities, if the unacceptable tolerance or resistance of the target organisms to the biocidalproduct is demonstrated or if the circumstances of use of the biocidal product (climate orbreeding period of target organisms etc.) differ significantly from those in the Member Statewhere biocidal product was authorised.The Agency shall issue the authorisation if it determines that placing on the marketand use of the biocidal product, under the same conditions as in the Member State wherebiocidal product was authorised, presents acceptable risk to humans, animals and theenvironment.The Agency may issue the authorisation with changed conditions for placing on themarket and use of the biocidal product from those given in the act issued by the competentauthority of the EU Member State, so that conditions for issue of the authorisation laid downin Article 17 of this Law are satisfied.The Agency shall issue the authorisation from Paragraph 1 of this Article within 120days for the biocidal product, i.e. 60 days for the low-risk biocidal product, from the day ofsubmitting of the complete application.Verified copy referred to in Paragraph 2 of this Article shall not be older than sixmonths.Period of validity of the authorisation shall be the same as the period of validity of theact from Paragraph 1 of this Article.The fee shall be charged for carrying out assessment of the data from Paragraph 3.Against the Decision from Paragraphs 4 and 5 of this Article, an appeal may be lodgedto the Minister.Decision from Paragraph 9 of this Article shall be final and administrative procedureagainst it may be initiated.The Agency shall lay down the content of the summary of the Technical Dossier aswell as biocidal product types for which the application for recognition of the act fromParagraph 1 of this Article may be refused.10