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MUTUAL RECOGNITION IN SEQUENCE

Mutual recognition in sequence

MUTUAL RECOGNITION IN SEQUENCE

Sequential mutual recognition of a national authorisation for a biocidal product is a procedure under which an applicant applies for an authorisation for a biocidal product in one or more Member States once the authorisation for this biocidal product has been granted in one Member State in accordance with Article 17 of Regulation (EU) no. 528/2012.

LEGAL BASIS
Article 33 of Regulation(EU) no. 528/2012 concerning the making available on the market and use of biocidal products

REQUIRED DOCUMENTS
– An application written in Slovenian and submitted through R4BP 3;
–Translation of the national authorisation of the reference Member State into Slovenian or English;
– Summary of Product Characteristics (SPC) in Slovenian;
– Proposal for labelling the biocidal product in Slovenian;
– Safety data sheet for the biocidal product in Slovenian;
– Proof of fee payment.

TAXES
After receipt of an application, the Office shall inform the applicant of the amount and method of payment of the fee and the deadline for such. Taxes are determined under point 3 of the Annex to the Decree implementing Regulations (EU) concerning the making available on the market and use of biocidal products ((Ur. l. RS [Official Gazette of the Republic of Slovenia], no. 20/2014).
The tax for a single biocidal product amounts to EUR 2,500 and/or for a biocidal product family to EUR 3,700.

Taxes shall be paid to the following suspense account of the Chemicals Office of the Republic of Slovenia: (IBAN No.): SI5601100-8450080537 (SWIFT code: BSLJSI2X, Bank name: The Bank of Slovenia (Banka Slovenije), Slovenska cesta 35, Ljubljana, SLOVENIA), the purpose of the payment (convocation/reference): name of the biocidal product.

For the procedure performed by the European Chemicals Agency (ECHA) in connection with the application for mutual recognition of the authorisation, other amounts of taxes shall be charged, namely in the amount of EUR 700, in accordance with Annex III to Commission Implementing Regulation (EU) no. 564/2013. Payments shall be made only after the ECHA has issued an invoice.

AMENDMENT OF THE AUTHORISATION
The authorisation may be amended on the basis of Articles 47 through 50, Chapter IX of Regulation (EU) no. 528/2012 and in accordance with Commission Implementing Regulation (EU) no. 354/2013 on changes of biocidal products. Taxes are determined under point 3 of the Annex to the Decree implementing Regulations (EU) concerning the making available on the market and use of biocidal products ((Ur. l. RS [Official Gazette of the Republic of Slovenia], no. 20/2014).

RENEWAL OF AUTHORISATION
An application for renewal of authorisation shall be submitted in accordance with Article 31 of Regulation (EU) no. 528/2012 at least 550 days prior to the expiry of the validity of the authorisation. Taxes are determined under point 3 of the Annex to the Decree implementing Regulations (EU) concerning the making available on the market and use of biocidal products ((Ur. l. RS [Official Gazette of the Republic of Slovenia], no. 20/2014).

ADDITIONAL INFORMATION
Additional information is available on the ECHA and European Commission websites.
Any further questions can be submitted to the website of the Chemicals Office of the Republic of Slovenia biocidi.mz(at)gov.si or to the ECHA.