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NATIONAL AUTHORISATION

NATIONAL AUTHORISATION

 

National authorisation is an administrative act by which the competent authority of a Member State authorises the making available on the market and the use of a biocidal product or a biocidal product family in its territory or in a part thereof.

LEGAL BASIS

Article 29 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 throughR4BP 3;
- The dossier in an IUCLID format for the biocidal product and active substances in the English language (requirements under Annexes II and III of the BPR) or a Letter of Access (LoA);
- Summary of Product Characterisation (SPC) in the Slovenian and English languages;
- Proposal for labelling the biocidal product in Slovenian;
- Safety data sheet for the biocidal product in Slovenian;
- Proof of fee payment (the Office shall specifically inform you on the amount of the fee and the deadline of its payment).
We recommend that future applicants contact the Office at least one year prior to the submission of their application.

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 laid down under points 2 and 3 of the Annex to 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. 20/14).

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.

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 the Commission Implementing Regulation (EU) no. 354/2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 (OJ L 109 of 19 April 2013). Taxes are laid down under points 2 and 3 of the Annex to 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. 20/14).

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 laid down under points 2 and 3 of the Annex to 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. 20/14).

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 ECHA.