Authorisation for identical biocidal products

Authorisation for identical biocidal products is issued for products that are identical to another biocidal product or family of products for which the authorisation has been issued.

The application in Slovenian should be submitted through the R4BP 3 system of the European Chemicals Agency.

The application for the issue of the authorisation for the same biocidal product must contain the following information:

  •  authorisation number of the related reference product (or if the approval has not been issued yet, the number of the application of the related reference product in the register of biocidal products);
  • statement of proposed differences between the same product and the related reference product and evidence that the products are identical in all other aspects;
  • statement of the availability of all data on the basis of which the approval has been issued for the related reference product;
  • draft of the summary of suitable characteristics of the biocidal product;
  • draft summary of the characteristics of the biocidal product for the same product; suitable labelling - proposed label, and a safety data sheet.
     

Upon the receipt of the application, the competent authority notifies the applicant on the amount, method and deadline for payment of the fee. The fee is determined in item 3 of the Annex to the Decree implementing Regulations (EU) concerning availability in the market and use of biocidal products and amounts EUR 400 for a biocidal product or EUR 800 for a family of products.

Legal protection

  • Judicial remedy: Appeal
  • Competent authority: European Chemicals Agency (ECHA)

Other activities

Last updated: 10 years

Responsible: Ministry of Health | Last updated: 10. 02. 2016