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Informative Notice

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Permit for parallel trade

A parallel trade permit shall be issued (in Slovenia, Member State of introduction) for a biocidal product authorized in another Member State (Member State of origin) if that biocidal product is identical to a product already authorized in Slovenia (reference product).

Identity requirements:

  • both products were manufactured by the same company or an associated company or produced under license in accordance with the same production process;
  • they are identical in specification and content in terms of active substances and in the type of formulation;
  • they are the same in terms of the content of inactive substances;
  • they are identical or equivalent in terms of size, material or shape of the packaging in terms of possible adverse effects on the safety of the product in terms of human health, animal health or the environment.

An applicant who intends to place a biocidal product on the market in Slovenia shall submit an application for a permit for parallel trade to the Chemicals Office of the Republic of Slovenia.

The application must be submitted through R4BP 3 of the European Chemicals Agency (ECHA). It must contain the following information:

  • the name and authorization number of the biocidal product in the Member State of origin;
  • the name and address of the competent authority of the Member State of origin;
  • name and address of the applicant;
  • the trade name given to the biocidal product in the Member State of introduction;
  • the name and authorization number of the reference product in the Member State;
  • a sample of the biocidal product if the competent authority deems it necessary.

In order to be authorized, a biocidal product must meet the requirements for appropriate labelling and have a safety data sheet.

The authorization shall be subject to the payment of a fee in accordance with point 2.2 of the Annex to the Regulation implementing the Regulations (EU) on the making available on the market and use of biocidal products.

Conditions

These terms apply to activity Market availability and use of biocidal products

Renewal term

Renewal term: 10 years