Parallel trade permit
A parallel trade permit is issued (in Slovenia – the country of entry) for a biocidal product, for which the permit was issued in another Member State (Member State of origin) and this biocidal product is identical to the product that is already permitted in Slovenia (reference product).
The requirements for identicalness are:
- the products are produced by the same company, an associated company or they are produced using the same production procedure;
- they are identical by specification and content in relation to active substance and type of formulation;
- they are identical with regard to the content of non-active substances;
- they are identical or equal with regard to size, material or the form of packaging with regard to the potential unwanted effects as a result of the product’s safety on human health, animal health or the environment.
Applicants who intend to market the biocidal product in a Member State of entry must lodge an application for authorisation for parallel trading at the competent authority of the Member State of entry.
The application should be submitted through the R4BP 3 system of the European Chemicals Agency (ECHA). It must contain the following information:
- the name and number of the authorisation for the biocidal product in the Member State of origin;
- the name and address of the competent authority of the Member State of origin;
- the name and address of the applicant;
- the name that is given to the biocidal product for the sale in the Member State of entry;
- the name and number of authorisation for the reference product in the Member State;
- a sample of the biocidal product if the competent authority believes it is necessary.
For the issue of the authorisation, the biocidal product must fulfil the requirements with regard to appropriate labelling and must have a safety sheet.
A fee determined in item 3 of the Annex to the Decree Implementing Regulations (EU) concerning availability in the market and use of biocidal products must be paid.
Conditions and evidence
Acquisition of a permit
- Judicial remedy: Appeal
- Competent authority: European Chemicals Agency (ECHA)
Last updated: 10 years