Procedure for companies wishing to apply for a biocidal product authorisation for the Danish market.
Processing of an application requires that the applicant provides documentation and pays a fee. In addition, the applicant will typically have to pay for access to data to the company which has been granted approval of the active substance.
When Denmark is the initial country of application (the reference Member State), the application must include the following:
- Use of R4BP-3 to process your application
- The application submitted must include the original studies of efficacy and the so-called maximum residue limits (MRL) as well as safety data sheets for co-formulants. See Guide to efficacy studies
- A letter of access if the applicant himself is unable to provide all the information required in the dossier.
- A summary of the biocidal product characteristics (SPC). This document plays a major role in the processing of the application.
- A statement that the applicant has not applied to any other authority for a national authorisation for the same biocidal product.
ECHA has published a manual in which you will be guided through the application process. Read the manual here
A template for a national authorisation is available; Template: Product Assessment Report (PAR) National Authorisation (May 2016)
Furthermore, ECHA has prepared a guidance document on information requirements to be met by the applicant. Read the guidance document
Book a meeting with the Danish EPA
In the experience og the Danish EPA, a meeting between the applicant and authority in the planning phase of the application is a constructive way of addressing potential technical og practical problems. Hence the Danish EPA offers to meet with companies that are considering Denmark as rapporteur member state (a national application under the BPR), or plan to submit a dossier for a new active substance and are considering Denmark as evaluating authority. Contact to hear more about the possibility of a meeting.