Documentation requirements mutual recognition
Extensive requirements apply concerning documentation, both when you apply for approval of an active substance within the EU and when you apply for authorisation of a product through the Danish Environmental Protection Agency.
Authorisation of a biocidal product is based on an applicant submitting all necessary documentation to demonstrate that the product concerned has no unacceptable effects on either human health or the environment and that it is effective. This documen-tation typically consists of test data. The Danish Environmental Protection Agency carries out its own evaluation of the risk to the environment and health, whilst the efficacy of the product is evaluated by external consultation partners such as the Danish Pest Infestation Laboratory.
Documentation requirements vary depending on whether you are applying for authorisation in Denmark as the country of initial application in the EU or whether you are applying for mutual recognition.
Below are listed the document types that must be enclosed if apply for mutual recognition in order for the Danish Environmental Protection Agency to accept the application.
Form and content requirements for the documentation are given at the bottom of the page.
Mutual recognition in Denmark
When the reference Member State is not Denmark, but an applicant wishes to apply for mutual recognition in Denmark, the following information must be submitted to the Danish Environmental Protection Agency for the initial stage, in other words upon inclusion of the active substance in Annex I:
- Notification that an application for authorisation has been filed in a specified Member State and that an application will be filed for mutual recognition in Denmark (by means of R4BP)
- A signed print-out from R4BP
- A copy of the “summary dossier” submitted to the country of initial application (reference Member State). The Danish Environmental Protection Agency may ask for this to be translated into English.
For the second stage, the following must be submitted to the Danish Environmental Protection Agency within two months of initial authorisation in the country of initial application:
- A copy of the authorisation granted by the reference Member State and a translation thereof into Danish or English.
- A product assessment report produced by the reference Member State.
- A copy of the applicant’s summary dossier with the evaluation of the studies by the reference Member State (completed evaluation forms for each study) – in English.
- Updated Danish user instructions and a proposed Danish label in accordance with the initial authorisation, plus safety datasheets for co-formulants
- The Danish Environmental Protection Agency may furthermore request the full original documentation (i.e. document IV from the full dossier) as submitted to the country of initial application. This should be available in English.
Requirements concerning form and content of the documentation
Form and data requirements for the dossier for submission
Here, you will find information on the test requirements, stipulations on the scope of the dossier, and access to the guidelines prepared by the EU.
Other requirements for biocidal products
All biocidal products must meet a raft of requirements. There are for example requirements concerning the label, marketing, classification, registration requirement for the product register, etc.