Application for mutual recognition in sequence in Denmark
If a company wishes to extend a national product authorisation to other markets, they can ask other Member States to recognise it.
To apply for mutual recognition in sequence, companies first need to have their product authorised in one Member State (called the reference Member State, rMS) thereafter, they can request other Member States to recognise this authorisation.
The application for mutual recognition in sequence in Denmark shall include the following information:
- The national authorisation granted by the initial country of application (rMS), in Danish or English.
- A summary of the biocidal product characteristics (SPC) from the initial country of application.
- A draft SPC for use in the Danish authorisation (in English). The instruction for use in the SPC should be detailed and preferable in Danish. Download the template for the SPC.
- Letter(s) of Access/Authorisation (LoA) from the manufacturer of the active substance and to other data if relevant.
- A safety data sheet for every co-formulant (in accordance to REACH regulation)
- Original studies for the efficacy of the product. See Guide to efficacy studies
- A two years storage stability test and an accelerated storage stability test.
- The product assessment report (PAR) from the initial country of application.
- Study summaries for the product (doc. IIIB) with the evaluation of the studies by the initial country of application.
Submit applications via R4BP 3
Applications are submitted via R4BP 3. The mutual recognition process will take approximately five months from the validation of the application by the evaluating competent authority.
If a concerned Member State do not agree to mutual recognition, the case will be referred to the Coordination Group, which has 60 days to seek agreement. The Coordination Group is a body formed by representatives of the Member States and the Commission.
If the Coordination Group cannot reach an agreement, the matter is referred to the Commission which may ask ECHA for an opinion on the scientific or technical aspects of the case.
ECHA has published a manual to guide you through the application process