For mutual recognition in parallel, the company can submit an application for product authorisation in one Member State (called the reference Member State) and simultaneously ask other countries to recognise the authorisation as soon as it is granted.
To apply for mutual recognition in sequence, companies first need to get their product authorised in one Member State. After this, they can request other Member States to recognise this authorisation.
Read more about mutual recognition in sequence
How to obtain a mutual recognition in parallel in several EU Member States
As a first step, the applicant must submit an application for a national authorisation via the R4BP to the relevant authority of the first Member State who will process the application.
The application must be accompanied by a list of all other Member States where a parallel mutual recognition is sought.
At the same time the applicant must submit an application for parallel mutual recognition to the relevant authorities of all other Member States where an authorisation is sought. Here the applicant must specify the names of the Member State processing the national authorisation (The Reference Member State and of all other Member States where an authorisation is sought.
Upon receipt of the application, each relevant authority will charge a processing fee to be paid by the applicant within 30 days.
When the applicant has paid the fees, the Reference Member State may spend up to 1 year and 30 days processing the application for a national authorisation and will then inform the other Member States of the result of the evaluation. After that decisions on mutual recognition must be made within 120 days.
The application must include the following
In cases where the initial country of application (the reference Member State) is not Denmark, but where application for mutual recognition in parallel in Denmark is planned, the application must include the following:
- A summary of the biocidal product characteristics (SPC). Before authorisation can be granted though mutual recognition, the SPC must be translated to Danish. Please see the SPC translation instructions.
- A list of all the EU Member States where mutual recognition is sought with reference to Article 34 of the BPR
- The assessment report from the initial country of application.
- Original efficacy studies. See Guide to efficacy studies
- A safety data sheet for every co-formulant.
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 the concerned Member States 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.