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Fra:Understanding BPR - ECHA
As in the previous directive, the approval of active substances takes place at Union level and the subsequent authorisation of the biocidal products at Member State level. This authorisation can be extended to other Member States by mutual recognition. However, the new regulation also provides applicants with the possibility of a new type of authorisation at Union level (Union authorisation).
Fra Softox Q4.
After hearing the Norwegian and Danish regulatory authorities, a final approval for
Scandinavia is expected late March, after which approval in each EU market can be pursued
on the local, country specific level. …
We can now prepare for mutual
approval processes and launches in several European markets.
Mulig godkjennelsen kan overføres direkte gjennom “mutual authorisation”, og at man da slipper å gjennomgå ny runde i valgte land. Men usikker.
Mutual recognition
If a company wishes to extend the national product authorisation to other markets, it can ask other Member States to recognise it. Companies can apply for mutual recognition either in sequence or in parallel.
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.
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.
In both cases, 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 Stetes 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.