To avoid duplication of the evaluation procedure, the product authorisation granted in one MS can be recognised in other MS through the mutual recognition procedure. Therefore, if a company wishes to place the product on the market in several countries, it can apply for national authorisation in one member state and for mutual recognition in the others.
Applications for mutual recognitions can be made either in parallel to the application in the reference member state (RMS) or in sequence to the authorisation in the RMS.
Mutual recognition in sequence
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.
Mutual recognition in parallel
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.
Alternatively, in case companies wish to place their product on the market in a large number of European countries, they companies apply for a Union authorisation. A union authorisation allows companies to place their product on the market throughout the entire European Union. More information about Union authorisations can be found here (link maken).
National applications in combination with mutual recognition(s) can be made for both single products and for biocidal product families.
Further information on the mutual recognition in relation to other application types can be found in ECHA’s Practical Guide on BPR – Mutual recognition.