Sequential mutual recognition
The Member State in which the application is first submitted (the evaluating Member State) conducts the primary assessment and provides a Product Assessment Report. Based on the authorisation and the underlying assessment, you can then request mutual recognition in other Member States. This short procedure (30 days validation + 90 days evaluation) is called the ‘sequential mutual recognition’.
Parallel mutual recognition
It is also possible to submit applications for primary assessment and mutual recognition simultaneously. When submitting the application in the evaluating Member State, you indicate the countries in which you want to request mutual recognition. In addition an application for mutual recognition in parallel is submitted to all of those member states. The evaluating Member State will then consult with these other Member States about the assessment and the conditions for authorisation. With this ‘parallel mutual recognition’, the authorisation enters into force simultaneously in all Member States concerned.
Mutual recognition in parallel and national authorisation reflect two possible roles of a competent authority in a single process, i.e. assessment of an application fora national product authorisation by the ‘Reference Member State’ with in parallel consultation of ‘concerned Member States’. As a result RMS and CMS authorise the product at the same time. The flow chart below represents the activities related to an application for mutual recognition in parallel with the activities related to the national authorisation in grey.
Once a national authorisation under the BPR has been granted in one Member State (the ‘Reference Member State’), mutual recognition in sequence can be applied for in other Member State(s). The flowsheet below represents the activities related to an application for mutual recognition in sequence.
If agreement on product characteristics (SPC and PAR) cannot be reached, the disagreement may be referred to the Coordination Group (BPR art 35). Details about this procedure can be found in S-CIRCABC.