There are four procedures to get your medicinal product authorized in Europe: National, Decentralized, Mutual Recognition, or Centralized. Bronsing prepares, plans, and executes Marketing Authorization Applications on your behalf.
Bronsing Life Science Consultancy:
- prepares your dossier according to the requirements
- organizes its compilation
- applies for a pre-submission meeting, if needed
- applies for the actual procedure
- guides you through the MAA procedure
- coordinates answering of questions that are raised
- helps mitigate risks
What are the different routes to MAA?
The National Procedure provides a Marketing Authorization (MA) in a single country. This MA can then serve as the basis for a fast, 90 days, procedure, known as the mutual recognition procedure.
The Mutual Recognition procedure is where other countries, which you select, accept or object to your MA in the Reference Member State.
With the Decentralized Procedure, you select one Member State, the Reference Member State (RMS), to take the lead in assessing your product. The RMS reports its findings in an assessment report, which the other Member States comment on. After 210 days, excluding clock stops, the procedure is over, and the MA is either granted or denied.
The Centralized Procedure is a procedure with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The CHMP appoints a rapporteur and a co-rapporteur who, together, assess your dossier, ask questions and make an assessment report. The CHMP, consisting of members from all Member States of the European Union + Iceland and Norway, then vote on the product and issue an opinion. If positive, the European Commission in almost all cases grants an MA in all EU Member States + Iceland and Norway.
What if the Member States do not reach a consensus in MRP or DCP?
With both the Decentralized- and the Mutual Recognition Procedure, it may be possible to go for a referral to the CHMP if there is no consensus between member states.