Brexit - The UK will no longer be a Reference Member State (RMS)
What is a Reference Member State (RMS)?
According to the Heads of Medicines Agency, “The Reference Member State (RMS) is the Member State, which evaluates the marketing authorisation application dossier and prepares the assessment report on behalf of the Concerned Member States in Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP).
RMS has an essential role in both Mutual Recognition and Decentralised procedures; the RMS acts as a scientific assessor of the documentation, as a regulatory advisor to the applicant, and as a moderator in the discussion between the applicant and the Concerned Member States (CMS).”
Given that the UK is the Reference Member State (RMS) for approximately 3400 EU procedures, it is essential that regulators develop a solid action plan to assist the RMS transition.
Below are the new applications (started and finalised) from January 1st to June 30th this year as reported by the CMDh
Choosing a new RMS
Having previous experiences with an HA can be of great benefit. These networks often ensure that procedures move along accordingly. Due to their experience with that RMS these professional bodies watch out for and mitigate unforeseen delays.
Differences in Health Authorities
Each member state is responsible for their own day to day business and operations. Some might be better communicators than others. It is highly recommended that companies check the processing times and see if there’s a backlog of a possible new RMS. It is also necessary that they contact the Health Authority to check their availability to take over as RMS for existing procedures.
Another thing worth checking is which of the current Member States are actively preparing for Brexit. The more prepared countries will most likely be the better performing.
RMS has experience in a Therapeutic Area
I relation to certain therapeutic areas, certain RMS may have more experience than others. In the event that you have a generic, it is recommended to check the originator’s RMS. This can often be the RMS for other generics.
You need to ask yourself the following questions:
- Does a Health Authority have a special focus regarding specific therapeutic areas?
- Have they been involved in the development of certain guidelines?
Location of the Company
It is advisable to avoid language barriers where possible. Having the right infrastructure in place is of high importance.
You should choose your RMS according to your company’s EU affiliates. This can increase the possibility of direct communication with the HA. T
There are several commercial reasons to interact with a certain RMS:
- straight-forward aspects like fees charged by HA's
- the market size of the RMS
- are there key opinion leaders available?
Practicalities and Recommendations
Keep in mind:
- there cannot be a change of RMS during an ongoing procedure (of importance for timing/planning)
- it’s the obligation of the MAH to ensure that both the current RMS and the future RMS accept the change of RMS
- it’s the responsibility of the MAH to provide any dossier or assessment reports, or other relevant materials missing, or for any reason not already in possession of the new RMS to the new RMS
- you should map your company’s situation and set up timelines for changes
- your budgets need to be adapted to higher (or lower) costs. HAs charge different fees for different procedures
- you should thoroughly investigate possible RMS
- to help prevent any unforeseen delays or problems you should contact your HA of choosing well in advance
- Don’t forget that these changes are imminent. They will most likely cause a backlog on popular HA’s. As a result, proper research and planning are well-advised.
Below you’ll find all possible member states that can be chosen as an RMS. There are differences in the amount and type of applications each state has handled in the past.
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