Brexit: What To Do If Your RMS Is In the UK
Historically, Reference Member States (RMS) have rarely been changed, as there has been no need to do so. Brexit has changed all of that and now many companies are having to change their RMS because of the UK’s decision to leave the EU.
Typically, the Marketing Authorisation Holder (MAH) can request a change of RMS only under exceptional circumstances, one of these being of course Brexit; All companies that have a marketed product for which the RMS for a Mutual Recognition Procedure (MRP) or Decentralised Procedure (DCP) is currently the UK will have to change their RMS to inside the EU.
So just a quick summary of an RMS’ role. They act as:
- scientific assessor of a dossier
- regulatory advisor to the applicant
- moderator between applicant and CMS
The RMS provides regulatory and scientific advice as well as assessment reports, they decide on timetables, evaluate responses, organize and chair break-out sessions, refer to the CMDh, inform the EMA if there is no consensus after referral, inform applicant and Concerned Member State (CMS) after positive conclusion and prepare the final assessment report as well as the public assessment report.
It’s clear there is ample motivation to do some research on the different Health Authorities (HA).
Below are a few things to consider when choosing a new RMS:
Know Your RMS
Previous experiences with an HA can be of major advantage. These connections often make sure procedures move along according to the set timetables without any unforeseen trouble because you understand their point of view, they speak the same language so to speak. These professionals look out for and mitigate unforeseen delays due to their experience with that Reference Member State; they are familiar with their workload, approach and the way they communicate.
Differences Among Health Authorities
Although we’re all in the EU, every member state is responsible for their own day-to-day business. Some might be better communicators, others more prone to act in a timely matter and others more inclined to be open to more pragmatic approaches. Companies are especially recommended to check the pass-through times and a backlog of a possible new RMS and are required to contact the Health Authority in advance to check their availability to take over as Reference Member State for existing procedures. Besides there is also a difference in not every HA has extensive experience acting as an Reference Member State at all.
RMS Has Experience In A Therapeutic Area
Some RMS have more experience than others in certain therapeutic areas. Are you a generic, you might want to check the originator’s RMS; which is often also the RMS for other generics. This is noticeable when an originator product goes off-patent because almost all generics manufacturers will tend to apply with this same RMS with which the original was registered. Or does a Health Authority have a special focus regarding specific therapeutic areas? Have they been involved in the development of certain guidelines? If the new RMS is going to be one of the current CMS, recall what the attitude towards the product was during a previous application. These are all questions worthwhile to investigate before making a final decision.
Location Of The Company
Though it might seem like an open door, avoiding language barriers and having the proper infrastructure in place is always a benefit to the daily business. It’s also strategic to choose your RMS according to your company’s EU affiliates; opening up the possibility of direct communication with the HA. Increased contact and the ease of face-to-face counsel can contribute positively. This is especially useful considering we’re working in a regulatory universe that seems to thrive mainly on communication through elaborate documents. Besides these advantages, it also allows affiliates to join the strategic conversation with HQ and to increase their visibility and experience.
Last but not least: financial gain. There are several commercial reasons to interact with a certain RMS; straight-forward aspects like fees charged by HAs, the market size of the RMS and are there key opinion leaders available?
Some practicalities to keep in mind:
- there can be no change of RMS during an ongoing procedure (of importance for timing/planning);
- it is the obligation of the MAH to ensure that both the current RMS and the future RMS accept the change of RMS;
- it is the responsibility of the MAH to supply to the new RMS if any dossier/ assessment reports or other relevant materials are missing or for any reason not already in possession of the new RMS.
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