Brexit: Implications on Existing Marketing Authorisations
One year on from the UK’s decision to leave the European Union the negotiations have begun. The life sciences sector is, perhaps, one of the sectors that will be most impacted by the result of the referendum and many companies are setting plans in place to deal with a new regulatory landscape. What are the implications on existing marketing authorisations?
In the past year we have published a number of very well received whitepapers and thought leadership articles on the issue of Brexit. Our work has been acknowledged by major media organisations such as Politico and a wide range of niche publications and websites. Now that the negotiations have begun, I think that it is an appropriate time to revisit a handful of the most widely read and quoted pieces from the last twelve months. We are regarded as the industry leaders on the subject and, consequently, we are working with a large number of pharmaceutical and medical device companies on their Brexit related issues.
What does this mean for existing marketing authorisations (MA’s)? The European procedures; Mutual Recognition Procedure and Decentralised Procedures (commonly known as MRP and DCP Procedures) have been extensively used over the years. Note: The difference between MRP and DCP is that a product must already be authorised in at least one Member State on a national basis in order for MRP to be used. It was first introduced in 1998. DCP may be used if the product is not already authorised in any Member State, but does not want to use the centralised procedure, or the product is not eligible for the centralised procedure.
Under the MRP and the DCP the MHRA has been used extensively as RMS since these procedures were first introduced. It is estimated that the MHRA has acted as RMS for a significant number of procedures since they were first introduced. On the following page we have outlined the percentages of cases that they have assisted with from 2006 to 2016 and in the first six months of 2017.
One of the proposed Member States will be asked by the applicant company to act as Reference Member State (RMS). The RMS undertakes the initial evaluation of the product and issues a draft assessment report. The other Member States, known as the Concerned Member States (CMS), either agrees with the RMS’s evaluation or they ask further questions/raise objections. The DCP was first introduced in 2004 following the enactment of Dir 2004/27/EC.
Where the MAH wants to change RMS, it must first contact the intended RMS and discuss the company’s intention to switch RMS the MAH must first contact the intended RMS and discuss the company’s plans to switch RMS. If they are willing to take on the role as RMS, one must then request a new DCP number. Some of the National Competent Authorities (NCA’s) have established an application form and a fee structure for this process. Once agreement has been reached with the proposed RMS indicating their willingness to act as the reference member state, the MAH must contact the MHRA and notify them of their intention to change RMS. It is incumbent on the MHRA to send the Assessment Report (AR) to the intended RMS. We know that there is no new assessment of the assessment report by the new RMS. It is only the public assessment report that needs to be sent to the new RMS. There is no timeline for this
At this time, the UK can be retained as a CMS, and the UK licence number will remain the same, until further information becomes available to us. It is expected that all open applications; such as the renewals and variations must be concluded by the current RMS prior to the transition. Will the MHRA take the permitted three months to update the AR? Also, will the MAH receive a copy of the AR or will this be an automatic process?
The availability of resources at the new RMS will dictate how soon they can assume the new RMS. We can support you with this transfer process and ensure the product lifecycle remains unaffected in all territories.
While we are managing the transfer process of changing the RMS from the UK to a new member state, we, as regulatory professionals, must also be mindful of planned regulatory strategies. We have noted that some National Competent Authorities (NCA’s) are already at capacity and are not in a position to act as RMS for new regulatory procedures for a period of at least 12 months. It could be difficult to secure scientific advice meetings in a timely manner, so we might need to adjust our strategies and be prepared for a slow down in procedural start times.
We can assist you with issues relating to your Marketing Authorisations that might be impacted by the UK’s decision to leave the EU. Contact us on 00353 52 61 76 706 or complete the form below.