150 Days to the End of the Transition Period: A Focus on Centrally Authorised Products
Today marks 150 days until the end of the UK-EU transition period; on the 1st January 2021 the UK will no longer be in the EU single market and customs union.
Following on from our post about the possible UK eCTD publishing requirements in a post-Brexit world, our next regulatory topic is the anticipated post-transitional arrangements of medicinal products approved via the centrally authorised procedure in the European Union.
Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing-authorisation application to EMA. This allows the marketing-authorisation holder (MAH) to market the medicine throughout the EU on the basis of a single marketing authorisation. It is worth noting that most novel medicines and biosimilars (as well as some generics), come to market via the centralised authorisation procedure.
As the deadline for the British government to seek an extension to the transition period has now expired, there is a drive from the EMA and European competent authorities to ensure that pharma and medical devices companies have completed their Brexit preparations by the end of 2020, but whilst the post-transitional arrangements between the EU and UK are far from agreed, this is easier said than done!
The only course of action open at this moment for EU based pharma companies that market medicines in the UK is to prepare for the worst-case scenario. This is where the transition period ends without any trade agreement and no specific arrangements such as mutual recognition agreements between the EU and UK are in place.
In the absence of any alternative guidance, it can be assumed that on the 1st January 2021 all centrally authorised products (CAP) will automatically be converted into national marketing authorisations in the UK (through a process known as ‘grandfathering’).
This means that EU based MAHs with CAPs potentially have a number of regulatory actions that will need to be performed following the end of the transition period (timetables for these actions yet to be confirmed by the MHRA):
- For grandfathered CAP marketing authorisations with a non-UK MAH, change of ownership applications to be submitted to the MHRA, as a MAH will need to be established in the UK. It is worth noting that following the end of the transition period, if an MAH is not established in the UK, companies will be expected to appoint a UK-based contact person.
- MAHs will need to provide the MHRA with baseline data for CAPs that are converted into UK marketing authorisations.
- All UK MAs require a UK pharmacovigilance system master file (PSMF) and a qualified person responsible for pharmacovigilance (QPPV) residing and operating in the UK.
- Updates to the pharmacovigilance system to accommodate these changes will typically need to be submitted via a Type IAIN – C.I.8.a variation, which means submission must be within 14 days of the implementation of the change.
- In order to register a UK PSMF, a unique UK PSMF number must be requested from the MHRA for each pharmacovigilance system that is being operated for UK authorised products.
There is of course a myriad of other considerations for pharma companies.
Here at Jenson R+, like many companies we are trying to adapt to the ever-changing guidance and speculation. To complement our regulatory expertise, we have marketing authorisation holding, PV and batch release capabilities on both sides of the Brexit divide, so can provide the bespoke solution you are looking for in the new regulatory landscape.