Brexit is a done deal, as the HMA website’s Brexit Page reminds us:
“A transition period, during which EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ continued to be applicable to the UK, has ended on 31 December 2020.”
But it sounds like some organizations have yet to put their houses in order. HMA recently issued an update to Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP. A new FAQ reminds sponsors about the consequences of submitting an MAA that relies on registration elements in the UK. Presumably, this was added because they are receiving applications that do not comply with the rules.
38. What will happen if I submit a marketing authorization application after the end of the transition period with the applicant, future MAH, batch release site, batch control site, local representative, QPPV and/or PSMF located in the UK?
They also address another twist: what to do when a generic product relates to a reference product from the UK:
39. How do I keep the product information of my generic/hybrid updated if the reference product in the initial MA application was from the UK?
A review is probably in order for organizations that have experienced change, perhaps due to mergers, acquisitions, or changes to their portfolios or marketing plans. To summarize: EEA will not allow marketed products if the following entities are in the UK:
- MAH
- QPPV & PSMF
- Batch release site
- Batch control site
- Notified Body for co-packaged devices
In-progress MRP/DCP applications cannot have an applicant or Reference Medicinal Product in the UK. Finally, 126a applications (exemptions for justified public health reasons) cannot reference a UK authorization.
Reflecting on your organization’s Brexit response likely mirrors your RIM preparedness. There were a series of questions triggered by Brexit which are perfectly suited for RIM answers.
Marketing Authorisations
- Which approved MAAs have the UK as the RMS?
- Of those approved MAAs, which ones have MAHs in the UK? (Necessitating a change in MAH.)
- For an application with multiple strengths, which countries have approved the most strengths? (Because the guidance asks for the “smallest possible number of new RMS countries.”)
- Which MAAs that are not yet approved reference an Applicant in the UK? When will those applications hit the Day 106/160 (for DCP) or Day 40 (for MRP) milestones?
- Are there any planned 126a applications referencing a UK authorization?
- Which approved or in-progress generic/hybrid MAAs have a Reference Medicinal Product only approved in the UK?
Manufacturing Sites
- Which UK sites are performing batch release/batch quality control for approved products?
- Which UK sites are acting as an authorized importer?
- Which UK sites perform intermediate processing (as opposed to finished product processing) and will now be considered an import?
- Which UK sites are performing finished product manufacturing?
Pharmacovigilance
- Which QPPVs for approved products are in the UK? Of those, which have MAHs in the EEA? (If the MAH is in the EEA, it requires a notification only change of QPPV.
Even if your organization is not affected, Brexit provides an interesting exercise to see if your RIM system can answer these questions. Some points to consider:
- How much time and effort do you estimate would be needed to obtain these answers?
- What manual processes would be involved?
- What information would you need from departments other than Regulatory?
- What information are you not tracking in RIM that would be needed to obtain these answers? Should you start tracking it in the future?
Closing the books on Brexit provides an opportunity to validate your approach to regulatory information management as well as to ensure that you haven’t missed anything in remaining compliant.