The deadline for Brexit is nearing (December 31 2020) and the industry is anticipating some new regulatory rules and possible disruptions with exports and availability of products. This could have potential lasting effects as the healthcare industry continues to fight the Covid-19 Coronavirus. Availability of medicines continues to be a high priority and it’s essential that there remains a continuation of supply of products. The European Medicines Agency (EMA) had set guidelines for Marketing Authorization holders (MAHs) back in March that were supposed to help with the Brexit transition and ensure UK-registered products continue to flood the markets in Europe.
As Covid-19 continues to affect the markets, there hasn’t been formal concessions on the adjustments of deadlines. All the current guidelines for MAHs are applicable for all goods registered in the UK. Businesses will need to make sure they adhere to the requirements in place as soon as possible. The requirements include products produced and exported from UK to EU (they’ll require a license to import), new administration and logistical rules, different border and customs regulations, market authorization transference and pharmacovigilance operations from UK to EU.
Businesses can prepare by registering with authorities right away, submitting requests to the competent authorities. They’ll need to consider their regulatory strategies, marketing authorization and take a closer look at import requirements per country. Companies will also need to consider packaging variations and submissions to respective authorities. They must act now by setting up appropriate systems and processes on either side in both the UK and EU for uninterrupted distribution of goods.
As per European Pharmaceutical Review*, it is best to keep in mind these following points to avoid delays in supply during the Brexit transition period:
- Prioritize submit an application for change of location of EU product registration/authorization to a current member state – This is especially important if the registration was earlier in the UK
- Select a QPPV for UK and make sure there’s a system to report pharmacovigilance in the UK
- Have all the necessary checks done for possible issues with the supply-chain. Also make sure all the appropriate import licenses and specific required documents are maintained and in order.