Some of the biggest process changes involve the marketing authorization (MA) application. For example, where they don’t already have presence, it will become necessary to set up a marketing authorization holder (MAH) in the EU or European Economic Area (EEA), a legal requirement. Furthermore, the MA dossier must be assessed by a Reference Member State (RMS) that is not UK, which means in future the UK’s health authority, the MHRA, will not be able to evaluate an application for EU or EEA markets, nor act as an RMS or concerned member state (CMS). The UK will in essence be a “third-country” with a significant loss in EU procedural licence influences for pharma and medical device products.
Some of the other implications that are as a result of Brexit are outlined below:
- MHRA – Loss of MHRA expertise that could be detrimental for scientific approval for the EU as the MHRA led 20% of scientific evaluations of new medicines in the EMA.
- Potential Delays for UK Patients – countries such as Switzerland that possess a bilateral agreement with EU have a delay of approximately 157 days later than EU countries.
As a result of Brexit there are many other logistical challenges to work through, such as regulatory labeling, package inserts, and leaflets.
Multi-country packs, for example, will generally not be feasible in the UK after Brexit. Multi-country packs are those that are labeled in such a way as to allow them to be placed on the markets of more than one EU member state. However, after Brexit, the MAHs that use multi-country packs that include the UK will have to adapt their packaging to remove the UK. Multi-country packs remain valid in the UK if the product information is the same in the UK as in the EU member states and meets other criteria laid out by European directives.
The impact of Brexit extends to the naming of local representatives in the product information, since these individuals must be based in the EU or EEA. If the representative was UK-based in the past, amendments must be completed and implemented before Brexit.
The MHRA is striving to ease the process for companies as much as possible. The agency is expected to give companies another year after Brexit goes into effect to amend packaging and leaflets for products already on the UK market. Furthermore, the MHRA is open to allowing English-language information on the packaging and leaflets from other markets, such as Ireland, so long as the information complies with the UK’s requirements.
The MHRA is also seeking to reduce the workload on companies by announcing that the UK will continue to accept batch testing carried out in certain countries on the whitelist – EU and EEA countries as well as those with which the EU have an agreement. The same approach will be applied to the certification by a Qualified Person (QP) responsible for ensuring the batch meets compliance requirements before releasing the batches. However, for products manufactured in a third country and directly imported into the UK, companies will need to ensure a UK-based QP certifies batch testing and that there is full compliance with good manufacturing practice guidelines.
Despite these steps to limit the work companies face with Brexit, there are several key changes, particularly with regards to pharmacovigilance and quality oversight of products. After Brexit, companies will no longer be able to have their EU Qualified Person for Pharmacovigilance (QPPV) in the UK. Additionally, assuming a no-deal situation, they will be required to have an equivalent UK QPPV for UK authorized products, and that person will be responsible for establishing and maintaining the UK pharmacovigilance system master file.
While negotiations between the UK and EU on a withdrawal plan continue, life sciences companies should prepare for the worst-case scenario – a hard Brexit. Having plans in place will help to ensure continuity of operations and smooth relations between UK and EU-based manufacturers and MAHs. Above all, the focus must remain on the patient – ensuring continued supply of medicines and meeting the health needs of the UK population.
Generic marketing authorizations granted before 30 March 2019 that are based on the reference product in UK will remain valid. Furthermore, bioequivalence studies with UK reference product may only be used in generic applications if an MA is granted before the above date.
Our expert team at Celegence provide comprehensive regulatory services for the life sciences industry and can help you navigate current and future labeling challenges as they relate to the aftermath of Brexit. Make sure you and your business are Brexit ready and get in touch today.