The European Medicines Agency has issued its first set of questions and answers about the impact of Brexit on companies based in the United Kingdom. In most instances, if the U.K. ceases to be a member of the European Economic Area (EEA) on 20 March 2019, then:
- UK companies will need to operate through companies located within the EEA;
- Pharmacovigilance and product release will have to be performed by companies within the EEA;
- Active ingredients, bulk drug substances and final drug products which are manufactured in the U.K. will be treated as imports with regard to provision within the European Union;
- Small and medium sized enterprises (SME) will only be eligible for EMA SME Benefits if they operate through an SME within the EEA and both U.K. and EEA entities meet the definition of an SME.
Although these Q&A reflect the current legislation, the actual outcome will all depend on the final settlement terms agreed by EU and U.K. governments. If an existing or new structure can be utilised to keep the UK under the EEA umbrella, then many of these potential barriers will disappear. As any arrangements are likely to be reciprocal, affecting pharmaceutical companies based inside and outside the EEA, negotiations may lead to a greater concensus than is apparent at the start.
Queen’s House Consulting is based in U.K. and will continue to offer its services to clients inside and outside the EU. Please contact Queen’s House Consulting to discuss your particular needs.
To read the EMA Q&A, click here.
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