The European Commission and the European Medicines Agency (EMA) have recently published a questions and answers (Q&A) document addressing certain possible key consequences of Brexit for pharmaceuticals companies operating in the EU or EEA (full document available here).
The document provides a reminder of the need for businesses in the pharmaceuticals sector to evaluate any changes that may be necessary in respect of their marketing authorisations, or their operations more generally, in consequence of Brexit.
A number of key points are covered by the Q&A document. These are all subject to any transitional arrangements or final agreement reached between the UK and EU, which could potentially avoid some of the changes that may otherwise become necessary.
As a matter of EU law, all marketing authorisation holders must be established in the EU or EEA. Therefore, amongst other matters, the Commission and EMA address the possible need for existing marketing authorisations currently held by UK-based addressees to be transferred to entities located in another EU or EEA Member State prior to the UK’s withdrawal. Otherwise, in the absence of any transitional arrangements, those authorisations would lapse.
The Q&A document also details the following changes that might be required of pharmaceuticals companies operating in the UK:
- A qualified person responsible for pharmacovigilance (QPPV) must reside and carry out his/her tasks in the EU or EEA. A UK-based QPPV may therefore need to become resident in another Member State or the business might need to appoint a new, suitably qualified, individual who is resident elsewhere within the EU or EEA.
- Pharmacovigilance System Master Files (PSMF) for medicines for human use must also be located within the EU or EEA. Therefore, if the PSMF is currently held in the UK, it may be necessary to transfer it to another Member State. This may have an indirect impact on other pharmacovigilance and administrative functions.
- Active substances and medicinal products manufactured in the UK may, as of the date of the withdrawal of the UK from the EU, be considered to be imported substances/products. In order for UK-manufactured active substances for medicinal products to be imported into the EU or EEA they would then, amongst other requirements, need to be accompanied by written confirmation from a component authority that the standards of good manufacturing practice (GMP) and control of the facility manufacturing the relevant substance are equivalent to those applicable under EU law.
- In order for UK-manufactured medicinal products to be imported into the EU or EEA, EU/EEA competent authorities may need to ensure that the import is subject to an appropriate authorisation in accordance with Article 40(3) of Directive 2001/83/EC and Article 44(3) of Directive 2001/82/EC. This requires, for example, the presence of a qualified person within the EU or EEA and a GMP inspection.
- Marketing authorisation holders may need to transfer UK-based batch control and batch release functions to a site in the EU or EEA.
Since Brexit negotiations between the UK and EU remain at an early stage, it is unclear whether any transitional or final agreement will be put in place to avert the need for some or all of these actions. However, the guidance will be of interest to healthcare businesses that are currently engaged in contingency planning.
A number of the possible changes could take some time to implement (for instance, the transfer of marketing authorisations or the relocation or substitution of qualified persons), and there may not be clarity until relatively soon before the 29 March 2019 deadline for Britain’s withdrawal from the EU (assuming that there is no agreement to extend this).
Finally, it is also worth noting that the Q&A document only addresses the requirements that pharmaceuticals companies may have to meet if they are to continue marketing their products within the (post-Brexit) EU and EEA. While it remains possible that the UK could also adopt its own new requirements following its withdrawal from the EU, in the short-term it is likely that transitional arrangements will maintain the status quo, allowing EU marketing authorisation holders to continue to market their products in the UK.
The EMA intends to update the Q&A document in response to any further developments.