Brexit - Life Sciences
Critical issues for businesses in the Life Sciences industry to consider:
- Contingency Plans: Life sciences companies should anticipate the possible or potential consequences of Brexit on their regulatory strategy, supply chain and as well certain contractual matters and prepare a contingency plan as necessary.
- Clinical Trials for Human Medicines: Under the current clinical trial directive, Article 19 of Directive 2001/20/EC requires that the sponsor or a legal representative of the sponsor is established in the EU/EEA. The European clinical trial regulation EU No. 536/2014 (CTR) is due to come into force in 2020. Under the new CTR, where the sponsor of a clinical trial is not established in the EU, that sponsor is required to ensure that a natural or legal person is established in the EU as its legal representative.
- EU Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR): Brexit also places uncertainty on the transposition of the MDR and the IVDR by the UK, which are expected to be implemented in 2020 and 2022, respectively. While the UK government has communicated its intention to implement the CTR, MDR and IVDR into UK national law, the status of the Regulations and their implementation to UK entities post-Brexit remains uncertain.
- Medical Devices: For medical device companies, it is likely that manufacturers based in the UK may need to appoint an authorised representative based in the EEA and that the EEA operators buying from the UK manufacturers will be deemed to be importers. UK manufacturers will also need to change their notified body if their notified body does not relocate to the EU.
- Marketing Authorisation Holders: In accordance with Directives 2001/82/EC and 2001/83/EC, the marketing authorisation holder (MAH) must be located within the EU/EEA. MAHs should plan for a situation where the UK becomes a third country which involves selecting a Reference Member State (RMS) based in the EU/EEA and ensuring that the MAH is also based in the EU/EEA.
- UK MAH: Consideration should be given with regard to whether to submit a separate UK marketing authorisation application to the Medicines and Healthcare Regulatory Agency (MHRA) in the UK.
- Products under development: It is advisable that all planned regulatory activity with products requiring a change in RMS takes into account the expected duration of the procedures to ensure the RMS change is completed prior to 29 March 2019.
- Marketing authorisations for generic/hybrids granted in accordance with Directives 2001/82/EC and 2001/83/EU prior to 29 March 2019: These will continue to be valid authorisations notwithstanding that a reference medicinal product (RefMP) may no longer be an EU authorised product.
- Parallel Product Authorisations: Parallel product authorisations (PPAs) can only be granted for medicines imported from an EU Member State or a country within the EEA. Therefore, PPAs issued for products imported from the UK will cease to be valid post 29 March 2019.
- PPA holders: must be located within the EEA. Where the holder of PPA is currently located within the UK, the authorisation will need to be transferred to a holder located within the EEA.
- Variations to Marketing Authorisations to change Qualified Person Responsible for Pharmacovigilance (QPPV), manufacturing site or/and batch release sites: Any variations required for a marketing authorisation (MA), e.g change in location of QPPV or site of batch release, should be completed prior to Brexit.
- Orphan drugs: UK holders of orphan medicinal designations may need to transfer those designations from the UK to the EU/EEA based companies or alternatively set up an establishment in the EU/EEA.
- Movement of Pharmaceutical Goods: In the event of a no-deal Brexit, it is likely that any Irish company that receives finished medicinal products from the UK, will be required to hold a manufacturer’s/importer’s authorisation. In addition the batches must be tested and certified in the EU/EEA after importation. An Irish wholesale entity supplying the UK market will need to vary its authorisation to include the activity ‘export’ to continue this supply. Irish manufacturers of medicinal products that are supplied to the UK market will need to comply with any additional requirements that may be put in place by the UK competent authorities.
- Pharmacovigilance Operations: MAHs will need to ensure that their EU qualified person responsible for pharmacovigilance (QPPV) and their pharmacovigilance system master file (PSMF) are located within the EU/EEA.