The new role of “Responsible Person – Import” is among the proposals the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has developed through its engagement with stakeholders to prepare for the possibility of an unwanted “no-deal” exit of the UK from the European Union (EU).
An updated “Technical Notice” on the no-deal scenario, published on January 3, 2019, confirmed an earlier MHRA proposal that for batch testing of medicines, the UK would continue to recognise QP certification from EU/European Economic Area (EEA) countries. However, to ensure all medicines imported into the UK have been appropriately QP certified – including “introduced medicines” passing through EU/EEA in transit to the UK – an assurance system overseen by a “Responsible Person for Import” would need to be implemented, the notice indicates.
Addressed in the notice are a daunting list of other key issues for medicinal products relating to a no-deal scenario. These include: ● conversion of centrally authorized products (CAPs) into UK marketing authorizations ● new assessment route procedures ● a UK system for orphan medicinal products ● free scientific advice for UK-based small and medium size enterprises ● UK-based paediatric investigational plans and studies ● legal presence requirements ● amendments to packaging and leaflets ● UK reference products for new abridged applications ● parallel imports ● new fee structure, and ● new arrangements for certification of batches of immunological medicinal products or a medicinal product derived from human blood or plasma.
The technical notice provides proposals for addressing the no-deal Brexit issues for medical devices and clinical trials along with those for medicines. MHRA stressed that the proposals made across the technical notice will be subject to amendment and further guidance in the coming months. [A link to the notice is provided below.]
The contingency planning is being done in the effort to assure that the agency will be able to continue to protect patients and support innovation after the March 29, 2019 EU exit date, and that stakeholders can make informed plans and preparations, whatever the outcome of the negotiations. The notice stresses that “delivering the deal negotiated with the EU remains the government’s top priority.”
Reflecting a consultation with stakeholders during October, the January notice updates initial proposals outlined in August on modifications to legislation and regulatory processes in the event of the UK not securing a deal with the EU.
Seeking input on key issues from industry, allied healthcare professionals, medical charities, and the public, the consultation had a short comment period to allow sufficient time to lay revised proposals before the UK Parliament in early 2019 in anticipation of the exit date.
Brexit Strategy Discussed at MHRA GMDP Symposium
MHRA GMP/GDP Inspectorate Operations Unit Manager Richard Andrews shared the agency’s Brexit strategy and initial feedback on the consultation results at the annual MHRA GMDP Symposium in London on November 22.
He outlined the agency’s plans both in the event of a deal, with an implementation period, and no deal, where effectively the MHRA would be a stand-alone “third country” medicines and medical devices regulator, making decisions and carrying out functions currently done at the EU-level.