In a recent letter, the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) requested firms with centrally authorized products (CAPs) take more preparatory actions in the event of a no-deal Brexit.
MHRA intends to convert existing CAPs into UK marketing authorizations (MAHs) if Britain and the EU fail to reach an agreement ahead of the 29 March 2019 Brexit deadline.
“To facilitate the grandfathering process, the MHRA has assigned a product license number to CAPs based on the existing UK practice for national licenses,” the agency said.
The letter was sent to firms’ heads of regulatory affairs on 2 January and posted on MHRA’s website Monday—a little under a week after the UK’s Brexit withdrawal agreement fell through
. UK Prime Minister Theresa May has not ruled out delaying the departure to avoid unintended consequences.
“Delivering the deal negotiated with the EU remains the government’s top priority. This has not changed,” MHRA said on Monday. “However, the Government must prepare for every eventuality, including a no deal scenario. While it is not our policy or our preferred approach, we must ensure plans are in place for a no deal scenario should they need to be relied upon.”
MHRA has been preparing the pharmaceutical industry for the grandfathering of CAPs, which are currently valid across all the EU member states, Iceland, Norway and Liechtenstein. With the proposed requirements for the transition to MAHs set in a November 2018 letter, MHRA advised
pharmaceutical companies to notify it of plans to opt-out of the grandfathering process by the end of this month.
MRHA’s latest letter
on the matter stressed the deadline is 22 April 2019, after which products that were not converted “will not longer licensed in the UK” and “can no longer be placed on the market in the UK.”
In addition to actions MHRA listed last November, the agency identified three new actions holders of CAPs “are requested to take” in order to “ensure that the grandfathering process runs smoothly.” These call on holders to advise MHRA of any products that have been withdrawn or cancelled and whether MAH company numbers assigned to the agency’s list of products are incorrect. “If possible, advise use of a single point of contact for all your products,” MHRA added.
Conversion of Community Marketing Authorisations to UK Marketing Authorisations – letter to industry