23/24 February 2021
If the UK leaves the EU without a deal ("Hard Brexit"), supply chains for products sourced from the European Union and European Economic Area (EEA) may be affected. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has now published new Guidance to clarify and support pharmaceutical industry and importers in UK. And this Guidance introduces a new Responsible Person function, the RPi - Responsible Person (import).
MHRA points out that a wholesale dealer's licence will remain in force on the day the UK leaves the EU. This licence will also be deemed to permit the importation of medicinal products into countries in the European Economic Area (EEA). But this will only apply if companies in UK undertook the following actions:
"Within 6 months from exit day, notify MHRA in writing of your intention to continue to import medicinal products from a country on the list". To import a UK authorised medicine from an EEA country a wholesale dealer's licence that authorises import will be needed.
"Within 2 years from exit day, nominate and have named on your wholesale dealer's licence a Responsible Person (import) (RPi)". A new Guidance describes roles and responsibilities of this RPi.
Currently, for importation from EU an Importation Licence is not needed; only a Wholesale Distributor Authorisation (WDA), with a Responsible Person (RP) to manage the quality related activities (as described in the EU GDP guidelines). Post Brexit (with no applicable deal), an Importation Licence will be needed to import products from EEA countries into the UK. UK companies and importers can add this Importation Licence to their WDA. And they will need an RPi to manage the importation activity (UK will continue to accept batch certification by the EU QPs).
However companies from EU and EEA countries importing from UK will require a QP for batch certification! Batch certification by UK QPs will not be accepted.
"The shipment of medicines by air freight requires specific control measures". MHRA's guidance now wants to provide advice on Good Distribution Practice (GDP) requirements especially for air freight. The guidance refers to both EU and WHO GDP (World Health Organization technical series 961 and WHO Supplement 12) and covers the following aspects: