27/28 April 2023
In a communication published at the end of last year, the UK Department of Health & Social Care clarifies that it remains committed to the acceptance of batch testing and certification by a Qualified Person (QP) carried out in the EU.
The background to this was a previous public consultation seeking views on four options for a future batch testing policy in the UK in the absence of an appropriate MRA. A range of stakeholders not only from the UK but from around the world provided feedback on this. The majority of responses were in favour of not requiring import testing in the UK or certification of medicines by a UK QP if they are on a list of countries approved for import.
The government has thus subsequently decided to maintain the list of countries approved for importation that do not require import testing or UK QP certification.
Here it is important to understand that the "list of approved countries for import" consists of sub-categories.
Two of the subcategories are:
1. List of countries approved for import. This includes only EEA countries and provides for the recognition of QP certification by a so-called UK Responsible Person (import) - RPi of a holder of a Wholesale Distribution Authorisation for human use (WDA(H)) in the UK.
2. List of countries approved for batch testing. This list includes EEA countries and MRA partners and provides for the recognition of batch testing. MRA partners are not included in List 1, so imports from these countries must be done via a Manufacturing and Importation Authorisation Holder (MIAH) and then require UK QP certification.
However, UK legislation allows for new countries to be included in both sub-categories in the future.