Last year, the UK Department of Health & Social Care issued a statement emphasizing their continued support for the acceptance of batch testing and certification by a Qualified Person (QP) performed in the EU. This statement came after a public consultation seeking opinions on four potential options for a batch testing policy in the UK without a Mutual Recognition Agreement (MRA). Stakeholders from the UK and other countries weighed in, with the majority expressing support for not requiring import testing or UK QP certification for medicines on a list of approved countries for import.
The UK government decided to maintain this list of approved countries, which is divided into two subcategories. The first subcategory includes EEA countries and recognizes QP certification by a UK Responsible Person (import). The second subcategory includes EEA countries and MRA partners, recognizing batch testing but not QP certification for imports from MRA partners. Imports from MRA partners not included in the first subcategory must go through a Manufacturing and Importation Authorization Holder (MIAH) and require UK QP certification. It is worth noting that the UK has the flexibility to add new countries to either subcategory in the future.
In summary, the UK remains committed to accepting batch testing and QP certification performed in the EU, and has decided to continue its current policy of recognizing a list of approved countries for import without requiring additional testing or certification. This decision was based on feedback from a public consultation, and the list of approved countries is divided into two subcategories that allow for different levels of recognition depending on the country of origin.