What is defined as importing a medicinal product from
outside the EU?
The reason I ask is we are currently looking at importing a product
manufactured in country X (i.e. a country outside of the EU with no MRA
in place with an EU state). The product will physically come into the UK
and will ultimately be distributed to market from the UK. However, the
testing at entry into the EU will occur in another EU country (as testing
facilities aren’t available at the UK site) and the QP certification will
occur in the other EU country. In this specific example, both the UK and
“other EU country” sites are licensed for the import of this medicine (so
I feel we have suitable licences, systems, TAs etc. in place to look
after this specific product). But it got me thinking – from a legal
sense, who is classed as the importer – the UK site (who physically has
the stock) or the “other EU site” who conduct the testing and the QP
release?
Any thoughts would be gratefully received.
Andrew
Andrew Downing
Qualified Person & Vendor Assurance Manager, Martindale
Pharma®
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