|
|
Importation from outside the EU
|
Andrew, I assume you are talking about a product with a UK MA and not a centralised MA. The MA will define the responsibilities of the various parties involved. You should examine it carefully to see how it defines the site of importation, the site of testing and the site of release. I believe that the site of testing can be in a different Member State to the site of importation but I am not sure whether the site of release can be remote from the site of importation. If your UK MA states that you are the importer then you will have an MIA to authorise the importation and the QP named on that MIA is responsible for the certification for release. If you rely on the (equivalent) MIA in another Member State and the QP based there then be sure that the arrangement is clearly defined in the MA. If the MA does allow the arrangement for the QP in the other Member State to release the product then you will, for commercial reasons, still want suitable TAs in place to ensure that your company is protected. Best wishes, John Dolman (website Moderator) 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® _________________________________________________ This message is for the designated recipient only and may contain privileged, proprietary or otherwise private information. If you have received it in error, please notify the sender immediately and delete the original. Any other use of the email by you is prohibited. Dansk - Deutsch - Espanol - Francais - Italiano - Japanese - Nederlands - Norsk - Portuguese Svenska: www.cardinalhealth.com/legal/email |
|
|