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RE: Importation from outside the EU
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Dear Andrew Just to confirm what John says below is correct--the testing site can indeed be in a different EU member site. The TA however should be in place though not just for “commercial reasons” It is perfectly possible for all sites to be remote from each other--in other words importation site, testing site and release site can all be in different places and even in different EU countries. There are two provisos, as another contributor said: 1. There is a clear and precise TA between all involved sites (preferably signed by the releasing QP) which defines the mutual responsibilities of each site. 2. The MA for the particular product correctly reflects the three sites involved (ie they are named in the correct sections of the AF) and each site is itself correctly approved for the activity involved. For example, the importer may be a duly licensed warehouse, the testing laboratory may be a duly approved testing laboratory and the site of release has a ML (this is mandatory, of course). The only other thing worth mentioning is that the EU site of release becomes the EU responsible manufacturer and it is this site which is named as the manufacturer on the PIL of the product for the EU. Please don’t hesitate to contact me directly if you want any further advice/guidance Kind regards Alan Longworth Norpharm Regulatory Services, Correspondence address: Tullaghmeelan, Grange, Clonmel, Co. Tipperary, Ireland Phone: 00 353 52 6138880 Fax: 00 353 52 6138881 Mobile: 086-823-1905 www.norpharm.ie -----Original Message----- From: gmp@www2.pharmweb.net [ mailto:gmp@www2.pharmweb.net] On Behalf Of Downing, Andrew Sent: 08 January 2010 09:11 To: GMP Forum Subject: 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 No virus found in this incoming message. Checked by AVG - www.avg.com Version: 9.0.725 / Virus Database: 270.14.129/2606 - Release Date: 01/07/10 19:35:00 |
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