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Re: QP release for IMPs


I am under the belief that none of the EU countries are presently requiring
QP release for IMP's !?!

The Clinical Trials Directive (2001/20/EC), although finalised and written
into legislation, will not be effectively implemented until spring 2004.

The QP release of IMP's is still not confirmed, and there has been no
indication of a finalised decision on a transitional 'grandfather' clause,
or whether there will be a totally separate QP status for these materials
(like QP(V) with veterinary medicines).

If anyone is aware of recent information on this issue, please do share it
with the group.  I personally think that 'Industry' should maybe put a
little more pressure on the Regulatory Authorities to get a decision made,
as I personally know of people training to be QP's simply because it is
possible that a person with that status might be required for material
release, with some of them completing training that they maybe don't
totally require (unless they wish to be full QP's for all products in the
future of course).

The legislation is there and ready to go, but how it is going to be
implemented seems to be a bit of a muddy puddle at the moment, what is the
MCA's view on this situation?



Martin Dennison. BSc (Hons), GIBiol, AIQA
Quality Systems Manager
Seven Seas Limited
E-mail: martin.dennison@sseas.com

                    "Steve Williams"                                                                                                
                    <steve_williams@dh       To:     "GMP Forum" <gmp@www2.pharmweb.net>                                            
                    pclin.com>     (by       cc:                                                                                    
                    way of John Dolman       Subject:     QP release for IMPs                                                       
                    Sent by:                                                                                                        
                    06/02/03 08:29                                                                                                  
                    Please respond to                                                                                               
                    "GMP Forum"                                                                                                     

Which EU countries ( if any) are already insisting on QP release for
investigational medicinal products.

Steve Williams
DHP pharma

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