While not sure of a specific answer since I have not read the FDA document,
it might be worth checking at two sites: (1) the Biologicals Working Party
section of the EMEA web page (via www.eudra.org) and (2) the Enterprise
Directorate General web page at dg3.eudra.org, and specifically on that part
of the page relating to Rules Governing Medicinal Products in the EU - there
are various places where the information may be found including under
legislation and guidelines for biologicals and biotechnology products.
Regards,
Brian Matthews
lt09@dial.pipex.com
|