COMMISSION NIBS
August 1st, 2004
BY KEITH NUTHALL
THE EUROPEAN Commission has released guidelines on producing plasma and vaccine antigen master files during marketing approval and certification procedures: http://pharmacos.eudra.org/F2/eudralex/vol-2/C/2ndstepvamfpmf_08_2004.pdf. It has also updated guidelines on applications for orphan medicinal products designations:
http://pharmacos.eudra.org/F2/orphanmp/doc/2004_07/orphan_application_200407.pdf
THE EUROPEAN Commission has released guidelines on producing plasma and vaccine antigen master files during marketing approval and certification procedures: http://pharmacos.eudra.org/F2/eudralex/vol-2/C/2ndstepvamfpmf_08_2004.pdf. It has also updated guidelines on applications for orphan medicinal products designations:
http://pharmacos.eudra.org/F2/orphanmp/doc/2004_07/orphan_application_200407.pdf
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