Plasma Master File (PMF) background documents
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COMMISSION DIRECTIVE 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (PDF/377.6 KB)
First published: 27/06/2003
Last updated: 27/06/2003 -
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Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use (PDF/228.46 KB)
Adopted
First published: 10/09/2004
Last updated: 10/09/2004 -
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Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood com... (PDF/241.23 KB)
Adopted
First published: 07/02/2003
Last updated: 07/02/2003 -
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Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (PDF/200.05 KB)
Adopted
First published: 29/03/2004
Last updated: 29/03/2004 -
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Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and ... (PDF/62.6 KB)
Adopted
First published: 29/03/2004
Last updated: 29/03/2004 -
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Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for bloo... (PDF/60.09 KB)
Adopted
First published: 30/09/2005
Last updated: 30/09/2005 -
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Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling wi... (PDF/233.4 KB)
Adopted
First published: 26/06/2003
Last updated: 26/06/2003
(EC) No 1085/2003 -
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Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (notified under document number C(2002) 1344) (PDF/236.37 KB)
Adopted
First published: 15/05/2002
Last updated: 15/05/2002
- Copyright applies: EDQM - European pharmacopoeia
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Report of plasma master file epidemiology workshop with industry (PDF/87.41 KB)
First published: 19/11/2009
Last updated: 19/11/2009
EMEA/CHMP/BWP/233408/2009 -
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CPMP position statement - non-remunerated and remunerated donors: safety and suply of plasma-derived medicinal products (PDF/116.84 KB)
Adopted
First published: 30/05/2002
Last updated: 30/05/2002
EMEA/CPMP/BWP/1818/02 Final -
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CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products - Revision 2 (PDF/209.05 KB)
Adopted
First published: 28/06/2011
Last updated: 28/06/2011
EMA/CHMP/BWP/303353/2010 -
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EMEA workshop on the plasma master file - 10-11 October 2001 - Report (PDF/230.52 KB)
Adopted
First published: 18/12/2002
Last updated: 18/12/2002
EMEA/CPMP/BWP/1737/02