Plasma Master File (PMF) background documents

• Plasma Master File (PMF)

Procedural/regulatory announcements

PMF dossier requirements - Questions and answers for PMF holders

AdoptedReference Number: EMA/CHMP/BWP/721411/2022

Procedural Announcement - Temporary derogations to certain eligibility criteria for whole blood and blood components donors in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic

Reference Number: EMA/715726/2009

Commission Directives

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

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

Adopted

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...

Adopted

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

Adopted

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 ...

Adopted

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...

Adopted

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...

AdoptedReference Number: (EC) No 1085/2003

Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (notified under document number C(2002) 1344)

Adopted

• Copyright applies: EDQM - European pharmacopoeia

• WHO - Quality and safety of blood products

Statements / Reports

Report of plasma master file epidemiology workshop with industry

Reference Number: EMEA/CHMP/BWP/233408/2009

CHMP reflection paper on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products - Revision 3

AdoptedReference Number: EMA/CHMP/BWP/303353/2010 Rev 3

CPMP position statement - non-remunerated and remunerated donors: safety and suply of plasma-derived medicinal products

AdoptedReference Number: EMEA/CPMP/BWP/1818/02 Final

EMEA workshop on the plasma master file - 10-11 October 2001 - Report

AdoptedReference Number: EMEA/CPMP/BWP/1737/02