General information for Plasma Master File (PMF) applicants

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Electronic Common Technical Document (eCTD)

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Document(s) Language Status First published Last updated Effective Date
Practical_guidelines on the use of the eCTD format for Plasma Master File holders (PMF - H) (English only)   2009-08-01    

Coordinators list

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Application form - PMF holders

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  • On June 7 2012 the European Medicines Agency launched a new electronic form for submitting applications for plasma master file (PMF) certificates to the Agency. This replaced the word-format document, Application for an EMA Certificate for a Plasma Master File (PMF) and the document, Variation application – annex to the application form.

Transfer of PMF-holder - checklist appendix - PMF holders

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Document(s) Language Status First published Last updated Effective Date
Appendix - checklist for the transfer of PMF to a new Holder (English only)   2009-10-07    

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Note: Transfer of PMF to a new Holder since 01.01.2010 is handled as PMF variation application. Applicants applying for PMF transfer should attach checklist to the variation application.

PMF 2nd step checklist - appendix - MAH

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Document(s) Language Status First published Last updated Effective Date
Appendix for a 2nd step Notification (EMA) (English only)   2009-10-08    

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Note: PMF 2nd step procedure since 01.01.2010 is handled as MA variation procedure. MAHs should attach 2nd step Appendix to the variation application.

Fees

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Timetables

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