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Europe and UK

ACSS Worksharing Consortium

ACSS Worksharing Consortium

ACSS Worksharing Consortium

 Agency Web SIte (ACSS Consortium)

 FRP Detail Summaries

 FRP Flow Chart

England (MHRA)

ACSS Worksharing Consortium

ACSS Worksharing Consortium

 Agency Web SIte (MHRA)

 FRP Detail Summaries

 FRP Flow Chart

European Medicines Agency (EMA)

European Medicines Agency (EMA)

European Medicines Agency (EMA)

 Agency Web SIte (EMA)


FRP Detail Summaries

 

EMA Accelerated Assessment

    EMA Adaptive Pathway (regulatory HTA parallel advice)

    EMA Advanced Therapy Medicinal Product

    EMA Article 58

    EMA Conditional Marketing Authorization

    EMA Exceptional Circumstances

    EMA Orphan Designation

 EMA PRIME


FRP Flow Chart

Switzerland (Swissmedic)

European Medicines Agency (EMA)

European Medicines Agency (EMA)

 Agency Web SIte (Swissmedic))

MAGHP FRP Detail Summaries

Article 13

 FRP Flow Chart

Download FRPs

ACSS Consortium - FRP detail 26jul2020 (pdf)

Download

EMA Article 58 - FRP detail 25apr2020 (pdf)

Download

EMA - ATMPs FRP detail 19jul2020 (pdf)

Download

EMA - CMA FRP detail 19jul2020 (pdf)

Download

EMA - Exceptional Circumstances FRP detail 19jul2020 (pdf)

Download

EMA - Adaptive Pathways FRP detail 19jul2020 (pdf)

Download

EMA - Orphan Designation FRP detail 30mayl2020 (pdf)

Download

EMA - Accelerated Assessment FRP detail 30may2020 (pdf)

Download

EMA PRIME FRP detail 28Aug2019 (pdf)

Download

Swissmedic - Article 13 FRP detail template 19jul2020 (pdf)

Download

Swissmedic - MAGHP FRP detail 20apr2020 (pdf)

Download

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