Tag: products revision

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dossier requirements

Documents Variations to a prequalified product Hua YIN Prequalification of Medicines Programme QSM / EMP / HSS...

Slide 1 Variations to a prequalified product Hua YIN Prequalification of Medicines Programme QSM / EMP / HSS WHO Prequalification Programme: Training workshop March 2010,…

Documents Sultan Ghani WHO Prequalification Programme of Priority Essential Medicines, 11-13 October 2010, Abu...

Slide 1 Sultan Ghani WHO Prequalification Programme of Priority Essential Medicines, 11-13 October 2010, Abu Dhabi, U.A.E. Dossier Requirements for Generic Medicines and…

Documents evaluation-manual-biocides-nl---7---disinfectants---version-1-4-2013.pdf

Evaluation Manual for the Authorisation of plant protection products and biocides NL part Biocides Chapter 7 Efficacy version 1.4; September 2013 Authors: Lonne Gerritsen,…

Documents Welcome to a 7 minute presentation on h ow to manage the 2013 deadline

Slide 1 Welcome to a 7 minute presentation on how to manage the 2013 deadline REACH deadline 2013 REACH Registration Timeline 1 â 100 t/y 100 â 1000 t/y >1000 t/y 1st…

Documents Welcome to a 7 minute presentation on h ow to manage the 2013 deadline

Slide 1 Welcome to a 7 minute presentation on how to manage the 2013 deadline REACH deadline 2013 REACH Registration Timeline 1 â 100 t/y 100 â 1000 t/y >1000 t/y 1st…

Documents Post Approval Stability Studies

Slide 1 Post Approval Stability Studies LEARNING OBJECTIVES Awareness of ICH / EMA / other Stability Guidelines Understand minimum requirements for Routine Stability study…