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Publication Years
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Category
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Toolboxes
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4
Guidance for the preparation and submission of dossiers
This guide provides national stakeholders and advocates with information and guidance to update the national essential medicines list to include a new commodity, a new indication, or a new formulation based on the available evidence and based on country need and disease burden. While the actors, tim
...
eline, and process may vary from country to country, this guide presents the broad steps involved in revising an EML for any health commodity. Additional resources and a glossary are included to provide supplemental information and to clarify key terms.
more
2006-2008 programme report
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,
...
which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
more
Last revised 2015.
Original Word document on: http://www.epnetwork.org/Resources/Standard%20Operating%20Procedure/Supplier%20Delivery%20Note_Form.doc
