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Quality Module of PDs for multisource products
Guidelines on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product for the WHO Prequalification of Medicines Programme: Quality Part. WHO Technical Report Series, No. 970, 2012, Annex 4
Quality and Safety: Medicines
Prequalification of Medicines
WHO Headquarters in Geneva
Pharmaceutical Development of Multisource (Generic) Finished Pharmaceutical Products – Points to Consider. WHO Technical Report Series, No. 970, 2012, Annex 3
Guidelines on Submission of Documentation for a Multisource (Generic) Finished Product. General Format: Preparation of Product Dossiers in Common Technical Document Format. WHO Technical Report Series, No. 961, 2011, Annex 15
Guidelines on Submission of Documentation for Prequalification of Innovator Finished Pharmaceutical Products Approved by Stringent Regulatory Authorities. WHO Technical Report Series, No. 961, 2011, Annex 11
Guidelines on Active Pharmaceutical Ingredient Master File Procedure. WHO Technical Report Series, No. 948, 2008, Annex 4
© WHO 2013
Last updated: May 3, 2013