ECOWAS Essential Medicines & Vaccines

ECOWAS Essential Medicines & Vaccines WA-MRH

Author: WAHO

Category: Medical Products Dossier Evaluation and Registration

Language: English

Description This is a procedure for joint assessment by the Expert Working Group on Medical Products Dossier Assessment of the selected medicinal products, inspection of their respective manufacturing site(s) followed by Steering Committee approval of jointly accepted medicinal products.

Abstract Joint Medicines Dossier Evaluation Procedure This is a procedure for joint assessment by the Expert Working Group on Medical Products Dossier Assessment of the selected medicinal products, inspection of their respective manufacturing site(s) followed by Steering Committee approval of jointly accepted medicinal products. If the assessment of medicinal products dossier is successfully completed and jointly accepted, the ECOWAS Member Sates NMRAs will grant marketing authorization within maximum of three (3) months from the date of joint acceptance. The Marketing Authorization Holder (MAH) can begin to make the medicine available to patients and healthcare professionals in ECOWAS Member States where marketing authorization has been granted.

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Regional Joint Assessment Procedure for Medicine Registration and Marketing Authorization of Medicinal Products