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Category Select Medical Products Dossier Evaluation and Registration Good Manufacturing Practices and Inspections Clinical Trials, Pharmacovigilance and Medicines Safety Quality Control Laboratories Quality Management Systems Information Management Systems Policy, Legislation and Regulation

Abstract The West Africa Medicines Regulation Harmonization (WA-MRH) Project has agreed a single process for regional medical product evaluation to enable the registration of medicinal products in the 15 ECOWAS Member States. This call is an invitation to manufacturers of anti-malaria medicines to submit Expressions of Interest (EOI) for the Regional Joint Medical Products evaluation for registration under this project. The invitation is published in accordance with the document titled “WA-MRH Regional Joint Medical Product Evaluation Procedure for pharmaceutical product dossier”, which is dated July 2019 and is available on WAHO Website (www.wahooas.org) under the section “WAHO Programs and Projects”, sub-section “WA-MRH Project”. Assessment of product(s) submitted under this invitation will include evaluation of: • product dossiers, which must include product data and information as specified in the guidelines for submission. • manufacturing sites, which must adhere to good manufacturing practices (GMP) • product samples, which must adhere to the requisite specifications.

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Document Type Select SOP Form EOI