Product Registration

Section 62 of the PMRA Act requires that both human and veterinary medicines on the Malawi market are issued with a marketing authorization/product license after the Board is satisfied that the product has met the required standards of quality, efficacy, and safety.

Administratively, dossiers are submitted to the office of the Director General and will be accepted upon verification of dossiers format, number of samples and evidence of payment of registration fee.

The Authority accepts dossiers which are in common technical document (CTD) format as per ICH M4Q or WHO TRS 970 annex 4. This application requires completion of PMRA new product registration form (8A) below.

There are three ways of submission of product registration namely, routine procedure where full assessment is done by PMRA assessors; WHO Collaborative Registration Procedure for products which are WHO prequalified; and ZAZIBONA collaborative registration procedure where SADC countries jointly share and discuss dossier assessment report

Assessment reports are approved by the board of Directors upon recommendations of the Medicines Committee of the PMRA. Upon approval, the product is licensed and incorporated into the List of Registered Products for Malawi.