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Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market.

Hiiti B SilloNelson E MasotaSunday KisomaLembit RagoVeronica MgoyelaEliangiringa Amos Kaale
Published in: PloS one (2018)
Our study revealed the existence of a significant number of medicinal products circulating on the markets of EAC Partner States without necessary compliance with all product information requirements. We therefore recommend that NMRAs ensure thorough pre-market assessment of product information as well as strengthening their post marketing surveillance to ensure that medicines circulating on the market comply to medicines information requirements at all times. Emphasis should also be given to manufacturers on the importance of inclusion of appropriate and adequate product information for the safety of patients, including advocating for inclusion of patient-friendly and easy to understand medicines information.
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