Regulatory Requirements and Enforcement Practices for Importation of Medicines for Personal Use into Ethiopia
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Date
2023-07
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Addis Ababa University
Abstract
Background: Evidence shows that some medicines imported for personal use are poor
quality and counterfeited. In Ethiopia, although travelers import medicine for their personal use,
little is known what medicines, and how frequently is being imported.
Objectives: To assess importation patterns, regulatory requirements, and enforcement
practice of medicine importation for personal use in Ethiopia.
Method: A sequential exploratory mixed methods design was used to assess importation
pattern, regulatory requirements and enforcement practices of personal medicine importation in
Ethiopia. Secondary documents analysis and one-to-one interviews were used for data collection.
Quantitative and qualitative data were analyzed using Microsoft Excel and thematic analysis
approach, respectively.
Results: Importing medicines for personal use have accelerated dramatically; records show
that 56 travelers imported 151 medicines in 2020 and 398 travelers‟ imported 920 medicines in
2021. Releasing medicines without EFDA approval, gaps in the rules and regulations, shortage
of some medicines and lack of coordination between key stakeholders were identified as
contributing factors for the rise in the importation of personal medications.
Conclusion: Importing medicines for personal use without a prescription is a growing
concern in Ethiopia. The EFDA should strengthen the regulatory system; restructure existing law
enforcement operations for the importation of medicine for personal use, and engage in high-
level discussions with stakeholders.
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Keywords
Personal Medicine, importation, regulatory practice & requirement.