Food and Medicine Administration Proclamation (No. 1112/2019)
Food and Medicine Administration Proclamation (No. 1112/2019)
Introduction: This proclamation was enacted to protect public health from unsafe food, inefficacious medicine, and poor-quality medical devices. It provides the legal framework for the regulation, inspection, and control of these products within Ethiopia.
Key Highlights:
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Registration and Licensing: No food, medicine, or medical device may be placed on the market without being registered and granted a marketing authorization by the regulatory body.
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Quality Standards: Producers and distributors must comply with international standards, including Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
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Suspension and Revocation: The authority has the power to suspend or revoke professional or business licenses if the safety and quality standards are breached.
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Enforcement and Penalties: Strict administrative and criminal penalties, including heavy fines and imprisonment, are established for those who produce or distribute counterfeit or substandard health products.