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Rwanda 🇷🇼
Guidelines for Control of Promotion, Advertisement and Marketing of Medicines, Medical Devices and Cosmetics in Rwanda (DIS/GDL/050)
These guidelines, issued by the Rwanda Food and Drugs Authority (Rwanda FDA), set out the requirements for the promotion, advertising, and marketing of medicines, medical devices, and cosmetics in Rwanda.
The framework ensures that promotional activities provide accurate, truthful, and balanced information, protecting both healthcare professionals and the public from misleading or exaggerated claims.
Use Cases
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Scope of application: applies to manufacturers, wholesalers, retailers, dealers, applicants, and any individual or organization intending to promote or advertise regulated products.
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Prohibitions: bans on advertising unregistered products, making misleading claims, targeting children under 18, offering gifts/rewards tied to sales, or using unauthorized endorsements.
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General requirements: adverts must be accurate, clear, balanced, and in official languages of Rwanda; promotional materials must be pre-approved by Rwanda FDA.
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Special requirements: specific rules for prescription medicines, OTC medicines, traditional medicines, veterinary medicines, medical devices, and regulated cosmetics.
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Stakeholder responsibilities: clear roles for healthcare professionals, medical representatives, media, law enforcers, and the general public in ensuring compliance.
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Complaints system: establishes procedures for reporting misleading or unlawful promotions.
Key takeaways you'll learn
