United Arab Emirates, like other jurisdictions, regulates medical products through various legislations, rules and regulations, including their manufacturing, export, import, marketing, promoting and advertising and their selling.
Introduction:
Medical products are understood to mean all kinds of medicinal drugs, medical devices and other healthcare products used for the general health of humans. This definition has been provided under the Federal Law No 8 of 2019 on Medical Products, Profession of Pharmacy and Pharmaceutical Institutions (Medical Products Law).
Article 1 of the Medical Products Law states as follows:
“Medical Product: Every Medicinal Product or Medical Device or Healthcare Product”
Trading of Medical Products
Any medical product cannot be traded in the United Arab Emirates unless a license or a marketing authorisation has been granted by the Ministry of Health and Prevention under Article 3 of the Medical Products Law.
A marketing authorisation has been defined under Article 2 of the Medical Products Law as a license to engage in the marketing of a medical product, and in charge of all aspects of marketing, promotion and follow up in the UAE.
If a person violates Article 3 of the Medical Products Law, i.e., trades in a medical product without a license or marketing authorisation, will be punished with imprisonment between 1 year to 5 years, and / or fines between AED 100,000 to AED 500,000.
There is also an additional punishment provided under the Cybercrime Law if unlicensed medical products are promoted or sold in the UAE online, by way of a website or other information network. Under Article 49 of the Federal Decree-Law No. 34 of 2021 Concerning the Fight Against Rumors and Cybercrime, any person who creates, manages or supervises a website or publishes information on the information network or by any information technology method to promote or sell medical products not licensed in the UAE or copying licensed medical products shall be sentenced to detention and/or to pay fine.
What are Falsified Medical Products?
Falsified products are defined under Article 1 as those medical products which are prepared deliberately with the intention of fraud or to mislead. The fraud and misleading products could be by providing false or incorrect information regarding the identity or source of the product which is included in the packaging, container of the ID label or information leaflet.
It could also include acts of imitating another medical product by using the same shapes and colors of the packaging, container and label of the original product or through adding or removing a substance or composition from the packaging, container or the labels without the approval of the authorities. Any change in the quantity or volume of the substances in the product without the permission of the competent authorities is also a falsified product.
Falsified medical products are not allowed to be traded under Article 42 of the Medical Products Law.
A medical product could be ordered to be withdrawn under Article 11 of the Medical Products Law if it is established that the medical product is falsified.
License of a manufacturer of the medical products may also be cancelled by the competent authorities in case of manufacturing or trading of falsified products.
Conclusion
The penalties prescribed for trading unauthorized medical products is significant and therefore, any violations could potentially result in criminal sanctions.
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