Announced on Sunday, the law covers medical devices, pharmaceutical products, healthcare items, biological products, supplements, and cosmetics. It also governs biobanks and pharmaceutical establishments operating across the country, including those in free zones.
The new law establishes a framework for licensing, supervising, and overseeing pharmaceutical establishments and biobanks, addressing ownership transfers, and defining the roles of the Emirates Drug Establishment, the Ministry of Health, and local health authorities.
Violators of the law face disciplinary actions, including temporary suspension of the license, precautionary closure, license cancellation and fines of up to Dh1 million for establishments and Dh500,000 for practitioners.
The following are the key provisions of the law:
Regulating the management of medical products, including their development, manufacturing, registration, pricing, import, export, circulation, distribution, possession, sale, marketing, use and safe disposal.
Regulating issuance of marketing authorisations for medical products, including exclusive authorisation, conditional authorisation and emergency use authorisation.
Developing a fast track for granting marketing authorisations for innovative medical products of therapeutic importance.
Setting mechanisms to protect innovations in the pharmaceutical industry sector and period of regulatory protection.
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