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Up to Dh1-million fine: UAE introduces new law to regulate medicines, pharmacies

The law applies to medical devices, pharmaceutical products, healthcare items, biological products, supplements, and cosmetics

Published: Mon 30 Dec 2024, 10:02 PM

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The UAE has introduced a new law to regulate medical products, pharmacies, and pharmaceutical businesses, aiming to enhance organisation, security, and efficient oversight of development and distribution processes.

Announced on Sunday (December 29), 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.

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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 the 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.
  • Establishing the Pharmaceutical Policies Committee, which is responsible for proposing policies related to the circulation, pricing, and monitoring of medical products.
  • Developing a system to foster investment and innovation in the pharmaceutical industry sector.
  • Organising pharmacovigilance procedures to ensure the safe use of medical products and reduce side effects.
  • Organising the issuance of the national policy for the strategic inventory of medical products.

The provisions of the law apply to the following products, professions and establishments:

Medical products

  1. Drug products
  2. Medical devices
  3. Pharmaceutical products
  4. Health care products
  5. Genetically modified organism products for medical use.
  6. Biological products
  7. Dietary supplements
  8. Cosmetics
  9. Chemical precursors, controlled, semi-controlled, hazardous and toxic products.

The law also applies to pharmaceutical establishments and biobanks operating in the state including free zones:

  1. Pharmacies and pharmacy chains
  2. Compounding pharmacies
  3. Pre-clinical and clinical research entities
  4. Bioequivalence centres
  5. Pharmaceutical laboratories
  6. Factories and contract manufacturing organisations
  7. Marketing firms
  8. Pharmaceutical consulting firms
  9. Medical warehouses and medical stores
  10. Biobanks
  11. Contract research and development organisations
  12. Other establishments as per cabinet resolution.

The law sets rules for licensing, managing, and monitoring pharmacies and biobanks. It covers how ownership of these businesses can be transferred and outlines the responsibilities of the Emirates Drug Establishment, the Ministry of Health, and local health authorities.

The Emirates Drug Establishment is responsible for several key tasks, including:

  • Issuing licenses for medical products to be sold.
  • Approving the import, export, and re-export of medical products.
  • Approving advertisements for medical products.
  • Issuing certificates for Good Practices in the industry.
  • Suspending or removing medical products at the national level.
  • Licensing and overseeing factories, contract manufacturers, medical warehouses, medical stores, marketing companies, pharmaceutical consulting firms, and laboratories.

The Emirates Drug Establishment and local health authorities each have specific responsibilities within their areas of jurisdiction:

  • They approve the safe disposal of medical products.
  • They license and oversee biobanks, pre-clinical and clinical research organisations, contract research and development organisations, and bioequivalence centres.

The Ministry of Health and Prevention and local health authorities each have specific responsibilities within their areas of jurisdiction:

  • They license pharmacy professionals.
  • They have the authority to suspend medical products in both government and private health facilities.
  • They license and monitor pharmacies, pharmacy chains, compound pharmacies, blood storage units in hospitals, and medical stores in government health facilities, which are limited to storage activities.
  • The law requires coordination between the relevant entities to share information about licenses issued, integrate databases, and collaborate on monitoring establishments.

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