Aiming for Enhanced Security and Oversight in Pharmaceutical and Healthcare Sectors
The UAE has introduced a new law on December 29, 2024, to regulate medical products, pharmaceutical businesses, and related establishments across the country. The law, targeting products like medical devices, pharmaceuticals, supplements, and cosmetics, aims to improve security, organization, and oversight throughout the development and distribution processes.
Key Provisions of the Law
The new regulations encompass a wide range of products and establishments:
- Medical Devices
- Pharmaceutical Products
- Healthcare Items
- Biological Products
- Supplements
- Cosmetics
- Biobanks
The law governs the full lifecycle of these products, including their development, manufacturing, import/export, marketing, pricing, safe disposal, and use.
Licensing and Oversight
The law establishes a robust framework for the licensing and supervision of pharmaceutical establishments and biobanks. It addresses processes such as ownership transfers and outlines the responsibilities of regulatory bodies like:
- The Emirates Drug Establishment
- The Ministry of Health
- Local Health Authorities
Disciplinary Actions for Violators
Violations of the law can result in strict penalties, including:
- Temporary suspension of licenses
- Precautionary closure
- License cancellation
- Fines of up to Dh1 million for establishments and Dh500,000 for practitioners
Specific Products and Professions Covered
This law applies to a wide array of products and establishments, such as:
- Pharmacies and Pharmacy Chains
- Compounding Pharmacies
- Pre-clinical and Clinical Research Entities
- Pharmaceutical Laboratories and Factories
- Marketing Firms
- Medical Warehouses
- Medical Stores
- Biobanks
Fast-Tracking Innovative Products
To promote innovation, the law introduces a fast-track mechanism for granting marketing authorisations to products of therapeutic importance. Additionally, the law aims to protect intellectual property and foster investment in the pharmaceutical sector.
Pharmacovigilance and Safe Use
The law outlines mechanisms for pharmacovigilance to ensure safe use of medical products, while also reducing potential side effects. Furthermore, it supports the establishment of a strategic inventory of medical products to enhance national preparedness.
Licensing and Monitoring Authorities
- The Emirates Drug Establishment will handle key tasks such as:
- Licensing medical products
- Approving import, export, and re-export
- Issuing certifications for Good Practices
- Supervising factories, warehouses, and consulting firms
- Local health authorities will monitor biobanks, research organizations, and bioequivalence centres, ensuring that products are safely disposed of and complying with national regulations.
This law aims to provide a more organized and secure framework for the UAE’s pharmaceutical and healthcare sectors, improving transparency, accountability, and efficiency. The introduction of these regulations will help to streamline operations while ensuring that public health and safety are protected.
