Islamabad, Dec 30: The UAE has introduced a new law to regulate medical products, pharmacies, and pharmaceutical businesses. The law, announced on December 29, 2024, aims to improve the organization, security, and oversight of medical product development and distribution.
It covers a wide range of items, including medical devices, pharmaceutical products, healthcare items, biological products, supplements, and cosmetics, extending to biobanks and pharmaceutical establishments in free zones.
The law establishes guidelines for licensing, supervision, and management and addresses ownership transfers, outlining the roles of the Emirates Drug Establishment, the Ministry of Health, and local health authorities.
Violations of the law may lead to actions such as temporary license suspensions, precautionary closures, license cancellations, and fines, which could reach AED 1 million for establishments and AED 500,000 for practitioners.
Key Provisions of the Law:
- Regulation of Medical Products: Covers the entire lifecycle of medical products, including development, manufacturing, pricing, import, export, distribution, and disposal.
- Marketing Authorizations: Introduces various authorizations, including exclusive, conditional, and emergency use, with a fast-track process for significant medical products.
- Innovation Protection: Provides mechanisms to protect pharmaceutical innovations and establish regulatory protection periods.
- Pharmaceutical Policies Committee: Creates policies for the circulation, pricing, and monitoring of medical products.
- Investment and Innovation: Promotes investment and innovation in the pharmaceutical sector.
- Pharmacovigilance: Establishes procedures to ensure the safe use of medical products and minimize side effects.
- Strategic Inventory Policy: Develops a national strategy for the strategic stockpiling of medical products.
Scope of the Law:
The law applies to:
- Products: Medical, pharmaceutical, healthcare, biological, and genetically modified organism products, as well as dietary supplements, cosmetics, and controlled hazardous products.
- Establishments: Includes pharmacies, research entities, pharmaceutical labs, biobanks, factories, consulting firms, marketing firms, and medical warehouses.
Licensing and Oversight:
- Emirates Drug Establishment: Responsible for issuing licenses for medical products and overseeing their import, export, marketing, and ensuring compliance with Good Practices in the pharmaceutical industry.
- Ministry of Health and Local Health Authorities: Tasked with licensing and monitoring pharmacy professionals, pharmacies, and medical stores, as well as overseeing blood storage units and coordinating licensing databases.
Coordination and Enforcement:
The law promotes collaboration among various entities to share licensing information, integrate databases, and ensure consistent enforcement of regulations.
