emirates7 - The UAE Government has introduced a Federal Decree-Law aimed at regulating medical products, the pharmacy profession, and pharmaceutical establishments.
The law seeks to position the UAE as a globally trusted hub for pharmaceutical and medical industries, enhance pharmaceutical security, and streamline processes for developing, approving, manufacturing, marketing, and distributing medical products, all while adhering to international standards with competitive costs and timelines.
Scope and Applicability
The Decree-Law applies to a wide range of medical products, including drugs, medical devices, healthcare products, biological products, dietary supplements, cosmetics, and genetically modified organism products for medical use. It also governs chemical precursors, controlled substances, semi-controlled substances, and hazardous or toxic materials used in human and veterinary medicine.
Additionally, the law regulates all pharmaceutical establishments and biobanks within the UAE, including those in free zones. This includes pharmacies, pharmacy chains, compounding pharmacies, medical warehouses, manufacturing facilities, marketing firms, research entities, bioequivalence centers, biobanks, and other establishments designated by the UAE Cabinet. Practitioners of the pharmacy profession across the UAE are also subject to the law.
Regulatory Provisions
The Decree-Law outlines requirements for licensing, monitoring, and supervising pharmaceutical establishments and biobanks. It addresses ownership transfers, temporary suspensions, precautionary closures, and license revocations. Specific roles and responsibilities are assigned to the Emirates Drug Establishment, the Ministry of Health and Prevention, and local health authorities.
Pharmaceutical manufacturing facilities, marketing firms, and laboratories fall under the purview of the Emirates Drug Establishment, while biobanks and research entities are overseen by either the Emirates Drug Establishment or local health authorities. Pharmacies and storage facilities within government health centers are regulated by the Ministry of Health or local authorities.
Investment and Innovation
The law encourages investment in the pharmaceutical sector by introducing an incentive framework to attract investors and foster innovation. This framework will be established by the Cabinet based on recommendations from the Emirates Drug Establishment in collaboration with health authorities and stakeholders.
To protect innovation, the law implements a regulated mechanism for safeguarding documents and data related to innovative medical products, including those with new active ingredients.
The Emirates Drug Establishment is authorized to develop and the UAE Pharmacopeia, approve reference pharmacopeias, and issue guidelines for good practices aligned with international standards.
Marketing Authorisations and Fast-Track Approvals
Clear conditions are established for granting marketing authorisations, including exclusive, conditional, and emergency use authorisations. The law introduces a fast-track approval process for innovative and high-priority medical products, ensuring compliance with global quality, safety, and efficacy standards.
Management and Manufacturing
The legislation covers all aspects of managing medical products, including development, registration, pricing, import, export, marketing, sale, use, and safe disposal. It aligns with international good practice guidelines and permits the transfer of excipients and solvents between licensed manufacturing facilities within the UAE, subject to regulatory approval.
The law also governs the advertising, promotion, import, export, and re-export of medical products under the supervision of the Emirates Drug Establishment.
Pricing and Committees
The law defines pricing regulations for medical products and establishes the "Pharmaceutical Policies Committee" under the Chairperson of the Board of Directors of the Emirates Drug Establishment.
Licensing and Duties of Pharmacists
Pharmacists in the UAE must obtain licenses from the Ministry of Health and Prevention or the relevant local health authority. The law specifies their responsibilities and authorises clinical pharmacists to perform specific activities.
Pharmacovigilance and Databases
The Decree-Law establishes a pharmacovigilance system to ensure the safe use of medical products and mitigate adverse effects. It also provides for the creation of national databases for medical products, pharmaceutical facilities, and biobanks.
Penalties and Grace Period
Violations may result in disciplinary actions, including written warnings and fines ranging from AED 1,000 to AED 1 million for establishments and biobanks, and up to AED 500,000 for pharmacy practitioners. Severe breaches could lead to temporary license suspension or revocation.
Entities and individuals have a one-year grace period to comply with the law’s provisions, with the possibility of an extension through a Cabinet decision.
The law seeks to position the UAE as a globally trusted hub for pharmaceutical and medical industries, enhance pharmaceutical security, and streamline processes for developing, approving, manufacturing, marketing, and distributing medical products, all while adhering to international standards with competitive costs and timelines.
Scope and Applicability
The Decree-Law applies to a wide range of medical products, including drugs, medical devices, healthcare products, biological products, dietary supplements, cosmetics, and genetically modified organism products for medical use. It also governs chemical precursors, controlled substances, semi-controlled substances, and hazardous or toxic materials used in human and veterinary medicine.
Additionally, the law regulates all pharmaceutical establishments and biobanks within the UAE, including those in free zones. This includes pharmacies, pharmacy chains, compounding pharmacies, medical warehouses, manufacturing facilities, marketing firms, research entities, bioequivalence centers, biobanks, and other establishments designated by the UAE Cabinet. Practitioners of the pharmacy profession across the UAE are also subject to the law.
Regulatory Provisions
The Decree-Law outlines requirements for licensing, monitoring, and supervising pharmaceutical establishments and biobanks. It addresses ownership transfers, temporary suspensions, precautionary closures, and license revocations. Specific roles and responsibilities are assigned to the Emirates Drug Establishment, the Ministry of Health and Prevention, and local health authorities.
Pharmaceutical manufacturing facilities, marketing firms, and laboratories fall under the purview of the Emirates Drug Establishment, while biobanks and research entities are overseen by either the Emirates Drug Establishment or local health authorities. Pharmacies and storage facilities within government health centers are regulated by the Ministry of Health or local authorities.
Investment and Innovation
The law encourages investment in the pharmaceutical sector by introducing an incentive framework to attract investors and foster innovation. This framework will be established by the Cabinet based on recommendations from the Emirates Drug Establishment in collaboration with health authorities and stakeholders.
To protect innovation, the law implements a regulated mechanism for safeguarding documents and data related to innovative medical products, including those with new active ingredients.
The Emirates Drug Establishment is authorized to develop and the UAE Pharmacopeia, approve reference pharmacopeias, and issue guidelines for good practices aligned with international standards.
Marketing Authorisations and Fast-Track Approvals
Clear conditions are established for granting marketing authorisations, including exclusive, conditional, and emergency use authorisations. The law introduces a fast-track approval process for innovative and high-priority medical products, ensuring compliance with global quality, safety, and efficacy standards.
Management and Manufacturing
The legislation covers all aspects of managing medical products, including development, registration, pricing, import, export, marketing, sale, use, and safe disposal. It aligns with international good practice guidelines and permits the transfer of excipients and solvents between licensed manufacturing facilities within the UAE, subject to regulatory approval.
The law also governs the advertising, promotion, import, export, and re-export of medical products under the supervision of the Emirates Drug Establishment.
Pricing and Committees
The law defines pricing regulations for medical products and establishes the "Pharmaceutical Policies Committee" under the Chairperson of the Board of Directors of the Emirates Drug Establishment.
Licensing and Duties of Pharmacists
Pharmacists in the UAE must obtain licenses from the Ministry of Health and Prevention or the relevant local health authority. The law specifies their responsibilities and authorises clinical pharmacists to perform specific activities.
Pharmacovigilance and Databases
The Decree-Law establishes a pharmacovigilance system to ensure the safe use of medical products and mitigate adverse effects. It also provides for the creation of national databases for medical products, pharmaceutical facilities, and biobanks.
Penalties and Grace Period
Violations may result in disciplinary actions, including written warnings and fines ranging from AED 1,000 to AED 1 million for establishments and biobanks, and up to AED 500,000 for pharmacy practitioners. Severe breaches could lead to temporary license suspension or revocation.
Entities and individuals have a one-year grace period to comply with the law’s provisions, with the possibility of an extension through a Cabinet decision.