Up To Dh1 Million Penalty: What Does The New UAE Federal Decree-Law On Pharmaceutical Sector Entail
The UAE has enacted a comprehensive Federal Decree-Law aimed at regulating the pharmaceutical sector, covering the entire spectrum from the pharmacy profession to medical products and pharmaceutical establishments.
This newly introduced law mandates the regulation, licensing, and supervision of all pharmaceutical establishments and biobanks across the nation, including those in free zones. The scope of the Decree-Law is extensive, encompassing drug products, medical devices, and various other health-related products intended for both human and veterinary use.
It is designed to regulate a wide range of entities, from pharmacies and laboratory facilities to manufacturing, storage, and marketing firms, ensuring they operate in compliance with the defined legal framework.
This legislation represents a significant stride toward reinforcing the UAE's standing as a globally recognized center for pharmaceutical and medical industries. It seeks to bolster pharmaceutical security and streamline the processes involved in the development, approval, manufacturing, marketing, and distribution of medical products. These efforts are to be undertaken while adhering to international standards, yet ensuring competitive costs and timelines.
Under the new law, the Emirates Drug Establishment, alongside the Ministry of Health and Prevention and local health authorities, is tasked with the crucial roles of monitoring and supervising the vast array of pharmaceutical establishments and biobanks. This includes the oversight of licencing processes, ownership transfers, and, if necessary, the implementation of temporary suspensions or licence revocations. Furthermore, the Decree-Law extends to practitioners within the pharmacy profession, ensuring they are properly licensed to operate within the UAE.
The law introduces an incentive framework aimed at attracting investments into the pharmaceutical sector, fostering an environment conducive to innovation and development. This framework is to be established by a Cabinet decision, formulated based on a proposal from the Chairman of the Emirates Drug Establishment in collaboration with health authorities and stakeholders. This initiative underscores the UAE's commitment to nurturing growth and advancement within the medical industries.
In a move to safeguard innovation, the Decree-Law implements mechanisms for the protection of documents and data pertaining to innovative medical products. This includes products that feature at least one new active ingredient, whether they are produced domestically or imported. Additionally, for the first time, the Emirates Drug Establishment is empowered to develop and maintain the UAE Pharmacopeia, approve reference pharmacopeias, and set forth guidelines and standards for good practices that resonate with internationally acknowledged principles.
The legislation outlines clear criteria for granting marketing authorisations for medical products, introducing a fast-track approval pathway for innovative and therapeutically significant medical products. It ensures that these products meet global standards for quality, safety, and efficacy, thereby regulating every aspect of medical product management from development to safe disposal.
The Decree-Law encompasses provisions for the development and manufacturing of medical products in alignment with good practice guidelines and international standards. It allows for the transfer of excipients and solvents between licenced manufacturing facilities within the UAE, subject to the approval of the Emirates Drug Establishment. Additionally, it regulates the advertising, promotion, import, export, and re-export of medical products under the supervision of the said Establishment.
Entities and individuals subject to this law are given a one-year grace period to ensure compliance, with the possibility of an extension through a Cabinet decision. The Decree-Law prescribes disciplinary actions, including financial penalties ranging from Dh1,000 to Dh1 million for pharmaceutical establishments and biobanks, and up to Dh500,000 for pharmacy profession practitioners, for violations. More severe breaches could lead to temporary suspension or revocation of licences.
Significantly, the legislation introduces regulations for the pharmacovigilance system in the UAE, aiming to ensure the safe usage of medical products and to minimize side effects and adverse reactions. It also mandates the establishment and management of national databases for medical products, pharmaceutical facilities, and biobanks, enhancing the regulatory framework within the country.
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