Additional marketing agent feature introduced by Emirates Drug Agency
Emirates Drug Agency recently convened a virtual stakeholders council to introduce an additional marketing agent feature aimed at streamlining approvals for medical devices. The online meeting gathered representatives from pharmaceutical establishments, medical warehouses, marketing offices and local manufacturer agents to review the mechanism and practical steps for activation.
The agency said the session focused on clarifying requirements for the new feature within marketing approvals, explaining how marketing authorization holders can appoint a secondary partner to import and distribute medical devices across the UAE market. Officials indicated the initiative is intended to improve supply flexibility and reduce the risk of shortages.
Additional marketing agent feature explained
According to the agency, the additional marketing agent option allows a marketing authorization holder to designate more than one licensed pharmaceutical establishment to handle import and distribution of approved medical devices. This measure lets owners of marketing rights diversify distribution channels while maintaining regulatory oversight. Furthermore, the feature includes defined documentation, verification checks and an activation workflow to ensure traceability and accountability.
Officials said the activation process requires submission of an addendum to the original marketing approvals, signed agreements between the marketing authorization holder and the designated establishments, and confirmation of compliance with licensing and storage standards. In addition, the agency outlined timelines for processing requests and highlighted digital validation steps designed to accelerate approvals and minimize administrative delays.
Stakeholder feedback and operational considerations
Stakeholders participated actively, providing practical input on how the additional marketing agent facility will operate in daily workflows. Representatives of local manufacturer agents, medical warehouses and marketing offices shared concerns and suggestions about contract templates, liability allocation, and interoperability with existing inventory and tracking systems. These contributions, the agency said, will inform refinements to guidance documents and user interfaces.
Meanwhile, attendees discussed how to align the new feature with existing supply arrangements and international distribution agreements. Participants emphasized the need for clear roles and responsibilities, especially for cold chain products and high-risk devices. Therefore, the agency pledged to issue operational clarifications and step-by-step instructions for applicants who wish to use the additional marketing agent option.
Impact on medical devices supply chain and marketing approvals
Regulators and industry observers noted the feature could bolster supply chain resilience by enabling alternative import routes and multiple distribution partners. Consequently, this can lessen the chance of market disruptions when a single distributor faces logistical issues. In addition, the move is expected to ease access to specialized equipment in remote or high-demand settings by broadening distribution networks.
From a regulatory perspective, the agency said the additional marketing agent arrangement will be integrated into the marketing approvals workflow to preserve oversight while granting operational flexibility. Marketing approvals will record all authorized importers and distributors, and inspection protocols will account for multiple-party responsibilities. Therefore, the change aims to balance public health safeguards with improved commercial adaptability.
Regulatory context and legal alignment
The new mechanism comes under the provisions of Federal Decree-Law No. 38 of 2024 on Medical Products, the Pharmacy Profession and Pharmaceutical Establishments, which established updated frameworks for marketing rights, importation and distribution. Officials explained that implementing the additional marketing agent tool aligns with the law’s intent to modernize regulatory controls and codify marketing and distribution rights.
In practice, the agency will update its guidance and online portals to reflect statutory provisions and to provide templates and checklists for applicants. According to the agency, these updates will clarify how existing marketing authorization holders can comply with the law while taking advantage of expanded distribution options enabled by the additional marketing agent feature.
Benefits, risks and safeguards
Observers said the clear benefits include diversified supply channels and reduced vulnerability to single-point failures within the distribution network. Furthermore, healthcare providers may see improved continuity of supply for essential devices, which supports patient care. However, stakeholders also stressed the importance of robust recordkeeping, contractual clarity and regulatory supervision to prevent unauthorized distribution or gaps in product traceability.
To mitigate risk, the agency plans to require documented agreements, licensing verification and periodic reporting from designated pharmaceutical establishments. Inspections and electronic tracking will remain part of the compliance regime, officials added, ensuring that the additional marketing agent approach does not dilute product safety or quality oversight.
Next steps and what to watch
The agency indicated that revised guidance and technical updates to the electronic approvals platform will be published within the coming weeks, accompanied by user instructions and example forms. Meanwhile, stakeholders were invited to submit further recommendations through established consultation channels so that implementation can reflect operational realities across the sector.
Readers should watch for the agency’s formal guidance release and the rollout timeline for portal updates, which will signal when marketing authorization holders can start submitting applications to designate an additional marketing agent. In the short term, industry participants can prepare by reviewing existing contracts, ensuring licensing compliance for potential partners and aligning internal processes with the forthcoming requirements.