Emergency & Special Access Pathways for Pharmaceuticals A comprehensive guide to emergency, compassionate, and special-access frameworks across the Middle East and Latin America

Navigating Emergency Access Markets Our Focus This presentation maps country-specific emergency and compassionate-use pathways that enable pharmaceutical access when standard registration isn't feasible. We examine regulatory frameworks across 11 key markets in the Middle East and Latin America. Each pathway represents an opportunity to deliver critical medicines through structured, compliant channels. Success Framework Emergency supply success requires three pillars working in harmony: Documentation: CPP, GMP, chain of custody Pathway knowledge: Country-specific regulations Execution readiness: Local partnerships and logistics When aligned, these elements unlock rapid market access for life-saving therapies.

Saudi Arabia SFDA Special Access Program Regulatory Authority Saudi Food and Drug Authority (SFDA) oversees all pharmaceutical imports and emergency access mechanisms in the Kingdom. Special Access Program The SAP pathway enables import of unregistered products when urgently required for patient care. This is the primary mechanism for emergency pharmaceutical access in Saudi Arabia. Import Requirements Valid import permit from SFDA Licensed local entity as importer of record Complete product documentation package Cold-chain validation for biologics Documentation Standards Saudi Arabia maintains high expectations for documentation completeness, chain of custody records, and temperature monitoring throughout the supply chain. GNH Execution Note: Success in Saudi Arabia demands strong local importer alignment from day one. The licensed entity must be established, compliant, and experienced with SFDA SAP protocols. Pre-qualify partners before committing to supply timelines.

United Arab Emirates MOHAP Emergency Use Framework Emergency Use Authorization The UAE's EUA framework provides structured access for unregistered products during urgent medical situations and public health emergencies. Named-Patient Permits Individual patient import permits available for personal use cases, requiring physician justification and patient-specific documentation. Bulk Emergency Supply Larger emergency volumes require pre-authorized channels through licensed importers with MOHAP approval. Not available through personal- use pathways. Controlled Medicines Products classified as controlled substances face additional approval layers and stricter documentation requirements across all pathways. GNH Execution Note: Critical distinction exists between single- patient vs. bulk emergency routes. Named-patient permits work for individual cases but cannot scale. Bulk supply requires advance channel authorization and licensed importer infrastructure.

Qatar Ministry of Public Health Import System Qatar operates a permit-driven import system with strong centralized control through the Ministry of Public Health and its Pharmacy and Drug Control Department. Key Requirements PDCD e-system: All import permits processed through digital platform Licensed importer mandatory: No direct imports allowed Pre-approval essential: Permits must be secured before shipment Enhanced controls: Biologics and controlled substances face heightened scrutiny GNH Execution Note: Qatar demands pre-approved importer relationships and documentation readiness before any supply commitment. The e-system is efficient but unforgiving of incomplete submissions. Ensure your local partner has active MOPH standing and PDCD system access.

Kuwait Ministry of Health Discretionary Approvals Regulatory Landscape Kuwait's Ministry of Health allows import of non-registered medicines under specific MOH approvals, but this pathway is highly dependent on individual case review and local agent influence. Unlike some neighbors, Kuwait lacks a standardized emergency access program with published criteria. Critical Success Factors Strong local agent with MOH relationships Case-by-case MOH discretion No guaranteed timelines or approval criteria Significant groundwork required before execution This is not a fast-track market without substantial preparation. GNH Execution Note: Exercise caution with volume commitments in Kuwait. The discretionary nature of approvals creates execution risk. Invest time in local agent qualification and MOH relationship-building before committing to supply agreements. Consider Kuwait for strategic, relationship-driven opportunities rather than urgent emergency supply.

Egypt Egyptian Drug Authority Emergency Use Authorization Egyptian Drug Authority The EDA serves as the national regulatory authority, with clear guidelines for emergency pharmaceutical access. Formal EUA Guideline Egypt has published a structured Emergency Use Authorization framework with defined criteria and application processes. Public Health Trigger The EUA pathway activates during declared public health emergencies, providing a clear legal basis for unregistered product access. Clear Pathway When criteria are met, Egypt offers one of the more transparent and predictable emergency access routes in the region. Egypt's population of over 100 million and established pharmaceutical sector make it a significant opportunity for emergency supply when public health conditions warrant EUA activation. GNH Execution Note: Position Egypt as one of the clearer EUA markets in the Middle East. The formal framework reduces ambiguity and creates a more predictable approval pathway compared to discretionary systems. Monitor public health declarations and maintain EDA relationships for rapid activation when opportunities arise.

Brazil ANVISA Special Access Mechanisms Expanded Access Programs Structured pathways for investigational products beyond clinical trials, allowing access to promising therapies before registration. Compassionate Use Individual patient access to unregistered medicines when no therapeutic alternative exists and patient faces serious or life- threatening condition. Post-Study Supply Continued access for clinical trial participants after study completion, ensuring treatment continuity for responders. Execution Reality All Brazilian special access pathways are sponsor-led and require substantial documentation, including: Comprehensive medical rationale Clinical evidence packages Manufacturing and quality documentation Patient consent and monitoring protocols Operational Requirements Brazil's continental scale and tropical climate demand excellence in: Cold-chain management: Validated temperature control Traceability: Complete chain of custody Review timelines: ANVISA processes require patience GNH Execution Note: Position Brazil as high-effort, high-scale. The documentation burden is significant, but the market opportunity is proportional. Success requires experienced local partners with ANVISA expertise and proven cold-chain infrastructure. Not suitable for urgent, small-volume emergency supply, but excellent for strategic, planned special access programs.

Mexico COFEPRIS Compassionate Use Pathway

1. Regulatory Authority The Federal Commission for Protection against Sanitary Risks (COFEPRIS) governs pharmaceutical imports and compassionate use approvals.
2. Compassionate Use Framework Mexico permits compassionate use of unregistered medicines through a formal import permit system. Medical justification and physician oversight are central to approvals.
3. Local Authorization Required All imports must flow through a locally authorized party. Direct imports by foreign entities are not permitted under compassionate use provisions.
4. Permit-First Approach Mexico follows a strict permit-first, product-second sequence. Shipments cannot proceed until COFEPRIS import authorization is secured. Mexico's proximity to the United States and large population make it strategically important for pharmaceutical access, but regulatory compliance cannot be shortcut. GNH Execution Note: Mexico demands advance permit planning. The permit-first sequence is non-negotiable, and COFEPRIS timelines vary. Build permit acquisition time into supply commitments. Partner with local authorized parties who have established COFEPRIS relationships and understand compassionate use documentation requirements.

Argentina, Colombia & Chile Three Distinct Emergency Access Models Argentina · ANMA T Named-Patient Import Pathway Argentina's system centers on compassionate and named-patient imports requiring strong physician justification. ANMAT reviews each case individually, focusing on medical necessity and absence of therapeutic alternatives. Individual patient focus, not bulk commercial supply Detailed clinical documentation mandatory Best suited for targeted emergency cases Colombia · INVIMA MVND: Vital Medicines Not Available Colombia's Medicamentos Vitales No Disponibles pathway is purpose-built for products registered elsewhere but unavailable locally. This creates a clear fit for emergency and shortage scenarios. Evidence of foreign registration required Demonstrates local unavailability of alternatives Strong, repeatable pathway for ongoing supply Chile · ISP Exceptional Use Authorization Chile's Institute of Public Health grants compassionate and exceptional use through resolution- based approvals. Each authorization is product- and case- specific. Resolution defines scope and volume limits Not designed for large commercial volumes Each resolution is situation- specific GNH Execution Notes: Argentina

1. Position for targeted cases with clear medical urgency. Colombia
2. Excellent repeatable pathway when foreign registration exists; invest in INVIMA relationships. Chile
3. Understand resolution- specific scope before committing; not suitable for bulk commercial supply without clear ISP authorization.

Peru DIGEMID Provisional Authorization Peru's General Directorate of Medicines, Supplies and Drugs (DIGEMID) offers provisional import and use authorization for products without full registration when defined conditions are met. Pathway Characteristics Medical justification mandatory: Clear clinical need must be demonstrated Individual or emergency focus: Designed for specific patient needs or emergency situations Provisional status: Authorizations are temporary and case-specific Limited scope: Not intended for ongoing commercial supply DIGEMID reviews each application on its merits, evaluating medical necessity, product safety documentation, and supply chain integrity. GNH Execution Note: Position Peru for rapid, limited deployments when medical need is clear and urgent. The provisional pathway works well for emergency situations with strong clinical justification. Partner with local entities experienced in DIGEMID procedures to minimize approval timelines.

GNH Emergency Supply Playbook Common Success Requirements Across All Markets Lawful Origin Product must be manufactured in facilities with proper regulatory standing and exported legally from country of origin. CPP & GMP Evidence Certificate of Pharmaceutical Product and Good Manufacturing Practice documentation required universally. Chain of Custody Complete traceability from manufacturer through distribution to final destination with temperature monitoring. Local Interface Licensed importer and regulator relationships essential in every market for compliant execution. Emergency access succeeds when documentation, pathway, and execution are aligned. Whether serving the Middle East or Latin America, these three pillars remain constant. Master them, and GNH can unlock emergency supply opportunities that deliver both commercial value and patient benefit across diverse regulatory landscapes.