Pharmacovigilance in Azerbaijan in 2026: MAH Requirements

Updated 15 July 2026. Azerbaijan’s pharmacovigilance system is governed by national legislation and overseen by the Ministry of Health and its Analytical Expertise Center (AEM/AEC). Azerbaijan is not a member or observer state of the Eurasian Economic Union, so EAEU pharmacovigilance rules do not automatically apply to Azerbaijani marketing authorisations.

Marketing authorisation holders (MAHs) should maintain a locally compliant pharmacovigilance system, appoint an accessible responsible person, submit safety information within applicable timelines, and remain ready for regulatory assessment and inspection.

Authority and legal framework

The competent authority is the Analytical Expertise Center of the Ministry of Health of the Republic of Azerbaijan. Its pharmacovigilance unit receives and evaluates suspected adverse reaction reports, assesses emerging risks, and supports risk-minimisation measures.

• Cabinet of Ministers Resolution No. 503 of 25 December 2019 approved the Regulation on Pharmacovigilance of Medicinal Products.
• The national Good Pharmacovigilance Practice guideline sets expectations for system organisation, quality processes and stakeholder responsibilities.
• MAHs should also follow current medicines legislation and official AEM/AEC communications.

Core MAH pharmacovigilance requirements

1. Responsible pharmacovigilance person

The MAH should ensure that a suitably qualified and reachable pharmacovigilance contact is in place. This person coordinates local activities, communicates with AEM/AEC, oversees case processing, aggregate reporting, signal management and corrective actions. Contact and back-up arrangements must remain current.

2. Pharmacovigilance system and PSMF

The system must be documented and operational. The Pharmacovigilance System Master File (PSMF) should describe governance, products, safety-data sources, databases, agreements, procedures, quality indicators, training, audits and CAPA. It should be updated promptly after material organisational or regulatory changes.

3. Individual case safety reports

MAHs need processes for intake, validation, medical review, follow-up and submission of suspected adverse reaction reports within the applicable timelines. Sources may include healthcare professionals, patients, literature, studies, support programmes, partners and digital channels. The precise deadline depends on the case category and current requirement and should be defined in the local procedure.

4. Literature and regulatory monitoring

The monitoring frequency must support timely reporting and identification of new safety information. A universal weekly frequency should not be claimed without a product-specific legal or procedural basis. Search scope, languages, databases, screening criteria and quality control should be documented.

5. PSURs, RMPs and signal management

Periodic safety reports should follow the applicable schedule and reference dates. AEM/AEC refers MAHs to the EU Reference Dates list, the first Azerbaijani registration date or the international birth date, depending on the relevant situation. Risk Management Plans should reflect current risks and minimisation measures. Safety signals must be detected, assessed, documented and escalated without delay.

How to report a suspected adverse reaction

AEM/AEC accepts reports from healthcare professionals and patients through official forms and reporting channels, including an online reporting route connected with the WHO international medicines monitoring programme. A mobile application is also available for reporting suspected medicine adverse reactions and adverse events following immunisation.

• description and timing of the reaction;
• suspected medicine, dose and treatment schedule;
• patient age and sex without unnecessary personal data;
• concomitant conditions and medicines;
• reporter contact details for follow-up.

Submitting a safety report does not replace medical care. For a life-threatening condition, contact emergency medical services.

Partner oversight and inspection readiness

1. Verify local pharmacovigilance contacts and back-up coverage.
2. Update the PSMF, SOPs and registered-product list.
3. Review safety agreements with distributors, medical representatives and vendors.
4. Reconcile safety cases and investigate overdue submissions.
5. Confirm PSUR schedules, RMP status and open signals.
6. Review safety-database validation, access control and audit trails.
7. Document training, deviations, CAPA and internal audits.

Conclusion

Pharmacovigilance in Azerbaijan in 2026 requires a distinct national compliance model, not automatic application of EAEU rules. The practical priorities for MAHs are an accessible responsible person, a documented system, timely ICSRs and aggregate reports, signal and risk management, partner oversight and continuous inspection readiness.

PharmExpert supports MAHs in Azerbaijan with local responsible-person services, PSMF maintenance, literature and regulatory monitoring, case processing, PSURs, RMPs, signal management, audits and inspection preparation.

Official sources

1. AEM/AEC pharmacovigilance section.
2. Cabinet of Ministers Resolution No. 503: Regulation on Pharmacovigilance.
3. AEM/AEC information for healthcare professionals.
4. AEM/AEC information for patients.
5. AEM/AEC information for MAHs on PSURs.

This article provides general information only. Before taking a regulatory action, check the current legislation and the latest official AEM/AEC guidance.