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Pharmacovigilance in Tajikistan in 2026: MAH Requirements

Pharmacovigilance in Tajikistan in 2026: MAH Requirements

Updated 15 July 2026.

Pharmacovigilance in Tajikistan is governed by national medicinal product legislation. The principal current statute is Law of the Republic of Tajikistan No. 1893 of 19 July 2022 on Medicines, Medical Goods and Pharmaceutical Activity. It covers state regulation of medicinal product circulation, quality, efficacy and safety oversight, and the duties of pharmaceutical-sector participants.

Pharmacovigilance in Tajikistan: medicinal product safety oversight and MAH requirements
Medicinal product safety monitoring in Tajikistan.

Regulatory framework

The Ministry of Health and Social Protection of the Population develops national healthcare policy. Pharmaceutical registration, quality and safety are supervised by the authorised state structure responsible for expertise and control of pharmaceutical products.

Tajikistan is not an EAEU Member State, so EAEU pharmacovigilance rules do not apply automatically. International guidance may support company procedures, but national law, product authorisation conditions and formal authority requirements remain controlling.

Company responsibilities

  • maintain channels for receiving and documenting adverse reactions and other safety issues;
  • validate minimum case data, medically assess reports and obtain follow-up information;
  • submit safety reports to the competent authority in the applicable format and national timelines;
  • monitor literature, regulatory decisions and changes in the benefit–risk profile;
  • confirm product-specific requirements for periodic reports, risk management plans and risk-minimisation measures;
  • appoint responsible personnel, train staff, oversee partners and retain documentation.

MAH readiness checklist

  1. Verify current legislation and product-specific authorisation commitments.
  2. Appoint primary and back-up pharmacovigilance contacts.
  3. Maintain procedures for ICSR handling, deadlines, literature, signals and records.
  4. Define safety-data exchange in agreements with distributors and partners.
  5. Perform quality reviews and maintain regulatory inspection readiness.

Official sources

How PharmExpert can help

PharmExpert supports local pharmacovigilance in Tajikistan through regulatory gap assessments, case processing, procedures and partner agreements, compliance tracking and inspection readiness.

This article is for general information. Applicable formats and timelines should be confirmed against current legislation and product-specific authorisation conditions.