Tajikistan Pharmaceutical Activity Licensing and Staff Qualifications for Medical Device Companies

1. Key takeaways

Tajikistan applies dual management of licensing and qualifications to pharmaceutical activity involving medicines and medical devices. Article 38 of Law No. 1893 provides that licensing of pharmaceutical activity is implemented in accordance with the Licensing Law of the Republic of Tajikistan; Article 39 sets out the education and certificate requirements for practitioners; and Article 40(3) imposes a clear requirement on the heads of organisations – the head of an organisation engaged in the production, wholesale sale, importation or exportation of medicines, medical devices and parapharmaceuticals must have a higher professional pharmaceutical education. GRZAN notes that Article 40(3) is the requirement most easily overlooked by foreign investors entering Tajikistan.

2. Legal basis

3. Expert insights

Insight 1: Article 40(3) is a substantive threshold for foreign investors. The provision requires that the head of an organisation engaged in the production, wholesale sale, importation or exportation of medicines, medical devices and parapharmaceuticals must have a higher professional pharmaceutical education. The implication is that if a Chinese manufacturer establishes a subsidiary in Tajikistan to conduct these activities, its general manager or head must hold a pharmaceutical degree of bachelor level or above. GRZAN recommends completing the staffing plan before establishing the entity rather than adjusting afterwards.

Insight 2: Article 38 points the licensing basis to the Licensing Law rather than to Law No. 1893 itself. The provision states that licensing of pharmaceutical activity is implemented in accordance with the Licensing Law. The implication is that the specific conditions, procedures, duration and fees of the licence must be found in the Licensing Law; Law No. 1893 only settles the question of whether a licence is required. GRZAN recommends obtaining the current text of the Licensing Law and using it in combination with Article 9(1) (the supervisory authority implements licensing).

Insight 3: Article 1(12) includes state registration within the definition of pharmaceutical activity. The provision defines pharmaceutical activity as a broad concept covering development, production, manufacturing, storage, packaging, transport, state registration, standardisation and quality control, labelling, trade, advertising, use and more. The consequence is that carrying out state registration may itself constitute pharmaceutical activity, and may therefore require the licence of Article 38. GRZAN notes that the direct impact of this reading on foreign manufacturers is not yet clear, but it should be included in the assessment when designing the local structure.

Insight 4: The rule of Article 39(5) on more than 3 years without practice is a hidden constraint on staffing. The provision requires pharmaceutical workers whose practice has been interrupted for more than 3 years to complete an internship and confirm their qualification before resuming. For personnel who have worked at the Chinese headquarters for many years and are planned for secondment to Tajikistan, an interruption in the professional post as recognised by the Tajik side may require the internship and qualification confirmation procedure again. GRZAN recommends reserving time for this in the secondment plan.

Insight 5: Article 39(4) opens a channel for foreign subjects, but adds the caveat unless otherwise provided by international agreements. The provision allows foreign legal entities and natural persons to enter the pharmaceutical system of Tajikistan in accordance with the procedure determined by the Ministry of Health, with international agreements taking precedence where applicable. GRZAN recommends confirming first whether a relevant bilateral agreement exists between China and Tajikistan before deciding which pathway applies to the recognition of foreign qualifications.

4. Practical recommendations

1. Complete the staffing plan for Article 40(3) before establishing the entity. When establishing an entity in Tajikistan for production, wholesale or import-export activities, treat a head with higher professional pharmaceutical education as a hard recruitment condition and reflect it in the company charter and appointment documents.
2. Obtain the current text of the Licensing Law. Under Article 38, request the Licensing Law from the competent authority and combine it with Article 9(1) to confirm the licence conditions, procedures and document lists.
3. Assess whether state registration triggers the pharmaceutical activity licence. Under Article 1(12), evaluate at the structure design stage whether the registration activity falls within pharmaceutical activity and decide accordingly whether the licence of Article 38 is needed.
4. Reserve internship and qualification confirmation time under Article 39(5) in the secondment plan. For secondees with a pharmaceutical background, check the length of any interruption of practice; where it exceeds 3 years, reserve the internship and confirmation stages in the schedule.
5. Check for bilateral agreements between China and Tajikistan. Under Article 39(4), confirm the bilateral arrangements on qualification recognition first, then decide between the foreign subject channel and the agreement channel.

5. Verification checklist

• □ Confirmed that the licensing basis of Article 38 is the Licensing Law
• □ Confirmed that Article 40(3) requires the head of production, wholesale and import-export organisations to hold higher professional pharmaceutical education
• □ Obtained the current text of the Licensing Law and combined it with Article 9(1)
• □ Assessed whether state registration triggers the pharmaceutical activity licence under Article 1(12)
• □ Checked the interruption of practice of planned secondees and reserved the internship and confirmation stages of Article 39(5)
• □ Checked the status of bilateral agreements on qualification recognition between China and Tajikistan (Article 39(4))
• □ Obtained the practice procedure documents determined by the Ministry of Health under Article 39(2) and (4)

Regulatory information verified as of October 29, 2026.

In the Central Asian market, the core capabilities of GRZAN focus on three points. First, distinguishing the different legal positions of each market within the Eurasian Economic Union: Kazakhstan and Kyrgyzstan are full member states where a choice exists between a national pathway and a Union pathway; Uzbekistan is an observer state with only a national pathway; Tajikistan and Turkmenistan are outside the Union framework and must follow purely national procedures. Second, local authorised representative services: GRZAN can act as the statutory representative of manufacturers in the above countries, undertaking registration submission, regulatory communication and post-market reporting obligations. Third, quality system and testing support: GRZAN assists in establishing a quality management system conforming to ISO 13485 and connects clients with locally accredited laboratory resources.

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