Tajikistan Medical Device Registration: Power of Attorney and the Legalization Chain

1. Key takeaways

In registration submissions to Tajikistan, making foreign documents legally effective is a step that cannot be skipped. Article 17(2) of Law No. 1893 defines the applicant as the manufacturer or its authorized person, which provides the legal foundation for an authorization mechanism; however, the provision itself does not specify the format of the power of attorney or the notarization and legalization requirements. The GRZAN guiding principle is that the law only opens the authorization pathway; format and authentication requirements must be found in the procedural documents of the Ministry of Health, and the full chain of notarization, legalization and translation must be prepared. As an additional note, Article 26(3)(3) lists foreign manufacturers of medicines and medical products and their authorized persons among the entities entitled to conduct import and export activities, which corroborates the authorized person mechanism at the statutory level.

2. Legal basis

3. Expert insights

Insight 1: Article 17(2) equates the applicant with the authorized person in parentheses, which establishes the legality of authorization as a matter of drafting technique. The text reads the manufacturer or its authorized person (the applicant), and the parenthetical functions as a definition: the legal content of the concept of applicant is precisely the manufacturer or its authorized person. The GRZAN interpretation is that a foreign manufacturer submitting through an authorized person rather than in person is a method expressly recognized by law, requiring no additional justification in the dossier.

Insight 2: Article 26(3)(3) gives the authorized person an independent position in import and export activities. The provision lists foreign manufacturers and their authorized persons among entities entitled to conduct import and export, for purposes including expert review, state registration, clinical trials and participation in scientific and political activities. The value of this clause is that it confirms the authorized person may handle import and export for registration purposes in its own name, without every act being performed in the name of the manufacturer. For sample submissions and the entry of test samples into the country, this provision is a key legal anchor.

Insight 3: Article 39(4) reveals that access for foreign entities is conditional. The provision allows foreign legal entities and natural persons to enter the Tajik pharmaceutical system under procedures determined by the Ministry of Health, unless otherwise provided by international treaties. This clause addresses professional qualification for pharmaceutical activities and is not identical to the authorized person for registration submissions, but both reflect the same logic: the legal position of foreign entities in Tajikistan is typically specified in procedural documents issued by the Ministry of Health rather than granted directly by the law. This further confirms the necessity of requesting the current procedural documents before designing the authorization package.

Insight 4: The scope of powers in the power of attorney should map one-to-one onto the full process chain. When designing the list of powers, GRZAN enumerates them article by article: registration submission under Article 17, amendments and re-registration under Article 17(10) and 17(12), import and export under Article 26, pharmacovigilance reporting under Article 20, and applications for cancellation or restriction of circulation under Article 21(4). The purpose of this design is to ensure the authorized person holds explicit authority at every subsequent stage, avoiding the need to execute a new power of attorney mid-process when an unexpected procedural step arises.

Insight 5: The separation of responsibility from authorization is the greatest risk point at this stage. Article 17(6) assigns responsibility for quality, effectiveness and safety to the registration certificate holder, while Article 17(2) permits submission through an authorized person. If a company registers the certificate in the name of the local authorized person, statutory responsibility shifts accordingly. The GRZAN recommendation is that the scope of authorization and the certificate-holding entity be designed together in a single legal instrument and never handled separately, with an internal indemnification mechanism documented alongside.

4. Practical recommendations

1. Enumerate the powers in the power of attorney item by item across the full process chain. Recommended coverage includes registration submission, document signing, receipt of official correspondence, handling of deficiency requests, amendments and re-registration, import and export procedures, pharmacovigilance reporting, and cancellation and restriction-of-circulation applications.
2. Prepare documents along the full chain of notarization, legalization and translation. The GRZAN standard sequence is: notarization in China, authentication by the Ministry of Foreign Affairs, legalization by the Tajik embassy or consulate in China, then translation into Tajik or Russian. Retain evidence of each step, and bind the translation together with the original as one integrated document.
3. Confirm the power of attorney format requirements with the supervisory authority before filing. Under Article 17(12), the format may be prescribed by Ministry of Health procedural documents. Request the current template or written confirmation of the requirements before submission.
4. Design the certificate-holding entity and the scope of authorization in the same instrument. Under Article 17(6), determine the authorization scope at the same time as the certificate-holding decision, and record an internal indemnification mechanism in the internal agreement.
5. Secure import and export powers for the authorized person under Article 26(3)(3). Where the authorized person must import samples in its own name, expressly list this purpose in the power of attorney and prepare the corresponding explanatory documents.

5. Verification checklist

• □ The submitting entity is confirmed as the manufacturer or its authorized person (Article 17(2))
• □ Authorization powers are enumerated item by item across registration, amendments, re-registration, import and export, vigilance reporting and cancellation
• □ The full chain of notarization, legalization and translation is completed with evidence retained at each step
• □ The power of attorney format requirements have been confirmed with the supervisory authority (Article 17(12))
• □ The authorization scope was determined together with the certificate-holding entity, with an internal indemnification mechanism agreed (Article 17(6))
• □ Explanatory documents for the import and export powers of the authorized person under Article 26(3)(3) have been prepared
• □ The eligibility of the authorized person is confirmed to meet the requirements of Ministry of Health procedural documents

Regulatory information verified as of October 29, 2026.

In the Central Asian market, GRZAN focuses its core capabilities on three areas. First, distinguishing the different legal positions of each market within the Eurasian Economic Union: Kazakhstan and Kyrgyzstan are full member states where a national track and a Union track coexist; Uzbekistan is an observer state with only the national track; Tajikistan and Turkmenistan lie outside the Union framework and must proceed entirely under national procedures. Second, local authorized representative services: GRZAN acts as the statutory representative of manufacturers in these countries, undertaking registration submission, regulatory communication and post-market reporting obligations. Third, quality system and testing support: GRZAN helps establish a quality management system compliant with ISO 13485 and connects clients with locally accredited laboratory resources.

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