Tajikistan Medical Device Labelling and Packaging: Unified Requirements

1. Key takeaways

Tajikistan applies unified requirements to the labelling and packaging of medicines, medical products and quasi-medicinal products, with the specific specifications developed and approved by the authorized state body in the healthcare sector. Article 43 of Law No. 1893 provides two things: first, the Republic of Tajikistan establishes unified requirements for the labelling and packaging of medicines, medical products and quasi-medicinal products; second, the development and approval of labelling and packaging requirements is the responsibility of the authorized state body in the healthcare sector. GRZAN notes that Article 43 contains only two paragraphs and the statutory level does not set out the specific content elements of a label; in practice, companies must request the currently valid labelling and packaging specification documents of the Ministry of Health. As for the claim circulating online that a bilingual label format was prescribed by Ministry of Health Order No. 215, we do not adopt it, as no official source has been verified.

2. Legal basis

3. Expert insights

Insight 1: The two-paragraph structure of Article 43 shows that label specifications belong to lower-tier, adjustable documents. Paragraph 1 establishes the principle of unified requirements, and paragraph 2 assigns the development and approval power to the Ministry of Health. The GRZAN interpretation is that Tajikistan has no statutory-level checklist of label elements; all specific requirements sit in Ministry of Health documents. Two practical consequences follow: the currently valid documents must be requested, and because label specifications may be adjusted, the labels of products already on the market may need corresponding updates.

Insight 2: Article 1(21) defines the instructions for use as an approved document, which is the key point. The provision states that the instructions for use are a document approved under the procedure determined by the Ministry of Health. The implication is that the instructions are not a leaflet printed at the manufacturer’s discretion but one of the objects of the registration approval. This connects with Article 45(6), under which advertising texts must conform to the instructions, and with Article 21(1)(6) and (7), under which unstated dangerous side effects or a rise in stated serious side effects constitute withdrawal grounds: the instructions are both an approval object and the benchmark for subsequent liability determinations.

Insight 3: The packaging definition of Article 1(16) includes environmental protection requirements. The provision defines packaging as a means or combination of means that protects the circulation process by preventing damage and loss, and that prevents environmental pollution. This wording brings the environmental dimension into the legal definition of packaging. GRZAN notes that when preparing packaging material descriptions, companies should address, beyond protective performance, the environmental impact and disposal of the materials, especially for products containing mercury, batteries or latex and other sensitive materials.

Insight 4: Article 45(7)(2) excludes labels and instructions for use from the category of advertising. The provision lists five situations that do not constitute advertising, the second of which is labels and instructions for use. The technical meaning of this exclusion is that the information on labels and instructions does not need to pass the advertising approval procedure of Article 45(2); conversely, however, it must satisfy the unified requirements of Article 43 and the approval procedure of Article 1(21). When preparing these documents, companies should follow the registration approval channel rather than the advertising approval channel.

Insight 5: Article 21(1)(6) and (7) convert defects in instruction content directly into withdrawal grounds. Item 6 covers the detection of dangerous side effects not stated in the instructions, and item 7 covers an increase in cases of serious side effects already stated. The common thread is that the accuracy and completeness of the instructions are a precondition for the product to remain in circulation. GRZAN recommends making instruction updates a standing post-market compliance task: whenever new risk information emerges globally, assess whether the Tajik instructions need a synchronized update.

4. Practical recommendations

1. Request the currently valid labelling and packaging specification documents. Under Article 43(2), request the current specifications from the Ministry of Health as the sole basis for label design, and retain the version information on record.
2. Prepare the instructions for use as an approval object. Under Article 1(21), the instructions must be approved under the procedure determined by the Ministry of Health. Compile the instructions as a separate volume in the submission and reserve time for approval communications.
3. Add the environmental dimension to packaging material descriptions. Under Article 1(16), supplement the descriptions with material composition, recyclability and disposal methods, and provide separate statements for products containing mercury, batteries or latex.
4. Follow the registration approval channel, not the advertising approval channel. Under Article 45(7)(2), labels and instructions do not constitute advertising and need no advertising approval, but they must meet the unified requirements of Article 43 and the approval procedure of Article 1(21).
5. Establish a global synchronized update mechanism for the instructions. Under Article 21(1)(6) and (7), when new risk information emerges globally, assess whether the Tajik instructions require a synchronized update, and file the corresponding change under Article 17(12).

5. Verification checklist

• □ The currently valid labelling and packaging specification documents have been obtained with versions retained (Article 43(2))
• □ The instructions for use have been compiled and submitted as a separate approval object (Article 1(21))
• □ Environmental dimension information has been added to the packaging material descriptions (Article 1(16))
• □ It has been confirmed that labels and instructions follow the registration approval channel, not the advertising channel (Article 45(7)(2))
• □ A global synchronized update mechanism for the instructions has been established (Article 21(1)(6) and (7))
• □ Label content has been confirmed to meet the unified requirements of Article 43(1)
• □ Consistency between advertising texts and the instructions has been confirmed (Article 45(6), where advertising is involved)

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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