Tajikistan Medical Device Advertising Approval and the Ban on Unregistered Products

1. Key takeaways

Tajikistan erects three gates in front of the advertising of medicines, medical devices and parapharmaceuticals: advertising of unregistered products is prohibited; advertising requires a licence from the Ministry of Health; and the advertising text must be agreed with the supervisory authority and must conform to the instructions for use. Article 45(1) of Law No. 1893 prohibits advertising of medicines, medical devices and parapharmaceuticals not registered in the Republic of Tajikistan; Article 45(2) requires a licence from the authorised state body in the field of health for advertising them; Article 45(6) requires the advertising text to be agreed with the supervisory authority and to conform to the instructions for use. GRZAN notes that Article 45 has 9 paragraphs, of which paragraph 7 lists 5 categories of information that do not constitute advertising – labelling and instructions for use are among them.

2. Legal basis

3. Expert insights

Insight 1: Article 45(8) is a notably more relaxed arrangement for medical devices compared with medicines. The provision allows advertising of medical devices and parapharmaceuticals in all publications in accordance with the procedure determined by the legislation; by contrast, paragraphs 3 and 4 draw a strict line for medicines – over-the-counter medicines may be advertised in mass media, while information on prescription medicines is confined to professional publications. GRZAN judges that the advertising channels for devices are significantly wider than for prescription medicines, but the three gates of paragraphs 1, 2 and 6 must still be cleared.

Insight 2: Article 45(1) sets lack of registration directly as a ground of the advertising ban, which is a hard constraint. The provision prohibits advertising of products not registered in Tajikistan. The implication is that a company cannot conduct advertising activities in any form before registration is completed. GRZAN notes that at exhibitions, in academic promotion and in digital marketing, a strict distinction must be drawn between advertising and the situations listed in Article 45(7) that do not constitute advertising.

Insight 3: The five exclusions of Article 45(7) are the operating space for compliant promotion. Among the five categories, the two most relevant for device companies are information provided to medical and pharmaceutical professionals and labelling and instructions for use. The implication is that technical exchanges addressed to professionals, product descriptions, labelling and instructions do not constitute advertising and do not require the licensing procedure of paragraph 2. GRZAN recommends managing these two categories separately from advertising in the marketing planning process.

Insight 4: The requirement of Article 45(6) that the advertising text conform to the instructions for use turns the instructions into the content boundary of advertising. The provision requires the advertising text to be agreed with the supervisory authority and to conform to the instructions for use. Combined with Article 21(1)(6) and (7) (dangerous side effects not stated in the instructions, or a serious increase in stated side effects, as grounds for market withdrawal), the structure is that the instructions for use are both the content boundary of advertising and the benchmark for the product’s continued existence. Companies should compare the advertising text sentence by sentence against the approved instructions.

Insight 5: Article 45(5) prohibits horizontal comparison in medicine advertising, but the wording refers to medicines. The provision prohibits comparing a medicine with other medicines to reinforce the advertising effect. Whether the same prohibition applies to devices needs confirmation. The conservative recommendation of GRZAN is that even though the provision does not expressly apply to devices, companies should avoid comparative claims in advertising to prevent being found in breach of fair competition or of the licence conditions of paragraph 2.

Insight 6: Article 45(9) points the liability for violating the advertising requirements to Tajik legislation. The provision states that violation of the advertising requirements of this article entails liability under the legislation of the Republic of Tajikistan. Combined with Article 48 (natural persons and legal entities bear liability for non-compliance with the requirements of the law under the legislation), the consequence of an advertising violation is a clear liability outcome, not merely a requirement of rectification.

4. Practical recommendations

1. Do not conduct any form of advertising before registration is completed. Under Article 45(1), suspend all advertising activities until the registration certificate is obtained; conduct market promotion through the professional exchange and instructions channels of Article 45(7)(1) and (2).
2. Obtain the Ministry of Health licence and agree the text with the supervisory authority before publication. Under Article 45(2) and (6), build a two-step advertising approval flow: first obtain the licence, then agree the advertising text with the supervisory authority; neither step may be skipped.
3. Compare the advertising text sentence by sentence against the approved instructions for use. Under Article 45(6), build a sentence-level comparison table between the advertising text and the instructions, ensuring no claim exceeds the scope of the instructions.
4. Manage professional exchanges and instructions as non-advertising material. Under Article 45(7)(1) and (2), establish a separate content review process for technical exchanges and product descriptions addressed to professionals, and file them separately from advertising.
5. Handle comparative claims conservatively. Under Article 45(5), even though the provision refers to medicines, device advertising should avoid comparison with other products to reduce compliance risk.

5. Verification checklist

• □ Confirmed that Article 45(1) prohibits advertising of unregistered products and suspended advertising until registration is completed
• □ Built the two-step advertising approval flow of Ministry of Health licence plus agreement of text with the supervisory authority (Article 45(2) and (6))
• □ Built a sentence-level comparison table between the advertising text and the approved instructions for use
• □ Classified professional exchanges and instructions under Article 45(7)(1) and (2) as non-advertising material with separate management
• □ Confirmed that Article 45(8) permits advertising of medical devices in all publications under the statutory procedure
• □ Avoided comparative claims in advertising (conservative treatment of Article 45(5))
• □ Included the liability provisions of Article 45(9) and Article 48 in the violation response plan

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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