Tajikistan Registration Certificate Reissue, Cancellation and Withdrawal from Circulation

1. Key takeaways

The exit mechanism for registration certificates in Tajikistan includes a pathway initiated by the registration certificate holder itself. Article 21(1)(4) of Law No. 1893 provides that where the registration certificate holder submits an application to prohibit use, to cancel the registration certificate, or to restrict the circulation and use of medicines, medical devices and parapharmaceuticals, the state supervisory authority for pharmaceutical activity shall withdraw the products from circulation. GRZAN notes that Article 21(1) lists 12 statutory grounds for withdrawal from circulation in total; item 4 is the only voluntary exit pathway, while the remaining 11 items are triggered ex officio by the competent authorities or by statutory facts. Choosing the right pathway, and triggering it at the right moment, is therefore a management decision with direct regulatory consequences.

2. Legal basis

3. Expert insights

Insight 1: The voluntary exit pathway of Article 21(1)(4) is a portfolio management tool for the certificate holder. The provision allows the holder to submit three kinds of applications: prohibition of use, cancellation of the registration certificate, and restriction of circulation and use. The three applications match different commercial scenarios: prohibition of use fits a product with an identified safety problem that has not yet been decided for full exit; cancellation fits a full market exit; restriction of circulation and use fits a narrowing of the intended scope. GRZAN recommends treating these three as standard tools of product lifecycle management rather than as crisis-only instruments.

Insight 2: Article 21(2) entrusts the withdrawal procedure to the Ministry of Health, which means the operational details sit in lower-level documents. The provision requires the procedures for prohibition of use and withdrawal from circulation to be established and approved by the Ministry of Health. GRZAN therefore requests the currently valid withdrawal procedure documents before initiating any withdrawal action, and files the application in accordance with those procedures, rather than sending a free-form letter directly to the supervisory authority.

Insight 3: Article 44(5) lists decisions to cancel national registration among the information that must be published, which makes even a voluntary cancellation public. The provision requires information on decisions to cancel national registration to be published by the supervisory authority in the relevant publications. The implication is that a voluntary cancellation is not a silent act; it will be published. Companies should prepare external communication at the same time as filing the cancellation, to avoid the market misreading it as a forced withdrawal.

Insight 4: Article 21(1)(3) interacts directly with voluntary cancellation. Item 3 provides that products whose registration and re-registration periods have expired before importation into Tajikistan must be withdrawn from circulation. The implication is that if the holder decides not to pursue re-registration, products imported after the five-year expiry will fall under the mandatory withdrawal of item 3 rather than the voluntary pathway of item 4. GRZAN recommends that when the decision to exit the market is made, the holder should file a voluntary cancellation under item 4 rather than let the certificate lapse – the former is controlled and documented, while the latter risks being treated as unlawful circulation.

Insight 5: The reissue mechanism is not expressly provided in Law No. 1893 and belongs to the level of procedural documents. A full review of the law reveals no clause on reissue of a lost registration certificate. GRZAN therefore treats reissue as falling within the procedural documents authorised by Article 17(12), to be established by the Ministry of Health. When a certificate is lost or damaged, companies should follow those procedural documents, and during the waiting period should retain the query results from the State Register of Medicines under Article 17(8) as supporting evidence of the registration status.

4. Practical recommendations

1. Use Article 21(1)(4) as a portfolio management tool. Preset the three voluntary pathways of prohibition of use, cancellation and restriction of circulation in the product lifecycle management process, match each to its commercial decision scenario, and define the approval authority for each.
2. Request the current procedure documents before initiating a withdrawal. Under Article 21(2), obtain the currently valid withdrawal procedure documents from the Ministry of Health and file the application through the prescribed procedure, without sending a free-form letter to the supervisory authority.
3. Prepare external communication in parallel with voluntary cancellation. Under Article 44(5), cancellation information will be published; prepare the external statement at the same time as the filing, making clear that the exit is a voluntary commercial decision rather than a forced withdrawal.
4. File a voluntary cancellation when exiting the market, instead of letting the certificate lapse. Under Article 21(1)(3), continued importation after expiry falls under mandatory withdrawal; cancel voluntarily upon the exit decision and keep the cancellation evidence.
5. Handle certificate reissue through the procedure documents and keep register query records. Under Article 17(12), follow the Ministry of Health procedure documents for reissue; during the waiting period, use the register query results under Article 17(8) as supporting evidence.

5. Verification checklist

• □ Confirmed that Article 21(1)(4) is the only voluntary exit pathway
• □ Distinguished the applicable scenarios of prohibition of use, cancellation of the registration certificate, and restriction of circulation and use
• □ Obtained the currently valid withdrawal procedure documents (Article 21(2))
• □ Prepared the external communication statement for voluntary cancellation (Article 44(5))
• □ Confirmed that market exit is executed through voluntary cancellation, not by letting the certificate lapse (Article 21(1)(3))
• □ Handled certificate reissue through the procedure documents and retained register query records (Article 17(8) and (12))
• □ Preset the three voluntary exit pathways and their approval authorities in the lifecycle management process

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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