Azerbaijan State Registration Cancellation: Five Grounds and 2-Working-Day Service

1. Key takeaways

Part 12 of Rules No. 345 provides that, except in the cases set by Article 26.1 of the Law on Licenses and Permits, the State registration of medicines, pharmaceutical substances and devices is also revoked in the following situations (Articles 12.1.1 to 12.1.5):

12.1.1 the certificate holder breaches vigilance obligations in the field set by the Pharmacovigilance Rules;

12.1.2 a benefit/risk assessment conducted as required by the Pharmacovigilance Rules concludes with a negative result;

12.1.3 during an inspection of a production site under the Law on the Regulation of Inspections in the Entrepreneurial Field and the Protection of Entrepreneurs, the agency issues a final opinion that medicines and pharmaceutical substances do not comply with good manufacturing practice requirements;

12.1.4 inconsistencies are found in the quality indicators of three batches of a registered medicine, pharmaceutical substance or device;

12.1.5 the actual composition of a registered product differs from the composition stated in the registration documents.

Article 12.2 provides that revocation is decided by the Ministry of Health and is delivered or sent by registered mail to the certificate holder within 2 working days of the decision; Article 12.3 provides that the revocation is published in the periodical press; Article 10.6 requires the Register to record the fact and the date of revocation.

2. Legal basis

• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of 18 July 2024 approving the Rules for the State Registration of Medicines, Pharmaceutical Substances and Medical Devices, Their Entry in the State Register and the Maintenance of the State Register (in force from 19 July 2024; Xalq qəzeti No. 151 of 20 July 2024; Legislative Collection 2024, No. 7, Article 906; repealing Resolution No. 108 of 13 July 2007 with effect from 20 July 2024): Articles 12.1.1 to 12.1.5 (the 5 revocation grounds), Article 12.2 (decision by the Ministry of Health, delivery or registered dispatch within 2 working days), Article 12.3 (publication in the periodical press), Article 10.6 (Register entry of the revocation and its date), Article 11.2 (recall decision under Resolution No. 460 in case of suspension).
• Resolution No. 503 of the Cabinet of Ministers of the Republic of Azerbaijan of 25 December 2019 on Pharmacovigilance Rules, and Resolution No. 460 of the Cabinet of Ministers of the Republic of Azerbaijan of 27 November 2019 on the Rules for the Withdrawal of Medicines.
• Law of the Republic of Azerbaijan on Licenses and Permits (No. 176-VQ of 15 March 2016), Articles 18.2.1–18.2.3, 19.9, 25 and 26.1: Article 26.1 (other statutory grounds for revocation), Article 25 (other statutory grounds for suspension).

3. Expert insights

Insight one: Article 12.1.4 turns inconsistencies in the quality indicators of three batches into a revocation ground — the provision devices are most likely to touch. The wording is explicit: inconsistencies found in the quality indicators of three batches of registered medicines, pharmaceutical substances and devices. Three batches is a low threshold: three consecutive batches with quality deviations can trigger revocation. Batch-by-batch quality files and a deviation ledger are the only defence against this provision.

Insight two: the composition-difference ground of Article 12.1.5 applies to devices as well. The provision covers medicines, pharmaceutical substances and devices, and the test is a difference between the actual composition and the composition stated in the registration documents. For a device this includes, but is not limited to, material substitution, a change of supplier for key components, and substantive software version changes. Any change affecting composition must go through change of State registration under Article 1.5, otherwise it falls directly under Article 12.1.5.

Insight three: Articles 12.1.1 and 12.1.2 elevate vigilance obligations into revocation grounds. A breach of vigilance obligations by the certificate holder, or a negative benefit/risk assessment, is sufficient for revocation. Both provisions rest on Resolution No. 503 on Pharmacovigilance Rules — devices currently have no standalone vigilance rules, yet bear revocation consequences benchmarked against drug rules (see Article 44 of this series).

Insight four: the 2-working-day service under Article 12.2 is a different intensity from the immediate notification for suspension. Article 11.3 requires immediate written information to the certificate holder on suspension; Article 12.2 allows 2 working days for the revocation decision. Both use registered mail as one delivery method, and the recipient capability of the certificate holder directly determines the window for remedies.

Insight five: revocation is final, unlike the recoverable suspension. Article 11.4 expressly provides that suspension lasts until the situation is eliminated, and is therefore recoverable. Revocation, by contrast, is decided by the Ministry of Health under Article 12.2, published in the periodical press under Article 12.3 and recorded in the Register under Article 10.6, and the Rules set out no restoration procedure after revocation. As a practical estimate, the remedy path should be planned as a fresh application for State registration (pending verification: the specific remedy route should be confirmed with local counsel on a case-by-case basis).

4. Practical recommendations

1. Maintain batch-by-batch quality files and a deviation ledger, and treat three-batch inconsistency as an internal red line (Article 12.1.4).
2. Run any substantive change of materials, key components or software versions through change of State registration under Article 1.5 first, leaving no opening for a composition difference under Article 12.1.5.
3. Build an evidence chain of vigilance performance (adverse event collection, assessment and reporting records) to counter Articles 12.1.1 and 12.1.2.
4. Ensure the certificate holder can actually receive registered mail, and notify the Ministry of Health and the AEC of any change of address or contact person at the same time.
5. Once a revocation ground arises, plan the remedy path as a fresh application for State registration and prepare channel and stock arrangements in parallel.
6. Monitor revocation entries in the Register and the periodical press, and brief channel partners in writing within 48 hours of any such entry.

5. Verification checklist

• □ Batch-by-batch quality files and a deviation ledger have been established.
• □ Substantive changes of materials, components and software are routed through change of State registration.
• □ An evidence chain of vigilance performance has been built.
• □ The recipient capability of the certificate holder has been confirmed, and address changes are covered by a simultaneous notification mechanism.
• □ The post-revocation remedy path (fresh application) has been planned.
• □ A 48-hour channel briefing mechanism for revocation entries is in place.

• Article 42 — Suspension of State registration: 4 grounds and a full stop on import, sale and use: https://www.grzanglobal.com/azerbaijan-medical-device-registration/suspension-of-state-registration/
• Article 44 — Device vigilance under the current rules: the spillover of the Pharmacovigilance Rules: https://www.grzanglobal.com/azerbaijan-medical-device-registration/vigilance-current-legal-basis/
• Article 45 — Post-market file consistency maintenance and the annual self-check: https://www.grzanglobal.com/azerbaijan-medical-device-registration/post-market-file-consistency-maintenance/

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and post-market compliance documentation for the Azerbaijan market, from batch quality records and deviation ledgers to vigilance evidence chains and fresh-application planning after revocation. For tailored assistance with your Azerbaijan medical device documentation, contact us at info@grzanglobal.com.