Azerbaijan Registration Deficiencies: The 5-Day Notice, 10-Day Remedy and Deadline Suspension

1. Key takeaways

Articles 7.3 and 7.4 form the deficiency-handling mechanism for device registration:

Article 7.3 — where deficiencies that can be remedied and do not lead to refusal of issuance are found in the application and attached documents, the Ministry of Health, no later than 5 working days from the date the application is registered, provides (or sends by registered mail) the information on remedying them and explains the legal consequences of non-compliance with the formal requirements; all deficiencies are communicated to the applicant at once.

Article 7.4 — the applicant must remedy the deficiencies no later than 10 working days from the date of receiving that information; during this period the issuance deadline is suspended and the suspension period is not counted within the issuance period; the deadline resumes when the applicant submits the request confirming the deficiencies have been remedied.

Article 7.5 — if the deficiencies are not remedied on time, the Ministry of Health issues an administrative act of refusal to consider the application and provides or sends that information by registered mail within 2 working days.

Article 7.6 — after the deficiencies are remedied, the application may be submitted to the Ministry of Health again.

2. Legal basis

• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan dated 18 July 2024 on the Rules for State Registration of Medicines, Drug Substances and Medical Devices, Their Entry into the State Register and Maintenance of the State Register (effective 19 July 2024; Xalq qəzeti No. 151 of 20 July 2024; Legislative Bulletin 2024 No. 7, item 906; repealing Resolution No. 108 of 13 July 2007 as of 20 July 2024): Article 7.3 (notice within 5 working days, all deficiencies communicated at once, legal consequences explained), Article 7.4 (remedy within 10 working days, deadline suspended and excluded, resumption after remedy), Article 7.5 (administrative act of refusal to consider on expiry, notice within 2 working days), Article 7.6 (re-application possible), Article 7.1 (issuance within 7 working days where no deficiencies).
• Administrative Procedure Code of the Republic of Azerbaijan, Article 31 (acceptance and registration of applications) and Article 52 (remedy of deficiencies) — specifically Article 52 (remedy of deficiencies) and Article 31 (acceptance and registration of applications).
• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan dated 18 July 2024 (same instrument as above): Article 5.1.1 (documents not submitted in full and the deficiency not remedied under Article 52 of the Administrative Procedure Code constitutes a ground for refusal).

3. Expert insights

Insight one: communicating all deficiencies at once is an important procedural safeguard. The final sentence of Article 7.3 states that all deficiencies are communicated to the applicant simultaneously. The Ministry cannot drip-feed deficiencies one by one across successive rounds. If notices arrive in batches in practice, the applicant can invoke this sentence and demand a complete list — which materially reduces the number of round trips.

Insight two: the 5 working days run from the application registration date, not from when the Ministry notices the problem. Article 7.3 starts the clock on the date the application is registered. That is not the same date as the document submission date under Article 7.1. The log should carry the application registration date as a separate column and use it to verify whether the notice was issued on time.

Insight three: the legislative intent of the suspension is not to make the applicant pay for the remedy, but the price is an uncontrolled cycle. The second and third sentences of Article 7.4 provide that the issuance deadline is suspended and the suspension is excluded, resuming after the applicant confirms the remedy. This protects the applicant, but it also means the Ministry has no progression duty during the remedy window. The only way to shorten the cycle is to shorten the remedy itself.

Insight four: the refusal to consider under Article 7.5 and the refusal under Article 5.1 are two different paths. Article 7.5 is a procedural shelving (expiry without remedy, refusal to consider, re-application possible under Article 7.6); Article 5.1 is a substantive refusal (including 5.1.1 incomplete documents not remedied under Article 52 of the Administrative Procedure Code, 5.1.2 untrue information, 5.1.4 document inconsistencies). The former allows a restart; the latter requires a different solution.

Insight five: Article 5.1.1 writes Article 52 of the Administrative Procedure Code into the grounds for refusal. This shows the remedy procedure is linked to the Code: the remedy follows Article 52, and failure to remedy can be refused under Article 5.1.1. Applicants should perform and document the remedy steps in the manner the Code requires.

4. Practical recommendations

1. On receiving a deficiency notice, first check whether the notice date falls within 5 working days of the application registration date; raise any overrun in writing.
2. If deficiencies are notified in batches, invoke the final sentence of Article 7.3 to demand a single complete list.
3. Back-plan the remedy against 10 working days, broken down internally as: translation 2 days, technical confirmation 3 days, internal approval 2 days, submission 1 day, buffer 2 days.
4. Obtain a written receipt for the remedy submission as the evidence that starts the resumed deadline.
5. Distinguish the refusal to consider (Article 7.5, re-application under Article 7.6) from the substantive refusal (Article 5.1, new solution needed).
6. Complete the remedy steps as Article 52 of the Administrative Procedure Code requires and keep records throughout.

5. Verification checklist

• □ The log records the application registration date separately to verify the 5-working-day notice period.
• □ On receipt, the notice was checked for containing all deficiencies at once.
• □ The remedy is back-planned against 10 working days and broken down by day.
• □ A written receipt for the remedy submission (start of the resumed deadline) has been obtained.
• □ The refusal-to-consider and substantive-refusal outcomes are distinguished with contingency plans for each.
• □ The remedy process is documented in line with Article 52 of the Administrative Procedure Code.

• Article 18 — Certificate issued in 7 working days: there are actually two start points: https://www.grzanglobal.com/azerbaijan-medical-device-registration/certificate-issued-in-7-working-days/
• Article 20 — The 4 statutory grounds for refusal and the 2-day notice: https://www.grzanglobal.com/azerbaijan-medical-device-registration/four-grounds-for-refusal-2-day-notice/
• Article 13 — The 11 dossier items one by one: 4.2.1 to 4.2.11: https://www.grzanglobal.com/azerbaijan-medical-device-registration/dossier-11-items-breakdown/

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives in managing deficiency notices and remedy cycles for medical device registration in Azerbaijan, from deadline verification and single-list enforcement to receipt management under Article 52 of the Administrative Procedure Code. For tailored assistance with your Azerbaijan deficiency handling, contact us at info@grzanglobal.com.