Azerbaijan Resolution No. 345 Rules: 13-Part Structure Guide

1. Key takeaways

The Rules on State Registration of Medicinal Products, Drug Substances and Medical Devices, Entry into the State Register and Maintenance of the State Register, annexed to Resolution No. 345, comprise 13 parts: general provisions, basic concepts, applications for medicinal products and drug substances, applications for devices, grounds for refusal, certificate issuance for medicinal products and drug substances, certificate issuance for devices, validity of certificates, confirmation of instructions for use, maintenance of the state register, grounds for suspension of registration, grounds for revocation of registration, and confidentiality of information, plus 6 annexes. The main battlefield for devices is Parts 4, 7, 9, 10, 11 and 12, while Parts 3 and 6 deal only with medicinal products and drug substances.

The most economical way for device professionals to read the Rules is to read it backwards: first look at Article 8.1 (validity of 5 years) and Article 7.1 (certificate within 7 working days) to fix the timeline, then look at Article 4.2 (11 dossier items) and Article 4.3 (exemptions) to size the document workload, and finally look at Part 5 (refusal) and Parts 11 and 12 (suspension, revocation) to map the risk boundaries.

2. Legal basis

• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of July 18, 2024, approving the Rules on State Registration of Medicinal Products, Drug Substances and Medical Devices, Entry into the State Register and Maintenance of the State Register (effective July 19, 2024; Xalq qəzeti No. 151 of July 20, 2024; Legislative Collection 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 with effect from July 20, 2024): Part 1 (1.1 to 1.7), Part 2 (2.1.1 to 2.1.4), Part 3 (applications for medicinal products and drug substances), Part 4 (applications for devices, 4.1 to 4.5), Part 5 (grounds for refusal, 5.1 to 5.2), Part 6 (certificate issuance for medicinal products and drug substances), Part 7 (certificate issuance for devices, 7.1 to 7.12), Part 8 (validity, 8.1), Part 9 (instructions for use, 9.1 to 9.2), Part 10 (register, 10.1 to 10.7), Part 11 (suspension, 11.1 to 11.4), Part 12 (revocation, 12.1 to 12.3), Part 13 (confidentiality, 13.1), annexes 1 to 6.
• Resolution No. 140 of the Cabinet of Ministers of the Republic of Azerbaijan of April 25, 2025 (amending the Rules annexed to Resolution No. 345, replacing registration certificate (qeydiyyat vəsiqəsi) with certificate (vəsiqə) throughout; Xalq qəzeti No. 86 of April 30, 2025; Legislative Collection 2025, No. 4, book II, item 426) (terminological amendment that does not change the structure).
• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of July 18, 2024 (same publication details as above): Article 1.1 (the Rules are adopted under the first sentence of Article 6.8 of the Law on Medicinal Products, taking into account Articles 1.0.8, the second sentence of 6.1, 6.5, 6.13, 6-2.15, 6-2.17 and 6-2.19).

3. Expert insights

Insight 1: Article 1.2 is the master switch for the scope of application. Article 1.2.1 lists medicinal products, Article 1.2.2 lists drug substances, and Article 1.2.3 lists medical devices of higher, high and (or) medium risk degree. That single sentence determines to whom all subsequent provisions apply, and it means that low risk devices are simply outside the reach of these Rules.

Insight 2: Article 1.5 is a pass-through clause that is extremely easy to miss. It provides that any change to the information and documents listed in Parts 3 and 4 for a registered product must itself undergo state registration. A change is therefore not a notification but a registration, and it goes through the same certificate issuance process and attracts the same state fee.

Insight 3: Article 1.7 offers a fast track that is exclusive to medicinal products. Medicinal products already registered and authorized for marketing in states or by international organizations listed in Resolution No. 480 of the Cabinet of Ministers of December 26, 2023 may follow the recognition of foreign (international) registration route under Article 6-2 of the Law on Medicinal Products. Devices do not benefit from this route, because Article 1-1 places Article 6-2 on the list of provisions that do not apply to devices. Being on the market abroad does not exempt a device from registration in Azerbaijan.

Insight 4: Part 13 is a comfort clause for applicants, but its boundary is narrow. Article 13.1 requires the Ministry of Health and the body to keep confidential the information submitted for registration, re-registration and change registration, not to disclose it to third parties and not to use it for commercial purposes, in accordance with the Law on Information, Informatization and Information Protection, the Law on Access to Information and the Law on Trade Secrets. It protects the submitted information; it does not protect the register fields that are lawfully published.

Insight 5: the numbering and purpose of the annexes must be memorized. Annex 1 is the application form (common to all three product categories). Annexes 2A and 2B, 3A and 3B, and 4A and 4B are certificate formats for medicinal products and drug substances. Annex 5 is the device certificate format and Annex 6 is the device change registration certificate format. Looking at the annex number alone tells you whether a provision is about medicines or devices.

4. Practical recommendations

1. Use the reverse reading method for the first pass: Article 8.1 (validity), then Article 7.1 (issuance), then Articles 4.2 and 4.3 (dossier and exemptions), then Parts 5, 11 and 12 (risks).
2. Treat Article 1.2.3 as the first gate of project initiation: confirm that the risk degree is not low before preparing any budget.
3. Handle every change as a new state registration project under Article 1.5, and never process it as a mere filing.
4. Do not cite Article 1.7 to seek a fast track for devices; there is no foreign registration recognition route for devices.
5. When citing annexes, write the full number (Annex 5 device certificate, Annex 6 device change certificate) to avoid mixing them with the medicinal product annexes.
6. Bind confidential technical material into a separate volume and identify it in the submission letter, citing Article 13.1.

5. Verification checklist

• □ Confirmed that the Rules follow a structure of 13 parts plus 6 annexes, and marked the 6 parts applicable to devices.
• □ Confirmed under Article 1.2.3 that the risk degree of the product falls within the registrable range.
• □ Incorporated the rule that a change equals registration under Article 1.5 into the internal change management procedure.
• □ Excluded the applicability of the foreign registration recognition route of Article 1.7 to devices.
• □ Confirmed the field lists of Annex 5 (device certificate) and Annex 6 (device change certificate).
• □ Bound sensitive technical material into a separate volume and marked it under Article 13.1.

Related reading

• Article 01. Who Regulates Medical Devices in Azerbaijan: the Ministry of Health Issues Certificates and AEC Performs Expertise: https://www.grzanglobal.com/azerbaijan-medical-device-registration/who-regulates-medical-devices-in-azerbaijan/
• Article 02. From Devices Equated with Medicines to Mandatory Registration: the 2023 Amendment and the 2024 Rules: https://www.grzanglobal.com/azerbaijan-medical-device-registration/device-equated-with-medicine-mandatory-registration/
• Article 13. The 11 Dossier Items Explained One by One: 4.2.1 to 4.2.11: https://www.grzanglobal.com/azerbaijan-medical-device-registration/dossier-11-items-breakdown/

This article was translated and published by GRZAN, the international regulatory affairs service of GRZAN Global. For professional support with medical device registration in Azerbaijan, regulatory strategy, dossier preparation and local representation, contact us at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.