Azerbaijan Combination Devices: The Expertise-First Pathway for Products with a Medicinal Substance

1. Key takeaways

Devices incorporating a medicinal substance follow a dual-stage pathway: expertise first, registration second. Article 4.4 provides that where a device composed of natural or synthetic substances or their combinations, manufactured into a pharmaceutical form at a specific dose, submits documents containing information on a medicinal substance during state registration, the quality, effectiveness and safety of the medicinal substance in its composition must be examined by the Analytical Expertise Center, AEC, before state registration; that examination is conducted under Resolution No. 502.

This pre-registration expertise directly changes the starting point for issuance: Article 7.1 provides for Article 4.4 devices that the certificate is issued within 7 working days from the date the expertise opinion is submitted to the Ministry of Health (for ordinary devices, within 7 working days from the date the applicant submits the documents to the Ministry). Article 7.12 states expressly that the expertise period is not counted within the review period for the issuance application.

The combined effect is that the medicinal-substance route carries an open-ended lead segment: the statutory clock covers only the final 7 working days, while everything before that depends on the pace of the AEC examination.

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 4.4 (devices incorporating a medicinal substance require AEC expertise first), Article 7.1 (issuance within 7 working days from submission of the expertise opinion for Article 4.4 devices), Article 7.12 (expertise period excluded from the issuance review period), Article 7.2 (modification, within 7 working days from submission of the expertise opinion for Article 4.4 devices), Article 9.1 (notarised Azerbaijani translation of instructions for use for devices with a medicinal substance, checked by the institution and confirmed by the Ministry of Health), Article 9.2 (confirmed instructions published as PDF on the AEC website), Article 10.4.7 (active ingredients and dosage information of the medicinal substance recorded in the register).
• Resolution No. 502 of the Cabinet of Ministers of the Republic of Azerbaijan dated 25 December 2019 on the Rules for Performing Expertise of Medicines (including simplified expertise) (Xalq qəzeti No. 290 of 28 December 2019; Legislative Bulletin 2019 No. 12, item 2083; effective 1 July 2020) — the expertise implementation rules.
• Law of the Republic of Azerbaijan on Medicines (Law No. 208-IIIQ, adopted 22 December 2006, effective 28 February 2007, Legislative Bulletin 2007 No. 2, item 70), as amended by Law No. 979-VIQD of 14 July 2023 (adding Articles 1-1 and 9-1, Legislative Bulletin 2023 No. 8, item 1127): Article 1.0.8 (definition of state registration).

3. Expert insights

Insight one: Article 4.4 turns medicinal-substance content into a process switch, not merely an added document. For ordinary devices the issuance clock starts on the date the applicant submits the documents to the Ministry of Health; for Article 4.4 devices it starts on the date the expertise opinion is submitted to the Ministry. One phrase of difference means: the real cycle for a medicinal-substance device equals the expertise period plus 7 working days, and Article 7.12 expressly excludes the expertise period from the review period — days without a statutory cap are carved out of the timeline.

Insight two: the instructions-for-use confirmation under Article 9.1 is mandatory only for this category. Article 9.1 covers instructions for use of medicinal products and devices incorporating medicinal substances: the applicant submits the notarised Azerbaijani translation, AEC checks it, and the Ministry of Health confirms it. Pure devices are outside its scope — a typical case of a provision that looks general but is actually category-specific.

Insight three: Article 10.4.7 pushes medicinal-substance information into the public register. Where a device incorporates a medicinal substance, the register must record the active ingredients and dosage information of that substance. The formulation therefore becomes publicly visible; where trade secrets are involved, raise a confidentiality claim under Article 13.1 separately and identify the confidential portions in the cover letter.

Insight four: modifications run through the same dual-stage channel. Under Article 7.2, when certificate information changes, Article 4.4 devices again receive the new certificate within 7 working days from submission of the expertise opinion, and the new certificate’s validity is limited by the previous one. Any change to the medicinal substance or its dosage requires fresh expertise — the largest hidden lifecycle cost of this category.

4. Practical recommendations

1. At project start, determine whether the product falls under Article 4.4: composed of natural or synthetic substances or combinations, manufactured into a pharmaceutical form at a specific dose, and containing a medicinal substance.
2. Schedule as expertise period plus 7 working days, not a flat 7; the expertise period has no fixed statutory cap, so back-plan from actual AEC notices.
3. Run instructions for use through the Article 9.1 three-step flow (submission, AEC check, Ministry confirmation) and prepare the notarised Azerbaijani translation early.
4. For commercially sensitive medicinal-substance information, file a separate volume under Article 13.1 and specify the confidential scope in the cover letter.
5. Route any change to the substance or dosage through fresh expertise plus issuance under Article 7.2, and budget for it in the lifecycle plan.
6. Establish a written tracking mechanism with AEC and confirm the expertise status weekly.

5. Verification checklist

• □ Whether the product falls under Article 4.4 (device incorporating a medicinal substance) has been determined.
• □ The schedule is built as expertise period plus 7 working days.
• □ The notarised Azerbaijani translation of the instructions for use is prepared under Article 9.1.
• □ A confidentiality claim for sensitive medicinal-substance information has been raised under Article 13.1.
• □ Re-expertise costs for substance changes are included in the lifecycle budget.
• □ A written tracking mechanism with AEC for the expertise progress is in place.

• Article 15 — Additional documents for sterile devices: validation, bioburden, pyrogenicity and sterility: https://www.grzanglobal.com/azerbaijan-medical-device-registration/sterile-device-additional-documents/
• Article 17 — IVD-specific requirements: Section 7 of the classification decision and the exemption rule: https://www.grzanglobal.com/azerbaijan-medical-device-registration/ivd-specific-requirements/
• 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/

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers and authorised representatives in navigating the Article 4.4 expertise-first pathway for devices incorporating medicinal substances in Azerbaijan, from AEC examination planning and instructions-for-use confirmation to confidentiality claims under Article 13.1. For tailored assistance with your Azerbaijan combination device registration, contact us at info@grzanglobal.com.