Azerbaijan Medical Device Registration 2026: Application Form (Annex 1) – Completion Points and Criminal-Liability Declaration

1. Key takeaways

Annex 1 of Resolution No. 345 sets out the format of the application form for the state registration of medicinal products, drug substances and medical devices, and the same form is used for all three product categories. Its structure falls into four blocks:

Applicant information — for legal entities, the name and legal address, the taxpayer identification number, and the name, patronymic and position of the head or authorised person, plus the number, issue date and issuing authority of the identity document; for natural persons (sole proprietors), the name, patronymic and address, plus the number, issue date and issuing authority of the identity document; for state bodies, the name, the name, patronymic and position of the head, and the taxpayer identification number.

Application text — the applicant states that documents are submitted for the state registration of the named medicinal product (drug substance or medical device), that the submitted documents and information are true, and that the signatory is aware of the criminal liability for the use of forged documents.

List of accompanying documents — each item is listed one by one.

Signature and contact details — the signature and seal (M.Y.) of the applicant or head of the state body, the date, and the telephone, fax and e-mail address.

Article 3.5 additionally provides that where the documents are submitted by a person (representative) authorised by the applicant, a document proving the corresponding rights, such as a power of attorney or a contract, must be attached to the application. The form is submitted together with the eleven-item dossier listed in Article 4.2, and incomplete or inaccurate entries can trigger the defect procedure under Article 7.3.

2. Legal basis

• Resolution No. 345 of the Cabinet of Ministers of the Republic of Azerbaijan of July 18, 2024 on the Rules for the State Registration of Medicinal Products, Drug Substances and Medical Devices, Their Entry in the State Register and the Maintenance of the State Register (effective July 19, 2024; Xalq qəzeti No. 151 of July 20, 2024; Legislative Compilation 2024, No. 7, item 906; repealing Resolution No. 108 of July 13, 2007 as of July 20, 2024): Annex 1 (format of the application form), Article 4.2 (devices are filed with the application form of Annex 1), Article 3.5 (submissions by an authorised representative must be accompanied by authorisation documents), Article 5.1.2 (untrue information found in the submitted documents is a ground for rejection), Article 2.1.1 (definition of the applicant).
• Law of the Republic of Azerbaijan on Licences and Permits (Lisenziyalar və icazələr haqqında), No. 176-VQ of March 15, 2016, Articles 18.2.1 to 18.2.3, Article 19.9, Article 25 and Article 26.1: Articles 18.2.1 to 18.2.3 (documents on the legal status of the applicant).
• Administrative Procedures Law of the Republic of Azerbaijan, Article 31 (acceptance and registration of applications) and Article 52 (correction of defects): Article 31 (acceptance and registration of applications), Article 52 (correction of defects).

3. Expert insights

Insight 1: The criminal-liability statement in the form is not boilerplate. The application text of Annex 1 places the statement that the submitted documents and information are true side by side with the statement of awareness of criminal liability for forged documents, which maps directly to Article 5.1.2, under which untrue information found in the submitted documents is a ground for rejection. The signatory must be the head of the legal entity or a duly authorised person, and the chain of authorisation must be reflected in the documents required by Article 3.5. A signature by an unauthorised person can therefore compromise the entire submission, not merely the form itself.

Insight 2: The form requires different data items for each of the three types of applicant, and this is the most common source of errors. Legal entities must state the taxpayer identification number and the legal address; sole proprietors must state their name, patronymic and address; state bodies must state the position of the head. Choosing the wrong entity type distorts the structure of the whole form, which in turn can trigger the defect notice under Article 7.3 (five working days) and the correction window under Article 7.4 (ten working days). The three entity options also match the certificate holder field of the Annex 5 certificate, so the entity selected on the form must remain consistent throughout the dossier.

Insight 3: The contact details block is the physical entry point for all subsequent procedural correspondence. The end of Annex 1 requires a telephone, fax and e-mail address. The defect notice under Article 7.3 and the rejection notification under Article 5.2 are sent by registered mail as the statutory channel, but in practice telephone and e-mail are usually faster. Maintaining a mailbox that can actually receive correspondence in Azerbaijani is more valuable than a mailbox that is only monitored domestically, because unanswered defect notices run directly into the fixed correction deadlines.

Insight 4: The list of accompanying documents serves as a self-check list for the dossier. Annex 1 leaves two blank lines for listing the accompanying documents. This block should correspond item by item to the eleven items of Article 4.2, with the relevant clause numbers noted. A mismatch between the list and the actual dossier can fall under Article 5.1.4, which treats inconsistent documents as a ground for rejection.

Insight 5: The application form does not distinguish between first registration and re-registration. The title of Annex 1 is the application form for state registration of medicinal products, drug substances and medical devices, and the body of the form contains no field for first registration or re-registration. The distinction between re-registration and change registration is instead reflected in the procedure and in the numbering of the annexes (Annex 5 for first registration, Annex 6 for changes), so stating the type of application in the list of accompanying documents is a necessary practical step.

4. Practical recommendations

1. List the accompanying documents in the Annex 1 block item by item against the eleven items of Article 4.2, noting the clause numbers from 4.2.1 to 4.2.11.
2. State the type of application (state registration, re-registration or change registration) at the top of the accompanying documents block.
3. Ensure that the identity of the signatory matches the authorised person named in the Article 3.5 authorisation documents; where a representative files the application, a power of attorney must be attached.
4. Enter an e-mail address capable of receiving correspondence in Azerbaijani and a local telephone number that is reachable.
5. Confirm the applicant type (legal entity, sole proprietor, or branch or representative office of a foreign legal entity) before completing the form, and fill in the data items that correspond to that type in Annex 1.
6. Before filing, check the application form against the physical dossier item by item to make sure that the list and the actual documents match.

5. Verification checklist

• □ The applicant information has been completed according to the entity type selected for Annex 1.
• □ The accompanying documents have been listed item by item against 4.2.1 to 4.2.11 with clause numbers noted.
• □ The type of application (registration, re-registration or change) has been stated in the list block.
• □ The identity of the signatory has been checked against the authorisation documents.
• □ The contact details can receive e-mail in Azerbaijani and the telephone is reachable.
• □ The application form has been checked item by item against the physical dossier.

Related reading: Manufacturer Production Right Document and Annexes (https://www.grzanglobal.com/azerbaijan-medical-device-registration/manufacturer-production-right-document/); Brief Description: Scope, Purpose and Accessories (https://www.grzanglobal.com/azerbaijan-medical-device-registration/brief-description-scope-purpose-accessories/); Dossier of Eleven Items: Breakdown of 4.2.1 to 4.2.11 (https://www.grzanglobal.com/azerbaijan-medical-device-registration/dossier-11-items-breakdown/).

GRZAN provides regulatory consulting for medical device manufacturers and exporters, covering Azerbaijan state registration dossiers, application forms and annexes, authorised representative arrangements, labelling compliance and post-market obligations. For tailored support on this topic, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of October 30, 2026.