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Drug Registration Process in Azerbaijan

Drug Registration Process in Azerbaijan

MoH: Ministry of Health of the Republic of Azerbaijan.

MoH website:  https://sehiyye.gov.az/en/

Regulatory Authority: Azerbaijan Energy Regulatory Agency

Link for Regulatory Authority: https://regulator.gov.az/en/

License validity:  5 Years

Renewal period: 2 months before the expiration of the registration period.

Fees: 126 US$11 (New chemical entity and generic)

Dossier Format: The dossier should be submitted in eCTD (Common Technical Document) format. 

Legislative acts:

  1. Law of the Republic of Azerbaijan dated December 22, 2006 “On Medicinal Products”;
  2. Order No. 108 dated July 13, 2007, “Rules for State Registration and Maintenance of the Register of Medicinal Products”;
  3. Decree of the Cabinet of Ministers of the Republic of Azerbaijan dated December 25, 2019, No. 502 “Procedure for the examination of medicines”;
  4. Decree of the Cabinet of Ministers of the Republic of Azerbaijan dated July 10, 2018, No. 287 “Rules for the examination of biologically active food additives”.

Product Registration in Azerbaijan:

  • The Law of Georgia “On Medicinal Products and Pharmaceutical Activities” and Georgia’s Order No. 337/N, “Requirements for Labelling of Pharmaceutical Products Admitted to the Georgian Market under the National State Registration Regime,” are the two main pieces of legislation.
  • According to the law about medicines and pharmaceutical activities in Georgia, medicines can be sold in the country after going through a process called “admitting a pharmaceutical product to the market.” This process involves evaluating the product and adding it to the official list. There are two ways a product can be added:
  1. The fast-track route, where the product is quickly approved by recognizing its registration in other countries with high regulatory standards, like the EMA, USA, Australia, etc.
  2. The national route, where products not covered by the fast-track route undergo a local assessment for registration.
  • In simple terms, medicines can be sold in Georgia after passing either a quick recognition process or a local assessment, depending on their origin and regulatory status.
  • The Ministry of Labor, Health, and Social Affairs in Georgia is responsible for registering medicines. The Agency for State Regulation of Medical Activities in Georgia is the authority that examines and evaluates the registration documents to make sure everything is in order.

Initial registration by recognition procedure  

For the procedure, a package of documents is submitted with reference standards in an amount sufficient for 2 tests, and samples of 2 packages of the finished product or also in an amount sufficient for 2 tests.

In the recognition process, a packaging design is submitted and approved. It should match the registered and authorized packaging layout of the reference country’s pharmaceutical market, whose registration is acknowledged. If documents and design are in English, only the instructions for human use need to be translated into Georgian when submitting them.

If the documents are in a different language, all administrative papers, including packaging design, are translated into Georgian and then notarized. The technical portion is given only in electronic form in English.

Time: 15 Calendar days.

Based on the results of the expert evaluation of registration documents, a Marketing Authorization is issued.

The Ministry of Labor, Health, and Social Affairs of Georgia uploads the authorized packaging and user instructions on its website.

Initial registration by the national procedure

Documents for expert assessment are presented to the Agency in a local format, including samples of the final medicine and reference standards required for a double test. The dossier should be in the national format, and the CTD format is not acceptable. Registration documents are presented in a local style and consist of two parts: administrative and scientific-technical. The administrative portion should be in Georgian and submitted in hard copy, while the scientific-technical part should be in Georgian, Russian, or English, provided in triplicate, and can be submitted in either hard copy or electronic form.

Instructions for use should be in Georgian or with a translation into Georgian.

Packaging labels may be in Georgian, and/or Latin, and/or Slavic-Cyrillic alphabets. Multilingual packaging registration is permitted. During the expert assessment phase, the relevant authority may provide feedback, and the Applicant is granted a period of up to 2 months to address and resolve these comments. If the comments cannot be addressed within the specified timeframe, the medicinal product may be removed from the registration process.

Time period: 3 months (excluding the time required to the manufacturer in providing responses to comments.)

In Georgia, a pharmaceutical product may be circulated up until the shelf life expires after the registration expires.

Product Registration documents and Requirements in the Republic of Azerbaijan

  • Following documents to be submitted in hard (paper) format (1 copy each)
  1. Application for the registration of the medicinal product (see appendix № 1).
  2. Cover letter on official letterhead or stamped, containing details such as trade name, INN, dosage form, and brief information about the manufacturer. Address the letter to the head of the Analytical Expertise Center.
  3. Power of attorney (if the manufacturer delegates registration functions to another party).
  4. Information confirming the official status of the medicinal product:

4.1 Document confirming the registration of the medicinal product in the manufacturing   country (original or notarized copy) – Certificate of Pharmaceutical Product, Free Sale Certificate, or Registration Certificate.

4.2 Document confirming the registration of the medicinal product in other countries, as approved by the manufacturer (if required, provide a notarially certified copy of registration certificates).

4.3 For medical products manufactured under license, provide a notarially certified copy of the license holder’s permission.

4.4 Document confirming the manufacturing of the medicinal product and evidence of manufacturing under conditions consistent with reliable manufacturing practices (original or notarially certified copy) – Manufacturing license and GMP certificate.

4.5. Certificate of Analysis of the finished drug product, active ingredients, and excipients (COA) – provide a copy certified by the manufacturer.