Medicinal Products Registration in Azerbaijan

The state registration of medicinal products in Azerbaijan is regulated by the Analytical Expertise Center under the Ministry of Health of the Republic of Azerbaijan. In accordance with the Law of Azerbaijan “On Medicinal Products”, medicinal products may be placed on the market in Azerbaijan only after state registration and inclusion in the State Register.

Key registration facts

90 / 14

Calendar / Working days

Official timeframe for specialized examination (national) and simplified recognition procedures respectively

~2

Months

Average practical duration for the simplified recognition procedure, depending on dossier completeness

5

Years

Validity term of the Registration Certificate, after which a renewal procedure must be initiated

90

Days

Renewal application must be submitted at least 90 calendar days before the current registration expires

Procedures for registration of medicinal products in Azerbaijan

Azerbaijani legislation provides two procedures for including a medicinal product in the State Register:

• Recognition of the state registration within the framework of conducting the simplified procedure (used only for medicinal products that have been manufactured and registered in one of the countries listed below or have been manufactured in other countries, but have been registered in at least two countries, where regulatory authorities apply high quality standards)*
  * Countries of EU Member States, EFTA Members (Iceland, Liechtenstein, Norway and Switzerland), the countries that have the CU Agreement with EU (Andorra, San Marino and Turkey), UK, USA, Japan, Israel and foreign (international) organizations, such as World Health Organization and European Medicines Agency.
• National state registration of medicinal products within the framework of conducting the separate procedure.

Requirements for recognition of the state registration in Azerbaijan

To initiate the procedure for recognition of the foreign (international) registration of the medicinal product, the applicant must submit the following documents to the Analytical Expertise Center under the Ministry of Health of Azerbaijan:

1. Application and Registration forms with the attached documents in paper and electronic form:
   • Legalized Power of Attorney from the applicant to the representative;
   • Legalized copy of the extract from the state register of legal entities;
   • Legalized copy of the certificate of registration as a taxpayer for the applicant;
   • Legalized copy of instruction for medical use approved in the country of applicant along with its certified translation to Azerbaijani;
   • Proposed mock-ups for the Azerbaijani market in Azerbaijani, English or Russian;
   • Information on the form and dosage of the medicinal product and a sample of labelling;
   • Legalized copy of the permission (license) issued by the authority responsible for the registration of medicinal products in a foreign country or internationally, and valid for at least six (6) months at the time of application (e.g., Free Sale Certificate or Registration Certificate issued by the competent authority of the country, where the medicinal product is registered);
   • Unique authorization number of the medicinal product;
   • Legalized copy of a Certificate of a Pharmaceutical Product (CPP) or an equivalent document;
   • Legalized copies of Manufacturing Licenses and GMP Certificates for all manufacturing sites involved in the manufacturing process issued by the competent authorities of countries-manufacturers, (or certified by the applicant if the document is only issued in electronic format);
   • Guarantee Letters from the medicinal product and API manufacturers, as well as CEP and TSE/BSE Certificates, if applicable;
   • Specification (-s) and methods of control of finished medicinal product.
2. Two samples of a medicinal product (in a standard commercial packaging) with the appropriate Certificates of Analysis.

Requirements for national registration of a medicinal product in Azerbaijan

For national state registration of medicinal products, the applicant must submit a full registration dossier to the Analytical Expertise Center, including the following documents:

1. Application and Registration forms with the attached documents in paper and electronic form:
   • Legalized Power of Attorney from the applicant to the representative;
   • Legalized copy of the extract from the state register of legal entities;
   • Legalized copy of the Certificate of Registration as a taxpayer for the applicant;
   • Legalized copy of Registration Certificate or Certificate of a Pharmaceutical Product (CPP) or Free Sale Certificate (FSC) issued by the competent authority of country, where the medicinal product is registered (or certified by the applicant if the document is issued only in electronic format or a legalized copy);
   • Legalized copies of Manufacturing Licenses and GMP Certificates for all manufacturing sites involved in manufacturing process issued by the competent authority of countries-manufacturers (or certified by the applicant if the document is issued only in electronic format);
   • Guarantee Letters from the medicinal product and API manufacturers, as well as CEP and TSE/BSE Certificates, if applicable;
2. Registration dossier in the electronic format of the common technical document (eCTD);
3. Three samples of a medicinal product (in a standard commercial packaging) and standard samples with the appropriate Certificates of Analysis.

In addition, Azerbaijani legislation allows the competent authority to require the appointment of a local contact person responsible for pharmacovigilance (CPPV) based in Azerbaijan. This information must be included in the registration dossier. Our company provides services for acting as a local pharmacovigilance representative (CPPV) in Azerbaijan.

Duration of registration process

According to Azerbaijani legislation, the recognition (simplified) procedure is officially completed within 14 working days. In practice, the procedure typically takes approximately 2 months, depending on the completeness of the submitted documentation and the number of requests issued by the competent authority.

The national registration procedure consists of a preliminary examination (up to 15 working days) followed by a specialized examination of the submitted documentation and samples of the medicinal product (up to 90 calendar days). These timeframes do not include the time required to prepare responses to official requests, if any.

Validity term and renewal

The Registration Certificate for a medicinal product in Azerbaijan is valid for five years and must be renewed every five years thereafter. The renewal procedure must be initiated no later than 90 calendar days before the expiration of the current registration.

For more detailed information, including on the costs associated with registration of medicinal products in Azerbaijan, list of documents required for submission, etc. please contact our specialists.