Azerbaijan

Population of Azerbaijan is about 10 million people. Pharmaceutical market is one of the fastest growing areas of the economy, but it almost entirely depends on import.

Importation and marketing of medicines are allowed only after getting relevant marketing authorization  (registration). For importation of medical devices and medical equipment  it is required to obtain an official permission and a hygiene certificate. Сosmetic products are also supplied on the basis of a hygiene conclusion. Importation and marketing of food products and supplements (food supplements, baby food, sport food, medical nutrition) are allowed only after their certification and obtaining of conclusion on examination.

Medicinal products:

The legal framework for marketing of medicinal products is established by the Law of the Republic of Azerbaijan “On Medicinal Products”. Importation, production, sales and use of medicines are permitted only after state registration (gaining marketing authorization).

Registration of medicinal products is performed on behalf of an  Applicant (Marketing Authorization Holder). Any legal entity, both resident and non-resident of the Republic of Azerbaijan may act as an Applicant. Company “Cratia” may represent interests of an Applicant as an authorized representative on the territory of the Republic of Azerbaijan.

Registration of medicinal products is performed carried  by Ministry of Health of the country. Examination of registration materials is conducted by Analytical Expertise Center (the Center) of the Ministry of Health of the Republic of Azerbaijan.

Registration dossier:

For starting registration process it is required to submit cover letter, Application form and registration dossier. According to the legislation, registration dossier can be submitted in national format, however, the dossier in CTD format may also be accepted upon preliminary agreement with the regulatory authority. Administrative part of the dossier is submitted in paper form in two copies, technical documentation is submitted via a data storage device.
Part of administrative documentation should be properly legalized.

partial translation into Azerbaijani or Russian languages. Instruction for medical use (Package leaflet)  in Azerbaijani language, as well as package labelling in Azerbaijani or Russian languages are parts of registration dossier.

In order to carry out laboratory quality control it is necessary to submit samples of finished product along with reference standards in the quantity necessary for conducting of three full analysis in  parallel.

Registration procedure:

registration procedure consists of several stages and includes primary and specialized examination. Specialized examination includes laboratory analysis, assessment of normative and technical documentation and assessment of results of pharmaco-toxical and clinical studies.

During examination process the Center may request outstanding documents or information, an Applicant is required to provide requested data within set timelines. Time needed for preparation of replies to the Center requests is not included into  examination time frame.

Inspection of manufacturing site during registration of medicinal product is not required.

Duration of registration process is not more than 180 calendar days starting from the date of examination fee payment by an Applicant.

Registration certificate (Marketing Authorization certificate)  valid for f 5 years is issued as a result of registration, and data about registered medicinal product are included in State Registry of medicinal products. Together with Registration certificate an Applicant gets approved Instruction for medical use (Package Leaflet), package artworks and normative document which includes analytical methods of control, specification, certificates of analysis for finished product and description of medicinal product in Azerbaijani language.

Upon expiration of registration certificate it is possible to carry out repeated registration (renewal)r.

Variations and renewals:

During validity of registration certificate, an Applicant has right to apply to the Center for providing variations  (amendments) no later than in three months after decision to implement such changes is taken by manufacturing site. The legislation describes 13 types of variations and dossier requirements  for their submission. Along with providing variations It is required to submit samples of medicinal product.

For renewal providing an Applicant should submit a letter-request no later than 120 calendar days before expiration of registration certificate validity. Renewal procedure process is almost the same as a for new registration, and the fee for examination is lower. Submission of the medicinal product samples and reference standards are also required for conducting renewal examination..

Pharmacovigilance:

Competent authority responsible for conducting surveillance of adverse events is Analytical Expertise Center (the Center) of the Ministry of Health of the Republic of Azerbaijan.

national legislation establishes the following cases for submission of information :

• about all adverse reactions for new medicinal products (new medicinal products are considered to be “new” within 5 years after their registration);
• about any unexpected adverse reactions;
• about all serious adverse reactions;
• about adverse effects of drug interactions;
• about unexpected therapeutic effects (previously unknown);
• about the results of observation with clear evidence that medicinal product causes adverse reactions (for example, occurrence of adverse reactions to repeated administration of medicinal product);
• about laboratory abnormalities, the consequences of an overdose (accidental or intentional).

National legislation provides different deadlines for safety information submission depending on the nature and characteristics of undesirable events. For example, information on all serious and severe adverse reactions as well as unexpected adverse reactions should be directed to the Center as soon as possible, but no later than in3 three days.

Medical devices and equipment:

Azerbaijan’s legislative requirements for importation and marketing of medical devices and medical equipment are quite simple. In order to import the products it is necessary to obtain a confirmation letter regarding medical device type (classification) and then to obtain a hygiene certificate from the Republican Center of Hygiene and Epidemiology of the Republic of Azerbaijan.

Documents for registration of medical devices in Azerbaijan should be submitted in Azerbaijani, Russian or English languages.

Instruction for use (user’s manual) should be provided in Azerbaijani.

Package labelling is permitted in either Russian or English or Azerbaijani at option of an Applicant. Package labelling in Turkish is allowed as well.

The procedure for obtaining all documents required to importation and marketing medical devices on the market takes about 1-1.5 months.

Food products and supplements

Certification of food products and supplements is conducted by Analytical Expertise Center (the Center) of the Ministry of Health of the Republic of Azerbaijan and consists of two stages: examination of dossier and laboratory analysis of samples. As the result a company obtains conclusion on examination valid for one year.

The instruction for use should be presented in Azerbaijani, and package labeling maybe presented in Russian, English, Azerbaijani or Turkish.

The procedure for obtaining all documents required to import and market the mentioned products in the country takes about two months.

Сosmetic products:

The procedure for obtaining import permission for cosmetic products is similar to the medical devices procedure, and consists of two main stages:

• receipt of a letter-conclusion from the Center;
• receipt of a hygiene certificate from the Republican Center of Hygiene and Epidemiology of the Republic of Azerbaijan.

The instruction for use should be presented in Azerbaijani, and package labeling maybe presented in Russian, English, Azerbaijani or Turkish.

The procedure for obtaining all documents required to import and market the mentioned products in the country takes about 1-1.5 months.

“Cratia” can provide services on state registration of medicinal products, establishment and maintenance of pharmacovigilance system, certification of medical devices, food products and supplements and cosmetic products in Azerbaijan.