The legal framework for the circulation of medicinal products is established by the Law of the Republic of Azerbaijan “On Medicinal Products”. Import, production, sale and use of medicinal products is allowed only after state registration.
Registration of medicinal products is performed in the name of the Applicant (Marketing Authorization Holder). Any legal entity, resident or non-resident of the Republic of Azerbaijan, may be the Applicant. Cratia can act on behalf of the Applicant in the Republic territory as representative (attorney) in regulatory issues.
Registration of medicinal products is carried out by the Ministry of Health of the Republic of Azerbaijan, and the expert evaluation of registration documents is carried out by the Analytical Expertise Center (AEC) of the Ministry of Health of the Republic of Azerbaijan.
The state registration procedure is regulated by Order No. 108 dated July 13, 2007, “Rules for State Registration and Maintenance of the Register of Medicinal Products,” approved by the Resolution of the Cabinet of Ministers of the Republic of Azerbaijan No. 108 dated July 13, 2007.
A medicinal product Marketing Authorization is issued for a period of 5 years. For renewal procedure, the Applicant must submit a cover letter at least 120 calendar days before the expiration of the Marketing Authorization.
NB! Changes to the registration procedure will come into force from July 1, 2020 approved by the Decree of the Cabinet of Ministers of Azerbaijan № 502 from 25.12.2019 “Procedure for conducting an expert examination of medicines”. The most significant changes:
- Registration dossier is accepted in CTD format only;
- The Application for renewal of registration shall be submitted not later than 210 days prior to the expiration of the registration certificate;
- Accelerated expertise for medicinal products registered in the EU under the centralized procedure is being introduced.
Requirements for the registration dossier:
To start the registration process, a cover letter, Application form, and registration dossier must be submitted. According to the legislation, the registration dossier is submitted in the national format, however, currently the dossier is accepted also in the CTD format. Administrative documentation is submitted in paper form; technical documentation is submitted in electronic format. Part of the administrative documentation must be properly legalized.
The registration dossier is filed with a partial translation into Azerbaijani or Russian. The registration dossier must include instructions for human use in the Azerbaijani language, as well as package labeling in Azerbaijani or Russian.
For laboratory quality control, it is necessary to submit samples of the finished medicinal product and standards in the amount required for a triple analysis along with the registration dossier.
Registration procedure:
The registration procedure consists of several stages and includes an initial and specialized expert evaluation. A specialized expert evaluation includes a laboratory test of a medicinal product, an assessment of regulatory and technical documentation and the results of clinical and pharmacological toxicological tests.
During registration, the AEC has the right to request the missing documents or information; the Applicant must provide the necessary responses to such comments within 90 days. Time needed for the preparation of responses to comments is not included in the total period of expert evaluation.
Inspection of production during registration is not required.
The duration of the registration procedure is not more than 180 calendar days, excluding the time for the preparation of responses to comments.
As a result of registration, a Marketing Authorization is issued for a period of 5 years, and the medicinal product is entered into the State Register of Medicinal Products. Instructions for human use and package layouts are issued together with the Marketing Authorization. Upon expiration of the marketing authorization, it is possible to carry out a renewal procedure.
Changes and renewal
During the period of validity of the Marketing Authorization, the Applicant has the right to apply to the AEC for changes (amendments) not later than 3 months from the date of the manufacturer’s decision for amending. The legislation describes 13 types of variations and the relevant documentation for their introduction. It is also necessary to submit samples of the medicinal product when amending.
For renewal, the Applicant must submit a cover letter at least 120 calendar days before the expiration of the Marketing Authorization. The renewal procedure is almost similar to the initial registration procedure, while the cost of the expert evaluation is lower. It is also required to submit medicinal product samples and standards for Marketing Authorization renewal.
After renewal, the Marketing authorization is issued for the next 5 years.
Cratia provides professional services on the establishment and maintenance of state registration of medicines in Azerbaijan. We have an excellent knowledge of national legislation, necessary experience and resources.
To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua, or visit our office.