In Azerbaijan, the rule on the recognition of international registration of medicines has been determined

A new rule on the recognition of foreign (international) registration of medicinal products has been established in Azerbaijan.

According to "Report", this was made possible by President Ilham Aliyev's approval of changes to the Law "On Medicines".

Thus, according to the law, the recognition of the foreign (international) registration of the medicinal product is carried out in accordance with the laws "On licenses and permits", "On administrative proceedings" and this law. The applicant will apply to the authorizing body for recognition of the foreign (international) registration of the medicinal product and entry into the state register.

The following shall be attached to the application:

- a copy of the extract from the state register of legal entities;

- a copy of the certificate on registration of the applicant as a taxpayer;

- instructions for use of the medicinal product and its notarized translation into Azerbaijani;

- information on the form and dosage of the medicinal product and a sample of labeling that can be presented in physical or electronic form;

- a copy of the permission (registration card) issued by the body regulating the registration of medicinal products in a foreign country or at the international level and valid for at least six months at the time of application;

- unique number of the authorization for the use of the medicinal product;

- Original or apostille or legalized copy of the Pharmaceutical Product Certificate or an equivalent document;

- analysis methods that can be obtained from an open information source (pharmacopoeia articles) with reference to the source;
- two samples of the drug (in standard commercial packaging).

If it is possible to obtain the documents or information specified in the law by the authorizing body from the relevant state body (institution) through the Electronic Government Information System, those documents or information are not required from the applicant. In cases where it is not possible to obtain such documents or information through the Electronic Government Information System, their submission is requested from the relevant state body (institution) with the consent of the applicant or is provided by the applicant.

The application is received and registered by the authorizing body in accordance with the Law "On Administrative Proceedings".

Within 11 (eleven) working days from the date of registration of the application, the authorizing body recognizes the foreign (international) registration of the medicinal product and enters it into the state register or makes a decision on refusal based on the results of reviewing the application, the documents (data) attached to it and the simplified examination of the medicinal products. .

If deficiencies are found in the application and in the documents (information) attached to it, which can be eliminated and do not lead to rejection, the authorizing body shall provide information on their elimination to the applicant in writing or electronically no later than two working days from the date of registration of the application, and shall notify the applicant of non-compliance with formal requirements. explains the legal consequences to him. All deficiencies must be reported to the applicant at the same time.

The applicant must eliminate those deficiencies no later than 10 (ten) working days from the time of receiving the information. At this time, the period mentioned in the law is stopped and the suspended period is not included in the period of administrative proceedings. After the applicant's request to eliminate the deficiencies, the period is restored.

If no deficiencies are found in the application and the documents (data) attached to it, the authorizing body shall, within two working days from the date of registration of the application, submit to the applicant, by registered mail or electronically, the agreement on conducting a simplified examination of medicinal products and the invoice for the payment of the cost of that examination. does.

After receiving the contract, the applicant signs it within two working days and pays the cost of the simplified examination of medicinal products on the invoice to the bank account of the authorizing body.

The licensing body performs a simplified examination of medicinal products by examining the documents (data) attached to the application within three working days after the applicant has paid the cost and submitted the document confirming it.

If the result of the simplified examination of medicinal products is positive, the authorizing body informs the applicant about the payment of the state fee within one working day by registered mail or in electronic form.