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At the beginning of the month, an official decree was released by the Cabinet of Ministers of the Republic of Azerbaijan on approval of the “Regulation on the system of tracking and tracing of medicines”. Here are the outlines of the DVTIS– Azerbaijan Track & Trace system.
Table of Contents
Principles of the system
In the Regulation are stated the four principles on which basis the system operates:
1. Usability – ensuring the convenience of using the system and data exchange without additional operations;
2.Efficiency – quick implementation of the processes of creating, collecting, processing, storing and searching information in the system;
3. Continuity – the absence of dependence of the functioning of the system on the organizational, administrative, technical, and other changes carried out in it;
4. Transparency – ensuring transparency and accountability in the activities of the system, and the ability to track the procedures performed and their results.
System Modules
The structure of the system consists of the following modules:
- Module “Medicines”;
- Module “Medical Products and Medicinal Substances”;
- Module “Pharmacy Organizations”;
- Module “Medical Institutions”;
- Module “Wholesale pharmaceutical enterprises”;
- Module ” Manufacturers and Marketing Authorization Holders”;
- Module ” Prescription”;
- Module “Track and Trace”
Module “Track & Trace”
The module provides information on medicines and medical products produced by local manufacturers, imported into the country by importers, transferred from one enterprise to another, sold to individuals through pharmacies, used inside medical institutions, medicines and medical products whose sales have been stopped or recalled, as well as enterprises in stock engaged in pharmaceutical activities in the territory of the country, as well as on medicinal substances produced by local manufacturers, imported into the country by importers, issuance of electronic permits for the import of medicinal products produced by local manufacturers and imported into the country by importers, as well as issuance of a request to search for information about them, removal of medicinal products from the system in accordance with paragraph.
The module contains 10 submodules.
Scope
The medicines that require reporting are psychotropic and hard drugs.
About imported psychotropic and hard drugs:
- In situation when the medicines are not marked:
When importing drugs from these groups into Azerbaijan, the Department Tracking and Tracing of Medicines – a structural unit of the public legal entity “Analytical Expertise Center” of the Ministry of Health provides them with labels with 2D Data Matrix codes.
- In situation when the medicines are marked:
When medicines marked by the manufacturer with 2D Data Matrix codes are imported, importing companies request an electronic file with these codes from the manufacturer and place it in the DVTIS system.
Current situation
Currently, work is underway to draw up and approve regulatory documents. In this regard, the procedure for importing medicines and medicinal products into Azerbaijan remains the same. New legislative projects related to the implementation of the system are being prepared, including changes to existing legislative acts.
Our experts will continue following the journey of Azerbaijan towards enhancement of the track and trace system (DVTIS). However, if you need more information regarding track and trace regulatory compliance in Azerbaijan, schedule a free consultation with our expert >> communication@softgroup.eu
