During the visit, the delegation from the Analytical Expertise Center visited the Turkish Medicines and Medical Devices Agency (TİTCK); “TC Health,” a company that played a key role in establishing the technological infrastructure and developing the technical solutions for Turkey’s Pharmaceutical Track-and-Trace System (İTS); and “Selçuk Ecza Deposu,” one of Turkey’s largest pharmaceutical wholesale enterprises. During the meetings, views were exchanged regarding the mechanisms implemented in Turkey for tracking the movement of medicinal products from manufacturer to end-consumer, ensuring transparency in the pharmaceutical supply chain, facilitating digital data exchange, and effectively managing the relevant information systems.

During the meetings, discussions focused on organizing information exchange among the various stakeholders of the pharmaceutical tracking and tracing system, ensuring data accuracy and integrity within the system, monitoring the movement of medicines, and enhancing risk management and control mechanisms.

One of the key outcomes of the visit was the drafting of a memorandum of cooperation between the Analytical Expertise Center and the Turkish Medicines and Medical Devices Agency (TİTCK). Plans are in place for the parties to sign the finalized draft in the near future following mutual agreement. The signing of the memorandum is expected to create new opportunities for cooperation in areas such as pharmaceutical tracking and tracing the regulation of pharmaceutical product circulation, the application of digital technologies, the exchange of data and expertise, and the further strengthening of the institutional framework for collaboration in this field.

The Azerbaijan was represented at the event by Shirin Shahbazov, Head of the Import-Export Department for Medicinal Products at the Analytical Expertise Center of the Ministry of Health.

We note that the retail prices of medicines in Azerbaijan are regulated and approved by the Tariff (Price) Council. Nevertheless, acting on the information circulated in the media, the Analytical Expertise Center investigated the matter and took appropriate measures in accordance with legislative requirements.

The investigation determined that the pharmacy selling “Selsept 500 mg (50 tablets)” for 123.02 AZN had not committed any violation of the law. The maximum retail price established by the Tariff (Price) Council for this medication is 123.02 AZN. It has been determined that the sale of the medication “Selsept 500 mg (50 tablets)” to a citizen for 67 manats and 60 qapiks took place at a pharmacy owned by “ZEYTUN PHARMACEUTICALS” LLC, located at 92 Samad Vurgun Street, Nasimi District, Baku.

Based on media reports and available facts, and referencing the state registry extract from the Ministry of Justice of the Republic of Azerbaijan,  the Analytical Expertise Center responsible staff has been conducted an unscheduled inspection of this mentioned pharmacy.

The inspection revealed that the medicinal product “Selsept 500 mg (50 tablets)” is an immunosuppressive drug used to prevent organ rejection following kidney, heart, or liver transplantation and included in the list of essential medicines provided free of charge by the state to persons with disabilities for outpatient use.

As part of the inspection, a written statement was obtained from the person in charge of the pharmacy. According to the statement provided, the drug offered for sale did not belong to the pharmacy itself but to a close relative of an employee. İt was surplus medicines and sold at the pharmacy at a reduced price because (it did not meet requirements).

During of the an investigation was determined that this practice violated current legislation. Furthermore, the inspection revealed other irregularities regarding non-compliance with regulatory legal acts at the pharmacy.

In connection with the identified violations, a protocol regarding the administrative offense was drawn up pursuant to Article 221.1 of the Code of Administrative Offenses of the Republic of Azerbaijan, and appropriate measures prescribed by law were taken.

The Analytical Expertise Center reiterates that inquiries from citizens and information circulated in the media are carefully investigated; where violations of the law are identified, prompt oversight measures are implemented, and the matter is addressed in accordance with the law.

At the same time, media representatives are requested to verify the official position before publishing information related to the healthcare sector particularly regarding matters within the purview of the Analytical Expertise Center. This ensures the public is accurately informed and helps prevent the formation of misconceptions. We remind that citizens may contact the Analytical Expertise Center regarding illegal activities, suspicious medicinal products, or other violations at private medical facilities and pharmacies via the following channels:

• “Single Window” sector;
• Hotline: (012) 596 05 20;
• E-mail: aem@pharma.az;
• The “Inquiries” section of the www.pharma.az website.

All incoming inquiries are investigated in accordance with legislative requirements; where necessary, unscheduled inspections of the relevant medical and pharmaceutical facilities are conducted, and measures prescribed by law are taken.

Relevant administrative protocols were drawn up regarding the identified violations in accordance with Articles 215.4, 221.1, 452.3, and 452.4 of the Code of Administrative Offenses of the Republic of Azerbaijan.

owning extensive pharmacy chains. The meeting was organized in response to deficiencies identified by the specialists of the Analytical Expertise Center in the use of the Tracking and Tracing System for medicinal products during the circulation of medicines.

During the meeting, participants were provided with detailed information on the most significant issues currently observed in the use of the System. Discussions also focused on the key measures that should be implemented to prevent serious non-compliance and operational deficiencies in the future. The discussions covered both pharmaceutical wholesale enterprises and the pharmacies operating under their management.

As part of the meeting, the purpose and objectives of the Tracking and Tracing System were once again explained in detail to the company executives. It was emphasized that wholesale pharmaceutical companies, as one of the key links in the supply chain from the manufacturer to the end consumer, must ensure the accurate and proper use of the System. Company representatives were informed that establishing effective internal control mechanisms to ensure compliance with regulatory requirements and the uninterrupted exchange of data is one of their highest priorities.

The meeting also addressed the current non-compliance issues identified in the companies’ use of the System, the potential serious consequences of such shortcomings, and the measures required to eliminate them. The companies were instructed to reiterate to all subordinate enterprises the importance of using the Tracking and Tracing System correctly and in full accordance with the established guidelines.

Of these inspections, 58 were carried out at pharmacies located in Baku, while 10 took place at pharmacies in other cities and districts across the country. A total of 56 inspections were scheduled, and 12 were unscheduled.

Based on the inspection results, various violations were identified in 10 pharmacies.

Due to non-compliance with the required storage conditions, 38 boxes of medicinal products representing 11 different items (SKUs) were removed from sale.

In addition, 1 administrative protocol was drawn up under Article 215.4 of the Code of Administrative Offenses of the Republic of Azerbaijan, and 9 administrative protocols were issued under Article 452.3.

During the meeting, agreements were reached on the following key issues:

1. In order to strengthen cooperation between the State Customs Committee and the Ministry of Health and to ensure the mutual integration of permits issued in relation to medicines and medical devices, reciprocal access to the electronic systems of both institutions will be provided. In accordance with the instructions of the Minister of Health to the subordinate institutions, access to the existing electronic information systems of the relevant bodies under the Ministry of Health will be granted to the respective structural units of the State Customs Committee.
2. To address existing and potential issues related to medicines and medical devices, it was agreed to establish working groups comprising specialists and other relevant officials and to ensure effective cooperation between these groups. The parties also reached a mutual agreement on conducting training sessions and seminars for specialists of both institutions in the relevant areas of activity.
3. The State Customs Committee and the Ministry of Health agreed to introduce the necessary amendments to the legislation within their respective areas of competence and to strengthen the regulatory framework governing their common areas of activity.

The meeting was also attended by the management of the Analytical Expertise Center of the Ministry of Health. The parties agreed to continue efforts aimed at further expanding cooperation and coordinating joint activities in order to achieve the objectives set forth.

The Republic of Azerbaijan was represented at the forum by Rena Huseynova, Chief Consultant of the International Cooperation Department of the Ministry of Health of the Republic of Azerbaijan; Azer Hasanov, Head of the Registration and Expertise of Medicines Department of the Analytical Expertise Center; and Rafiga Ibrahimova, Expert of the Pharmacovigilance Department.

During the forum, participants discussed modern approaches to the registration and assessment of medicines, pharmaceutical market regulation, ensuring the quality and safety of medicinal products, improving pharmacovigilance systems, as well as prospects for the development of regional and international cooperation in the healthcare sector.

The event programme also included the exchange of best practices, discussions on leading international approaches, and the establishment of new professional contacts aimed at strengthening cooperation between relevant institutions and expert communities.

The participation of the Azerbaijani delegation in the V International Pharmaceutical Forum of Uzbekistan will contribute to the further development of bilateral and multilateral cooperation in the fields of healthcare and pharmaceuticals, expansion of professional dialogue, exchange of experience, and strengthening of partnership relations between Azerbaijan, Uzbekistan, and other participating countries.

One of the inspections took place in Baku, while 55 were conducted in pharmacies located in other cities and districts of the republic. Out of the inspections conducted, 55 were scheduled, and one was unscheduled.

As a result of the inspections, various violations were identified in 18 pharmacies. Administrative protocols were drawn up regarding the identified violations in accordance with Articles 452.1 and 452.3 of the Code of Administrative Offenses of the Republic of Azerbaijan.

During the meeting, views were exchanged on the current situation in the field of medical devices and biologically active food supplements, international experience in this area, as well as opportunities for mutual cooperation. The parties discussed relevant areas of activity, issues related to quality and safety, and existing regulatory mechanisms governing the circulation of such products.

At the same time, the representatives were provided with detailed explanations regarding the state registration of medical devices and biologically active food supplements in the Republic of Azerbaijan, the expertise procedures, required documentation, as well as the requirements of current legislation related to the import of these products into the country. It was emphasized that the circulation and import of products within the country must be carried out strictly in accordance with the requirements of applicable regulatory legal acts.

Overall, the meeting was held in a businesslike and constructive atmosphere, and the parties exchanged useful views on matters of mutual interest.