During the inspections, violations were found in 4 pharmacies. Protocols were drawn up in accordance with Articles 452.1 and 452.3 of the Code of Administrative Offenses of the Republic of Azerbaijan.

During the event, lectures were presented on the identification of impurities in medicines and pharmaceutical substances based on the monographs of the United States Pharmacopeia. Topics included methods of analysis, equipment used, applicable standards, and a newly developed platform related to nitrosamine impurities.

As part of the visit, a short familiarization tour was organized to the newly established “Pharma Park,” located at the Agency for the Development of the Pharmaceutical Industry under the Ministry of Health of the Republic of Uzbekistan.

As part of the visit, Larisa Kopp, Deputy Head of the Pharmacovigilance Department at the Paul Ehrlich Institute and a member of the mission, visited the Analytical Expertise Center (AEC). During her visit, the effectiveness of the pharmacovigilance system for medicines and vaccines in the country was assessed according to WHO standards, particularly using the WHO Global Benchmarking Tool (GBT).

During the meeting with the staff of AEC’s Pharmacovigilance Department, both parties discussed issues of mutual interest, as well as optimal solutions to challenges arising in the process.

The investigation revealed a packaging defect: the expiration date was initially printed as September 14, 2023, but was later altered to September 14, 2028, using a sticker.

In accordance with Clause 1.3 of the “Rules for the Recall of Medicinal Products,” approved by Decision No. 460 of the Cabinet of Ministers of the Republic of Azerbaijan dated November 27, 2019, the Analytical Expertise Center carried out a review. As a result, the specified batch has been recalled, and its import into the country, as well as wholesale and retail sales within the country, have been prohibited.

The conference was opened by Fergus Auld, Ambassador Extraordinary and Plenipotentiary of the United Kingdom of Great Britain and Northern Ireland to our country, who delivered a keynote speech in which he emphasized the importance of the conference for our country in strengthening mutual cooperation in the pharmaceutical field.

At the conference Analytical Expertise Center of the Ministry of Health, which regulates the pharmaceutical sector of our republic, is represented by Deputy Director General Rafik Khudaev.

• Periodic Safety Update Report (PSUR) — According to the List (specifying submission deadlines and frequency) prepared in line with Sections 16.2.8 and 16.2.8.1 of the Rules, available on the Analytical Expertise Center’s official website: (https://pharma.az/en/uncategorized-en/attention-holders-of-the-registration-certificate-of-medicines/).
• Risk Management Plan (RMP) — As required by paragraph 16.2.7 of the Regulations and paragraph 7.3 of the Good Pharmacovigilance Practice guidelines.
• Pharmacovigilance system master file (PSMF) — According to paragraph 7.1.13 of the Regulations, the MAHs must submit the Pharmacovigilance System Master File to the Analytical Expertise Center within 7 (seven) working days upon request.

Additionally, we inform you that the Tariff Council of the Republic of Azerbaijan, in its Decision No. 10 dated December 5, 2023, has approved the tariffs for expert services related to pharmacovigilance documents submitted after the state registration of a medicinal product, which will enter into force on May 1, 2025 (https://pharma.az/tarifler/tarifl-r/).

Please note that if the MAHs do not comply with the requirements of the Regulations in a timely and proper manner, the Analytical Expertise Center has the authority to take measures in accordance with paragraphs 19.6 and 19.7 of the Regulations. In case of non-compliance with the requirements and if a violation is detected, the Ministry of Health will be immediately informed about this fact.  Depending on the nature of the violation, the Ministry will set a period of no less than 15 (fifteen) days and no more than 3 (three) months for the resolution of the violation. If the violation is not resolved and the required documents are not provided within the specified time, the state registration of the medicinal product will be revoked.

In this field, the quality, safety, and efficacy of medicines are ensured through the implementation of Good Manufacturing Practice (GMP) standards. In recent years, Azerbaijan has taken significant steps to align its pharmaceutical sector with these international requirements. One of these steps was the recent approval of the new GMP rules.

GMP rules ensure that medicines are produced with high quality and in a controlled manner. These rules cover production processes, infrastructure, equipment, personnel, laboratory testing, and documentation. The main goal of GMP is to deliver quality, safe, and effective medicines to the consumer – the patient.

The new GMP rules, which came into effect in April 2025, aim to eliminate existing gaps in the sector and accelerate the alignment with the requirements of the European Union and the World Health Organization. The main changes are as follows:

• Implementation of Real-Time Release Systems (RVBS) and Parametric Release – ensuring the quality of the product through continuous monitoring at all stages of production, not only through final testing.
• Strengthening the Risk-Based Approach – enterprises are required to proactively identify risks and take preventive measures.
• Increasing the Use of Electronic Documentation and Traceability – expanding the use of technological solutions to prevent counterfeiting and human errors.
• Emphasizing the Role of Quality Control Personnel (Qualified Person – QP) – their responsibilities will be more clearly defined.

 Who Benefits from These Changes?

• For Manufacturers – processes that provide greater transparency and access to international markets.
• For Exporters – recognition of medicines in European and other high-demand markets, enhancing competitiveness.
• For Consumers – production of safer, higher-quality, and more reliable medicines.

The successful implementation of GMP rules is possible not only through regulatory documents but also through ongoing training, audits, and public-private sector cooperation. The new rules provide significant opportunities for Azerbaijan’s pharmaceutical industry to integrate with international standards, which will bring long-term benefits to both the national economy and public health.

The purpose of the conference was to provide theoretical and practical knowledge on all stages of medical research – from idea development, data collection and analysis, to preparation and publication of scientific articles – to faculty members of medical educational institutions, employees of research institutes, and clinical researchers.

Renowned medical professionals, researchers, and speakers with international experience participated in the event.

Moderators of the conference included: Prof. Eldar Garayev – Head of the Department of Pharmaceutical Toxicology and Chemistry, Azerbaijan Medical University, Prof. Rauf Beylerov – Head of the Department of Pediatric Diseases I, AMU, Assoc. Prof. Dr. Orkhan Isayev – Honored Doctor of the Republic of Azerbaijan, Dr. Elmar Babayev, PhD – Clinical pharmacist, specialist in toxicology and biochemistry, member of the Royal Pharmaceutical Society of Great Britain, board member of Azerbaijan pharmclub.

The conference covered the following topics:

• “Where Medical Research Begins: Planning, Data Collection, Processing and Analysis / Scientific Writing and Ethics” – Dr. Marziya Mammadova, neurologist, senior researcher at the Clinical Neurophysiology Lab, Scientific Research Institute of Medical Rehabilitation; assistant at the Department of Neurology and Clinical Neurophysiology, Azerbaijan State Doctors’ Advanced Training Institute named after Aziz Aliyev; expert of the Ministry of Health; Director of “Health and Science Initiatives” LLC
• “Fundamentals of Good Clinical Practice (GCP)” – Dr. Jala Agayeva, PhD, expert in clinical research and GCP, medical safety specialist, Germany
• Pharmacovigilance as an Integral Part of Clinical Research – Farid Hasanov, Head of the Pharmacovigilance Department at the Analytical Expertise Center of the Ministry of Health; member of the International Society of Pharmacovigilance; national observer at the International Council for Harmonisation (ICH)
• “Study Design and Ethical Issues. The Role of Medical Associations in Clinical Research and Guideline Development” – Dr. Elshan Agayev, ENT specialist, allergist, clinical research expert; Deputy Chairman of the Azerbaijani Medical Workers Association in Germany (AMD)
• Experience of Health and Science Initiatives as a Contract Research Organization (CRO) – Dr. Marziya Mammadova

The conference featured interactive discussions and was enriched by presentations on digital platforms such as allinus.az, REDCap, Google Forms, SPSS, and R. This event marks an important step toward aligning medical research in Azerbaijan with international standards and enhancing local expertise in the field.

Recently, there have been cases in the media and social networks involving doctors conducting live broadcasts, and investigations are being carried out based on the relevant legislation. As a result of these investigations, warnings and penalties are applied. Additionally, Analytical Expertise Center informs doctors and clinic management about the Ministry of Health of the Republic of Azerbaijan’s Order dated December 29, 2011, “On the Approval of Ethical Guidelines for Physicians.” In Section VI of this order, it is stated that medical publications, doctors’ scientific forums, and their public appearances in the media should be in line with ethical standards, limited to objective scientific and practical information, and should not include elements of unhealthy competition, advertising, or self-promotion. The order also notes that doctors should not use their positions to promote the advertising or interests of legal or physical persons.

Shooting during surgeries can only be conducted for scientific and educational purposes, provided that all sanitary and hygienic rules are strictly followed and using technical equipment installed in operating rooms in accordance with sterilization requirements. Failure to comply with these rules and conducting filming with other equipment violates hygiene rules and creates favorable conditions for the spread of infections.

This activity is considered advertising under Article 29.1 of the Advertising Law of the Republic of Azerbaijan. According to Article 428.4 of the Code of Administrative Offenses of the Republic of Azerbaijan, officials who engage in the advertisement of unapproved treatment, prevention, diagnosis, and rehabilitation methods will be fined between 300 and 500 azn, and legal entities will face fines ranging from 1000 to 2000 azn.

Citizens are reminded that if they encounter any problems with private medical institutions or pharmacies, they can contact the AEC “Single Window” (Bir Pəncərə) system, the hotline (012 596 05 20), email at aem@pharma.az, or through the “Write Us” section on the pharma.az . In such cases, an investigation will be conducted, and if necessary, a decision will be made to carry out an unscheduled inspection.