About the Agency

Medicines and Medical Devices Agency of Serbia was founded by the Law on Medicines and Medical Devices (Official Gazette of the Republic of Serbia No. 84/04 and 85/05 – another law). Acting Director of the Agency is Sasa Jacovic, M.D.sp.

Resources and properties for the Agency establishment and operation commencement consisted of the resources and properties of the Pharmacy Institute of Serbia which, by this law, stopped existing.

The monograph contains a brief description of duties within the scope of work and achievements that the agency has made in the past.

You can download the Monograph HERE

Our mission is to contribute to the achievement of the basic human right to access to quality, safe and effective medicines and medical devices, as well as to promote and improve human and animal health through:

• issuing permits for placing on the market only high-quality, safe and effective medicines and medical devices,
• providing adequate information, so that the use of these medicines and medical devices is safe and rational,
• quality control of medicines and medical devices, which is in compliance with all national regulations and international standards,
• organized and continuous monitoring of adverse effects of medicines and medical devices

Our vision is to be a modern, efficient and socially responsible institution, which will become a leader in the region of Southeast Europe.

We implement our vision through effective and efficient processes within the framework of the management system, in accordance with the requirements of ISO 9001, ISO 14001 and ISO 27001, WHO guidelines on the implementation of quality management systems for national regulatory authorities as follows:

• we establish and maintain high standards in the process of document assessment, quality control and provision of adequate information, applying an approach based on expert-scientific postulates and risk assessment,
• we apply the principles of good regulatory practice: legality, consistency, independence, impartiality, proportionality, flexibility, certainty, efficiency, transparency
• we continuously learn and develop the competencies of our employees,
• we establish and maintain our long-term strategic priorities and development goals
• we adjust the mechanisms for responding in crisis and emergency situations so that quality, efficiency and safety remain mandatory conditions for the use of medicines and medical devices
• we continuously improve the management system, with the ultimate goal of improving our services, meeting applicable requirements and positive performance in environmental protection, including pollution prevention and commitment to compliance obligations,
• we recognize business risks and implement actions to reduce their impact on work, especially regarding confidentiality, integrity, availability and clarity of information.
• we establish and maintain high standards in communication with employees and interested parties, monitor and improve the satisfaction of users of our services
• we develop an organizational culture and a recognizable image, taking into account the security of the information we have at our disposal, as well as the information we market and
• we follow the leadership role of management in implementing the vision.

The Agency pays special attention to the protection of information assets, both its own and those of clients and other stakeholders, in order to achieve the highest degree of security for confidentiality, integrity and availability of information. The Agency performs its business activities with integrity and compliance with the applicable legal regulations related to the operation of the Agency, and in particular to the compliance with the rules for the protection of business secrets, copyright and license rights, as well as the protection of personal data.

We believe that we can respond to all challenges with our own strength. Our work is based on four basic principles:

• social responsibility – as an institution, we are committed, in the first place and to the greatest extent, to the preservation of human and animal health, but also to the protection of the environment through pollution prevention. We are responsible towards the social community, service users, employees and founders. We are committed to meeting all applicable stakeholder requirements.
• leadership – we set high standards with our work, to be a support for all stakeholders regarding public health by improving knowledge and skills, as well as to ensure the full implementation of the vision with modern management.
• trust – our further development is based on improving mutual trust with clients, through joint work and transparency in work, as well as on strengthening trust in our own human resources.
• quality – we are committed to achieving the highest quality of services, in order to achieve additional value for users, partners, employees and other stakeholders.

Activities carried out in the Agency refer to the operations preceding the issuance of marketing authorizations and the activities carried out upon the marketing of medicinal products and medical devices.