About the Agency

Information Technology

The increasing use of information technologies and the advancement of Internet provide powerful tools and place them at the disposal of citizens, government bodies, large and small enterprises around the world.

Information technology has great significance for the performance of basic activities in the Medicines and Medical Devices Agency of Serbia (ALIMS).

Special attention is given to the following:

• Development and management of information technology,
• Development, maintenance and improvement of the integrated business information system of the Medicines and Medical Devices Agency of Serbia,
• Maintenance of IT equipment, hardware upgrades and reconfiguration of hardware solutions,
• Ensuring protection of the information system and computer network,
• Ensuring technical compatibility of the information infrastructure,
• e-Business development of the Medicines and Medical Devices Agency of Serbia in accordance with the e-Government project of the Republic of Serbia,
• Development of Intranet and website of the Medicines and Medical Devices Agency of Serbia.

Information System of the Agency

Information system of the Medicines and Medical Devices Agency of Serbia is the basis for storing data on medicinal products and medical devices in digital format, easier data handling, as well as easier review of existing data.

The main objective of the Medicines and Medical Devices Agency of Serbia information system is to provide simple and fast performance of activities related to planning, research, decision-making in the field of regulation of medicinal products and medical devices.

Information system of the Medicines and Medical Devices Agency of Serbia is an integrated information system that includes the following subsystems:

1. Laboratory Information System and master data on medicinal products,
2. Electronic Management System for regulatory documentation,
3. Agency Digital Information System
4. Accounting and Finance System
5. Personnel System

The Laboratory Information System and master data on medicinal products are an integral part of the Quality Management System. Several applications have been developed within the Laboratory Information System for business processes of the Medicines and Medical Devices Agency of Serbia National Control Laboratory, thereby enabling a full IT support in the daily work of NCL. The information system is based on relational database ORACLE 10g, which is one of the most advanced information technologies in the world when it comes to information systems. Applications for all business functions in the Laboratory Information System are adapted for the actual activities and are based on existing standard operating procedures. Therefore, Laboratory Information System monitors all requirements of the SRPS ISO17025:2006 standard, it is a part of the QMS and necessary factor in further quality improvement of provided services. Quality control of medicinal products and medical devices is informatically supported through this information system and includes: defining of services and analysis development, analysis implementation, control of results and issuing certificates of analysis.

Electronic Management System for regulatory documentation is based on the following:

1. 4-tier architecture,
2. ORACLE 11g Database (DB link and Gateways),
3. EMC Documentum 6,
4. myProcess Application Server – JBoss and Apache,
5. Web browser – Internet Explorer 7 and 8.

All activities of the Agency, including integrated quality management, and IT support are informatically supported within the Electronic Management System for documentation.

The new information system for medical devices and drugs, based on eServices of the highest level of sophistication, is integrated with the eGovernment portal and enables the clients of ALIMS and EOS, i.e. the pharmaceutical industry of the Republic of Serbia, to submit all requests with accompanying documentation in electronic form, as well as two-way interaction and exchange of information for the process of clinical trials for drugs and medical devices.

For all digitized procedures, the IT solution enables: two-way interaction and online transaction between the applicant (external users) and the employees of ALIMS and EOS (internal users) who evaluate the request, in terms of the possibility of giving deficiencies, and supplementing the documentation by the user, as and personalization, i.e. proactive eServices.

The introduction of a new information system based on the digital transformation of business processes affects the more efficient operations of ALIMS, EOS and the pharmaceutical industry, i.e. the economy of the Republic of Serbia, through a significant reduction in costs, faster resolution of the requirements of the pharmaceutical industry, as well as faster provision of information about quality, efficient and safe medicines and medical supplies to the citizens of the Republic of Serbia…

The necessary technical conditions that the pharmaceutical industry, i.e. license holders, should have are just the existence of the Internet and the Microsoft Office package.

Every request generated by filling out the application form on the portal must be digitally signed by the applicant, as well as the documents sent with the request. During the life cycle of the case, the applicant can constantly monitor the status of the submitted application.

The ADIS system includes:

ADIS Medicines

ADIS Medical devices

ADIS Technical Support

Accounting and Finance System and Personnel System are based on the following:

Client – Server Architecture
SQL – 2005 Standard Database

The main modules are as follows:

Financial-accounting System

Subsystems for finance – accounting, bookkeeping, warehouse operations.

Personnel Information System

Subsystems for personnel and records on working hours.