Under the proposed amendments to the Act of 6 September 2001 (Pharmaceutical Law), entrepreneurs trading in medicinal products, reimbursed foodstuffs for special nutritional purposes and reimbursed medical devices, as of 1 January 2018 will be obliged to submit the data indicated in these regulations to the Integrated System for the
Monitoring of Trade in Medicinal Products (ZSMOPL) of the Ministry of Health. This obligation will apply to all entities participating in trade in medicinal products on the territory of the Republic of Poland, reimbursed foodstuffs for special nutritional purposes and medical devices. Entities involved in the trade of medicinal products, reimbursed foodstuffs for special nutritional purposes and medical devices are obliged, under financial penalty, to prepare their IT systems for reporting data by means of the Integrated System for the Monitoring of Trade in Medicinal Products, while maintaining the defined specification of requirements, structures and data formats, which is available on the website of the Ministry of Health.
Entities involved in the trade of medicinal products, reimbursed foodstuffs for special nutritional purposes and medical devices are obliged, under financial penalty, to prepare their IT systems for reporting data by means of the Integrated System for the Monitoring of Trade in Medicinal Products, while maintaining the defined specification of requirements, structures and data formats, which is available on the website of the Ministry of Health.
Software features
SI-ZSMOPL application developed by SI-Consulting is a dedicated tool prepared for pharmaceutical companies that use the SAP System to support logistics processes in their organisation in order to fully automate the preparation and transmission of ZSMOPL messages to the Ministry of Health. The solution was made in ABAP Objects technology and consists of three transactions responsible for configuration, data generation and administration of generated messages.
One of the most important options in an administrative transaction is the ability to generate an XML file for data generated earlier. This file is then automatically signed and sent to the servers of the Ministry of Health in the eTransfer SI-ZSMOPL module, and the feedback status of the communication and the data necessary for possible corrections are transferred to the administrative transaction. Thus, the involvement of the system users is limited to an analysis of the correctness of the messages adopted by the Ministry of Health.
e-Transfer
SI-ZSMOPL application is used to generate messages in XML format, which can be downloaded manually into the ZSMOPL system of the Ministry of Health using Internet tools provided by the Ministry. It places the generated XML message files in an appropriate folder, which are automatically sent to the Ministry’s ZSMOPL system using the dedicated eTransfer application, while registering the statuses and possible errors of sending them to the Ministry’s system. This means that the eTransfer SI-ZSMOPL application fully automates the process of transferring messages to the Ministry. It is possible to purchase a license only for the application and manually operate the process of downloading message files in XML format to the Ministry’s ZSMOPL system.
Separation of the data transfer function into a separate application:
- enables security - the SAP environment will be exposed directly to the external Internet. The application sending messages works in the DMZ without exposing other systems to unauthorised access from outside.
- Compatibility with the required data protocol - the application ensures compatibility of sent and received messages (SOAP + special type of WS-Security authentication required by the Ministry of Health).
- Diagnostics and analysis of transmitted messages - logging into files and archiving messages.
The application is provided in two forms:
- Ready-made distribution in a servlet container (Tomcat)
- WAR file ready for implementation on another application server.
In both cases, we provide installation instructions and user manuals.
