Integrated system for monitoring the market of medicinal products (SI-ZSMOPL)

ZSMOPL - legal requirements

Under the proposed amendments to the Act of September 6, 2001, the Pharmaceutical Law, entrepreneurs trading in medicinal products, reimbursed foodstuffs for particular nutritional uses, and reimbursed medical products, as of January 1, 2018, will be obliged to transfer the data indicated in these regulations to the Integrated System Monitoring the Trade in Medicinal Products (ZSMOPL) of the Ministry of Health. This obligation will be exercised by all entities involved in the circulation of medicinal products, reimbursed foodstuffs for particular nutritional uses and medical devices on the territory of the Republic of Poland.

Entities participating in the trading of the above-mentioned under the threat of a financial penalty, are obliged to prepare their IT systems for reporting data using the Integrated Monitoring System for Trade in Medicinal Products while maintaining the specification of requirements, structures, and data formats available on the website of the Ministry of Health.  The detailed specification of requirements »

According to earlier plans, the obligation to send messages to the Ministry of Health was to enter into force on July 1, 2017. The ongoing work on the construction of the ZSMOPL central system, the lack of final reporting requirements, and the very short time left for interested parties to be able to prepare for the implementation of such an obligation, caused the deadline to be postponed to the beginning of 2018.

Draft amendments to the Pharmaceutical Law (amendment to Section 72a of the Act of September 6, 2001) introduce solutions to facilitate and relieve all entities involved in the sale of medicinal products, reimbursed foodstuffs for particular nutritional uses, and medical devices in the territory of the Republic of Poland. Reporting data on all medicinal products once a day is burdensome for reporting entities, e.g. for financial and human resources reasons, where it is required to modify systems and hire additional employees. The draft provides that, by the disposition of a regulation, a list of active substances with psychoactive effects contained in medicinal products, issued without a prescription will be specified, which will be subject to daily reporting. The draft also provides for the regulation of the issue of submitting data and information to the Integrated Monitoring System for Trade in Medicinal Products by parallel importers, while simplifying and reducing the scope of data provided for them. Currently, the issue of parallel importers in this area is not regulated by law, which is associated with many inaccuracies in the rules of operation of enterprises.

Problems related to the obligation to report to ZSMOPL and the need to postpone the reporting obligations to January 1, 2018, with the simultaneous limitation of data and information submission, were reported by representatives of all entities involved in the sale of medicinal products. The draft act also introduces solutions aimed at preventing one entrepreneur from carrying out several types of economic activity in the scope of which he may purchase medicinal products. This action is necessary to stop the export of medicinal products outside the territory of the Republic of Poland by entrepreneurs who simultaneously run a pharmaceutical warehouse and perform medical activities.

The Act requires that entities report Trade and Stock Messages, Shortage Report Messages, and Delivery Scheduling Messages. The daily obligation of reporting the turnover, stocks, shortages of medicinal products, and planning of deliveries will apply to business entities running generally accessible pharmacies, pharmacy outlets, company pharmacies, business entities running pharmaceutical wholesalers within their structure, medical entities running a hospital pharmacy within their structure, medical entities running pharmacy departments within their structure, and even medical entities that do not run a pharmacy or a pharmacy department, but participate in the sale of medicinal products, reimbursed foodstuffs for special nutritional uses and reimbursed medical products

The reporting obligation applies to transactions with pharmaceutical products specified by the Ministry of Health, both within the Polish pharmaceutical market and those relating to import and export to and outside the European Union.

SI-ZSMOPL for SAP

SI-Consulting has the greatest experience in Poland in the implementation of solutions for SAP systems in the field of generating messages to the Ministry. Our clients are over 100 business entities that, using the JPK Generator and JPK eTransfer tools, known as the standard SAP Add-on - SAF-T, fulfill the reporting obligation of the Standard Audit File. Having gained experience in the preparation and delivery of such solutions, we have prepared another SI-ZSMOPL solution and eTransfer ZSMOPL, which meets the requirements of clients from the pharmaceutical industry dealing with trade in medicinal products. Five people are currently working on the solution, directly and exclusively involved in product development.

SI-ZSMOPL for SAP enables independent service and provides the functionality necessary to meet the requirements of the Pharmaceutical Law in the field of reporting to the ZSMOPL system of the Ministry of Health. The application fulfills the requirement of reporting by the client both as the responsible entity (PO) and as a pharmaceutical wholesaler (HU). Data on the delivery plan, suspension, resumption, and completion of deliveries - reports the Responsible Entity. Data concerning wholesale and retail turnover are reported by the Pharmaceutical Wholesaler and the Responsible Entity, while data concerning the reporting of shortages of medicinal products on the market are reported by the Pharmaceutical Wholesale Company. The entity identification refers to the reporting entities for which individual products that are subject to the reporting obligation are assigned in the system. Contractor data necessary for reporting are downloaded from the SAP system (e.g. REGON, Name per KRS / CEIDG) and are stored in Basic Data and customer classification in the SAP System.

SI-ZSMOPL ensures the reconstruction of the chronological order of all transactions for a given Reporting Entity. The calculation for the material index and the product batch, broken down into available to the customer and blocked inventory, is performed for the inventory of all products processed in a given transaction. The inventory is valued after the quantity has been calculated - based on sales prices collected from SAP. Missing price causes a reporting error. As part of a separate transaction, the system provides support for target and intervention import reporting. The SI-ZSMOPL system enables the user to supplement the data necessary for the report with numerical data and descriptive data (e.g. the reason for the inventory difference, the reason for the destruction of the product, the reason for the suspension of deliveries). The solution enables data completion with the use of defined dictionaries. SI-ZSMOPL includes mechanisms to verify the completeness and correctness of the generated report before sending it to the ZSMOPL System. In the event of identifying incompleteness or irregularities of the generated report, the system enables sending the correct part of the report to the ZSMOPL system and at the same time sending an appropriate notification to the user. The notification for the user indicates the places where an incompleteness or irregularity in the report was identified (provided that error messages are correctly handled by the ZSMOPL system of the Ministry of Health). After sending the report to the ZSMOPL system, the SI-ZSMOPL solution remembers the identifier assigned by the ZSMOPL and the processing status. The solution allows the user to send a corrected report. SI-ZSMOPL has the function of searching for a given report based on given criteria, in particular, report status (e.g. incorrect/correct), report ID, report type, report date, entity sending the report, the product the report concerns, etc.) and the re-function generate and send a corrected report. The SI-ZSMOPL application automatically marks incorrect reports that have not passed internal validation. The solution allows you to handle reports that have not passed formal validation by the ZSMOPL system (information via webservice). The user has the option of manually marking these reports as incorrect, e.g. reports that have not been qualified as correct on the ZSMOPL portal (business validation). After correct sending of the wrong report to the ZSMOPL system, the status of this report is changed. XML files containing incorrect reports are stored by the system with an appropriate annotation in the file metric. In addition to the possibility of correcting the report by the user, the application has the function of automatic correction of reports for defined cases, e.g. supplementing the invoice number in the purchase report, when the invoice arrives late. Other cases requiring correction are a collective sales invoice, comments on warehouse movements (e.g. inventory), changes in the target import database. The system enables full automation of sending messages. The application enables dialogue or background processing, and the obtained data is stored in client tables. We also can analyze data (presentation, review of logs from the generation stage), validate them (ensuring a format compliant with the specification of the Ministry of Health), create an XML file based on it (compliant with the specification of the Ministry of Health) and send it (electronic signature of the XML file, sending to the gateway of the Ministry of Health, logging the feedback status with the data enabling the sending of a corrected message) - using the dedicated

SI-ZSMOPL solution.

SI-ZSMOPL - project realizations

The new requirements related to the need to report the trade in medicinal products mean that pharmaceutical entities must adapt their SAP systems to generate and send data to ZSMOPL in the form expected by the Ministry of Health.

SI-Consulting provides its clients from the pharmaceutical sector with a full range of services that enable them to meet new legal requirements. The SI-ZSMOPL application is a solution installed on the customer's SAP system, which enables the generation of legally required messages, their automatic sending to ZSMOPL, and handling of feedback messages. When implementing the SI-ZSMOPL system, based on transaction data, the necessary information is automatically collected regarding, among others, deficiencies in the access of medicinal products, each purchase, and sale of products and planned deliveries. The automatically generated XML files are sent to the ZSMOPL system of the Ministry of Health, following the communication procedure specified in the draft regulation of the Minister of Health on the minimum organizational and technical requirements for the Integrated Monitoring System for Medicinal Products.

The implementation process of the Integrated Monitoring System for Medicinal Products, prepared by SI-Consulting, was divided into two stages. The first is to conduct a pre-implementation analysis, the result of which is the preparation of the Implementation Concept. For some of the clients, there is a need to modify the processes of inventory and material index management for the needs of ZSMOPL reporting. The subject of the Pre-implementation Analysis are both technical aspects (the scope of data in the existing SAP modules, customer extensions important in terms of ZSMOPL, etc.) and the analysis of business processes - relations and data separation between entities, logistic processes important for ZSMOPL reporting, and sometimes also additional integration with external systems. Its main purpose is to verify the availability and quality of the necessary data to generate all necessary types of messages.

SI-Consulting is open to any suggestions and ideas related to the improvement and ergonomics of the solution. When, as a result of the Analysis, it turns out that it is necessary to make additional extensions and modifications in the SI-ZSMOPL application, such a solution will be taken into account and may be included in the standard of the target solution for other SI-Consulting clients using the SI-ZSMOPL solution. SI-Consulting supports its clients in the development of their client systems, in particular the SAP system for the needs of ZSMOPL in the field of target and intervention import reporting.

The initial configuration and adaptation of the Application to the client's specificity allows the user to generate data in the required XML format by extracting relevant data from the MM, SD, FI modules. Implementation works include the installation of SI-ZSMOPL and eTransfer SI-ZSMOPL software, configuration following the client's specificity, and the requirements of the Implementation Concept. Customer-specific development begins as soon as possible if its need has been identified at the analysis stage. We provide support during the tests of the solution and the process of its validation. The access to the ministerial ZSMOPL System is configured together with the client, and SI-Consulting consultants integrate the eTransfer SI-ZSMOPL system with the ZSMOPL platform of the Ministry of Health.

The preliminary framework schedule assumes the execution of the Pre-implementation analysis within no more than 3 weeks from the date of commencement of works. Installation, configuration, and possible development usually do not take more than 4 weeks, although if all necessary data is available in the customer's SAP system, this time can be significantly reduced. Taking into account the GxP requirements, system tests and validation usually last from 2 to 4 weeks. In addition to the team of developers and analysts, SI-Consulting offers 5 consultants who can carry out several Implementation Analysis and SI-ZSMOPL system implementation projects simultaneously.

The SI-ZSMOPL application was prepared in the ABAP Objects technology. As part of the license fee and maintenance, SI-Consulting provides full-service care, including adaptation to the changing requirements of the Ministry of Health. By choosing the SI-ZSMOPL solution, we receive a guarantee of removing errors and faults in the software, adapting the solution to changes in legal provisions in the field of ZSMOPL, systematic provision of functional improvements, access to the service reporting portal, and to the necessary materials intended for: constantly updated job instructions, documentation system, documentation of changes, distribution files with the new software version.

The eTransfer SI-ZSMOPL software was written in Java 8 (Spring) technology and runs in a servlet container (e.g. Tomcat) in a JEE7 compatible application server (e.g. WildFly or JBoss EAP). The main functionality of the software is receiving messages from the SI-ZSMOP system and transferring them to the target ZSMOPL system of the Ministry of Health through the available WebService (SOAP). By separating the data transfer function into a separate application, we ensure the security of the SAP environment, which will not be exposed directly to the external Internet. The messaging application works in the DMZ without exposing other systems to unauthorized access from outside. The eTransfer SI-ZSMOPL application ensures compliance of sent and received messages (SOAP + a special type of WS-Security authentication required by the Ministry of Health) as well as diagnostics and analysis of sent messages by logging into files and archiving messages. The application is delivered in two forms: ready distribution in a servlet container (Tomcat) and as a WAR file ready for deployment on another application server.

SI-Consulting has prepared a questionnaire that allows shortening the process of analyzing the specificity of the client's SAP solution and to prepare an offer in a flash. The survey can be found at:

SI-Consulting offers its clients two license-models to choose from. In addition to the standard license agreement, the subscription agreement is noteworthy, consisting of the acquisition of rights to use the software for a nominal monthly fee. Therefore, the initial costs of obtaining the solution include only the costs of implementing the SI-ZSMOPL system. In this way, our clients are not forced to cover single significant costs, which are broken down over a long period, while at the same time guaranteeing the constant development and adaptation of the application to the changing requirements of the Ministry of Health.

The ambition of SI-Consulting is to provide the most ergonomic solution supporting the process of automatic generation of marketing messages for medicinal products at an affordable price acceptable to customers. Our goal is to meet customer needs, maintain and develop the SI-ZSMOPL solution, as we do in the case of SAF-T (JPK Generator & eTransfer JPK).

It would seem that there is still a lot of time until January 1, 2018. However, taking into account the holiday period, as well as the frequent need to conduct the tender process and the expected increase in interest in the solution at the end of 2017, when the time is pressing, it is worth considering that the entire process of preparing the ZSMOPL solution should be started now

Przydatne linki:

Pobierz plik

System monitorowania obrotu produktami leczniczymi specyfikacja komunikatow/

Komunikatów sprawie zintegrowanego systemu monitorowania obrotu produktami leczniczymi ZSMOPL

Projekt ustawy zmieniającej ustawę o zmianie ustawy – Prawo farmaceutyczne oraz niektórych innych ustaw

Projekt ustawy zmieniającej ustawę o zmianie ustawy – Prawo farmaceutyczne oraz niektórych innych ustaw

Webinarium ZSMOPL dla systemu SAP

Oprogramowanie SI-ZSMOPL