e-Leki

Our offer is directed to the SAP system users, who are obliged, according to the Law on Medicinal Products, to submit reports about the medicinal products turnover.

The e-Leki system we propose, is our dedicated solution developed by the KBJ S.A. to allow for the fulfilment of the obligation of reporting the medicinal products turnover information by directly transferring it to the ZSMOPL system. Our offer consists of the following elements:

e-Leki software, including licence,
3-years of support and software upgrades,
Technical documentation and End User Guide,
Implementation of the e-Leki solution in your SAP system,
Support in the procedure of gaining access to the ZSMOPL evaluation in the production environment,
Training in the e-Leki, solution
Software developer's warranty

The above comprehensive package provides you with secure solution for the fulfilment of obligations to report information according to the guidelines issued by the Ministry of Health.

Why choose the e-Leki solution?

Guaranteed fulfilment of all obligations related to the reporting of data to the ZSMOPL.
Guaranteed support and software upgrades, including changes and new messages (in the case such are implemented by the Ministry of Health) with no additional licence fees.
The e-Leki solution is based on the proven and stable XML Studio platform, which is operationally used in more than 150 companies.
The KBJ specializes in providing Customers with software on the SAP platform. Over 10 years of experience has resulted in a number of solutions for some 300 thousand end users in companies employing a total of more than a million employees.
Guaranteed quality – while supplying e-JPK software in 2016, we have at the same time run several dozen implementation projects in over 100 companies. All Customers, regardless of the SAP System configuration and version, submitted the required declarations and reports in due time.

The e-Leki solution ensures:

Data transfer to the ZSMOPL directly from SAP system,
Sending of each message may be planned independently and performed automatically, also periodically,
Saving all the messages sent from the application,
Advanced configuration of the tool, global and in reference to particular messages,
Monitoring of the solution and the message sending status,
Full compatibility with the standard SAP authorization system,
Separation of the standard e-Leki software in the namespace /KBJ/ and the client's configurations, which guarantees the safe software upgrade,
Reporting functions.

Servicing the ZSMOPL messages:

According to the Law on Medicinal Products, the e-Leki solution supports all messages required by the Ministry of Health:

Message on Turnaround and Stock including information on the turnaround of medicinal products. The report is based on the materials movement, purchase and sales invoices, and optionally the data included in the QM (Quality Management) module,
Message of Shortages Notification including information about products ordered by the collaborating entities, which are not in stock for the moment,
Message on Planned Deliveries, including schedule agreements, orders, contracts.

Legal grounds

As of January 1^st, 2017, there came into effect new regulations of the Act of 6^th September 2001, Law on Medicinal Products, introducing new obligations in the area of providing information on the medicinal products turnaround for the obliged entities, entrepreneurs in the area of pharmaceutical wholesale and general access drug stores, and the pharmacy departments in hospitals.

According to the regulations, the participants of the "distribution chain" are obliged to report the medicinal products turnaround data to the Integrated Monitoring System of Medicinal Products Turnaround (in Polish: Zintegrowany System Monitorowania Obrotu Produktami Leczniczymi, or: ZSMOPL), in the area of data indicated in the Art. 72a Clause 2 – wholesalers and general access drug stores, pharmaceutical points and pharmacy departments in hospitals, in the area of data of the Art. 72a Clause 2, point 1 letters a-e and points 2 – 4 – obliged entities.

What is important, according to changes announced by the Ministry of Health in legal regulations, until the June 30^th, 2017, there will be no legal actions taken, which would be to the non-compliance with the Art. 127c of the Act of 6^th September 2001 – Law on Medicinal Products (Journal of Laws of 200, item 271, as amended), and the actions already launched will be discontinued. At the same time, it is planned to extend until the June 30^th, 2017, the period of the currently effective obligation to provide the Minister responsible for Health or the National Pharmaceutical Inspection organs, per their request, the information related respectively to the completed transactions, products on stock, transfers within the stock, or about the fact of a series release.

ZSMOPL Goals

The main goals of the Integrated Monitoring System of Medicinal Products Turnaround is support for the Public Administration Institutions, Main Pharmaceutical Inspectorate and the President of the Office for Registration of Medicinal Products and Biocidal Products, in their task of running the State's Medicinal Products Policy.

Integrated Monitoring System of Medicinal Products Turnaround will allow, among others, to monitor at the retail and wholesale level of the medicinal products Turnaround, and reporting this information to the proper institutions. The basic functionalities of this system will include gathering, processing and providing the data regarding turnaround of medicinal products, including:

Medicinal products admitted for sale on the territory of the Republic of Poland,
Refunded medicinal products and special purposes food products admitted for sale on the territory of the Republic of Poland,
Medicinal products included in targeted and interventional imports.

Data regarding turnaround of the monitored products will be submitted on a daily basis. The whole range of information gathered within the system will allow for analysis of the wholesale and retail turnaround, quantities of the planned deliveries and about shortages of the medicinal products.