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:
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?
According to the Law on Medicinal Products, the e-Leki solution supports all messages required by the Ministry of Health:
As of January 1st, 2017, there came into effect new regulations of the Act of 6th 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 30th, 2017, there will be no legal actions taken, which would be to the non-compliance with the Art. 127c of the Act of 6th 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 30th, 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.
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:
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.