e-Leki

e-LEKI

the e-Leki system is a proprietary solution of KBJ S.A.

Our offer is addressed to the users of the SAP system, obliged, in accordance with the requirements of the Pharmaceutical Law, to submit reports on the sale of drugs.

The e-Leki solution is:

Sending data to ZSMOPL directly from the SAP system,

The sending of each message can be planned independently and in an automated manner but also cyclically

Archiving of all messages sent from the application,

Advanced configuration of the tool, global and broken down into messages,

Monitoring of the solution and the status of sending messages,

Full compliance with the standard SAP authorization system,

Separation of the e-Leki standard software in the namespace / KBJ / and client configurations, which guarantees safe software update,

Reporting functions,

Compliance with the requirements of the Pharmaceutical Law, the e-Leki solution supports all messages required by the Ministry of Health:

Trade and Stock Announcement containing information on trade in medicinal products. The report is built on the basis of material movements, purchase invoices and sales invoices, as well as optionally from data contained in the QM (Quality Management) module,
Shortage Notification Message containing information about products ordered by cooperating entities, which are not in stock at the moment,
Delivery Planning Message containing scheduling agreements, orders, contracts.

Why the e-Leki solution?

The following comprehensive package guarantees you a safe solution to fulfill your obligations regarding reporting information in accordance with the guidelines of the Ministry of Health:

ZSMOPL data reporting

Guarantee of fulfillment of all obligations related to with ZSMOPL data reporting

Support and software update

Guarantee of support and software updates, including changes and new types of messages in the event of their introduction by the Ministry of Health, without additional license fees

Stable XML platform

The e-Leki solution is based on the proven and stable XML Studio platform used for production in over 150 companies

Over 10 years of experience

KBJ specializes in providing customers with software on the SAP platform. Over 10 years of experience has resulted in a number of solutions for approx. 300 thousand. end users in enterprises with a combined total of over one million employees

Quality

Quality guarantee - while delivering e-JPK software in 2016, we simultaneously carried out several dozen implementation projects in over 100 companies. All customers, regardless of the configuration and version of the SAP system, provided the required declarations and reports in accordance with the applicable deadlines

e-Leki Offer

Thanks to the e-Leki system, the obligations resulting from reporting information on the turnover of medicinal products directly to the ZSMOPL system are fulfilled. Our offer includes the following elements:

E-Leki software with a license,
3-year support and software updates,
Technical documentation and end user manuals,
Implementation of the e-Leki solution in your SAP system,

Support in the procedure of gaining access to the ZSMOPL evaluation and production environment,
Training on the e-Leki solution,
Software manufacturer's warranty.

On January 1, 2017, new provisions of the Pharmaceutical Law of September 6, 2001 came into force, imposing additional obligations regarding the provision of information on the trade in medicinal products for responsible entities, entrepreneurs operating a pharmaceutical wholesale store as well as generally available pharmacies, pharmacy points and hospital pharmacy departments.

Pursuant to the regulations, the participants of the "distribution chain" were required to report data on drug turnover to the Integrated Monitoring System for Trade in Medicinal Products (in short: ZSMOPL), in the scope of data indicated in Art. 72a paragraph. 2 - wholesalers and generally accessible pharmacies, pharmacy outlets and hospital pharmacy departments, and in the scope of data specified in Art. 72a paragraph. 2 point 1 lit. a-e and points 2 - 4 - responsible entities.

It is important that, in accordance with the changes to the regulations announced by the Ministry of Health, no proceedings will be initiated until June 30, 2017 in connection with the violation of Art. 127c of the Act of 6 September 2001 - Pharmaceutical Law (Journal of Laws of 2008, item 271, as amended), and possibly the initiated proceedings will be discontinued. At the same time, it is planned to extend the current obligation to provide the minister competent for health or the bodies of the State Pharmaceutical Inspection, at their request, with information on transactions, inventory levels, warehouse transfers or the fact of batch release, respectively, to the minister competent for health or the authorities of the State Pharmaceutical Inspection.

The main task of the Integrated Monitoring System for Trade in Medicinal Products is to support public administration bodies, the Main Pharmaceutical Inspector and the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in conducting the state drug policy.

The Integrated Monitoring System for Trade in Medicinal Products will enable, inter alia, monitoring at retail and wholesale level of medicines and reporting this information to the competent authorities. The basic functionalities of this system include collecting, processing and sharing data on trading in monitored products, including:

Medicinal products admitted to trading in the territory of the Republic of Poland,
Reimbursed medical devices and foods for special nutritional uses admitted to trading in the territory of the Republic of Poland,
Medicinal products from direct and intervention import.

Data on trading in monitored products will be provided on a daily basis. The scope of information collected in the system will allow for analyzes of wholesale and retail trade, the volume of planned deliveries and shortages of medicinal products.