Legal aspects

On July 12, 2015, the amendment to the Pharmaceutical Law Act, commonly called the “anti-export act", was entered into force to stop the export of reimbursable medicines and to ensure availability of deficit medicines on the Polish market. Under this amendment, on January 1, 2017, new regulations came into force imposing additional obligations related to the provision of information on the trade in medicinal products. According to them, entrepreneurs are obliged to report data on the trade in medicines to the Integrated System for the Monitoring of Trade in Medicinal Products (ZSMOPL), in the field of data indicated in art. 72a sec. 2 – wholesale warehouses and retail pharmacies, limited service pharmacies and hospital pharmacy departments and in the field of data from art. 72a sec. 2 pt. 1 letters a-e and pt. 2-4 – responsible entities.

What is ZSMOPL?

ZSMOPL is an ICT system that is designed to enable daily reporting of transactions, stock levels, and deficiencies in access to monitored products through electronic means of communication. The main task of the system is to support the public administration bodies, including the minister in charge of healthcare, the Chief Pharmaceutical Inspector and the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in pursuing the national pharmaceutical policy.

What and who is subject to monitoring?

The Act sets out three assortment groups to be monitored:

  1. Medicinal products – substances or mixtures of substances presented as having the properties for the prevention or treatment of diseases in humans or animals, or administered for the purpose of diagnosis or for the restoration, improvement or modification of physiological functions of the organism through the pharmacological, immunological or metabolic action.
  2. Foodstuffs intended for particular nutritional uses – substances with a special composition and/or method of preparation, which distinguishes them from commonly occurring and consumed foodstuffs. According to the information on their packaging, they are marketed to meet special nutritional needs.
  3. Medical devices – tools, instruments, apparatus, software, materials or other articles intended by their manufacturer for use for diagnostic or therapeutic purposes in humans to:
  • diagnose, prevent, monitor, treat, or alleviate the disease,
  • compensate for the effects of injury or impairment,
  • examine, replace or modify an anatomical structure or a physiological process,
  • control birth.

The daily reporting of data to ZSMOLP will be the obligation of: pharmacies (both retail as well as company and hospital pharmacies), limited service pharmacies, pharmacy departments in healthcare institutions and healthcare entities.

Healthcare entities

Healthcare entities are considered to be:

  • entrepreneurs within the meaning of the provisions of the Act in all forms provided for the performance of business activity,
  • independent public health care institutions,
  • public institutions, including state-owned, founded and supervised by the Minister of National Defense, the minister in charge of internal affairs, the Minister of Justice or the head of the Internal Security Agency (ABW), having in their organizational structure an outpatient clinic with a sick room or a primary care physician,
  • research institutes,
  • foundations and associations whose statutory purpose is to carry out health care tasks and whose statutes permit medical activities,
  • churches, church legal persons or religious associations – in so far as they carry out medical activities,
  • enterprises within the meaning of the Freedom of Economic Activity Act of 2 July 2004 (Dz. U. of 2007 No. 155, item 1095 and No. 180, item 1280) or entities operating in a Member State of the European Union or a Member State of the European Free Trade Association (EFTA) – parties to the agreement on the European Economic Area, which apply for or have obtained a marketing authorization for a medicinal product.

A responsible entity submits to ZSMOPL the data on:

  • any release of a batch of the medicinal product included in the list, together with the information on the batch number, validity date and size,
  • any sale of a medicinal product to an entrepreneur operating a pharmaceutical wholesale warehouse, to a hospital pharmacy or a hospital pharmacy department, a hospital or other enterprise of a healthcare entity,
  • stock levels of medicinal products,
  • planned deliveries of medicinal products intended for sale in the Republic of Poland, with the specification of the number of unit packages and and the place of delivery.

SNP integration of SAP and ZSMOPL and SNP integration of SAP and ZSMOPL TRANSFER package

In order to enable companies to adapt SAP on time and as quickly as possible, and taking into account the specified due date, a special team of industry-specific and logistics consultants as well as integration specialists has been working at SNP Poland since autumn 2016. The result of its work is the

SNP integration of SAP and ZSMOPL and SNP integration of SAP and ZSMOPL TRANSFER package enriched and expanded on a regular basis, based on the information from the Ministry of Health, specifying the requirements regarding the content and structure of messages.

The ZSMOPL team was made up of professionals with long experience in projects for the pharmaceutical industry, process consultants in the logistics area, as well as integration technology specialists. In the second half of April, we presented our solution in a webinar; we are currently working on additional features.

SNP Poland offers and develops a package of ready-made features for adapting the SAP system to enable the data transfer to ZSMOPL

SNP integration of SAP and ZSMOPL and SNP integration of SAP and ZSMOPL TRANSFER package enables you to generate and store in the SAP system the data required by law and used to prepare messages. Furthermore, it allows its automatic transfer to the ZSMOPL central data repository. Customers who use the solution will be able to generate information that is relevant due to the required inclusion of data in ZSMOPL messages based on goods movements and purchase and sales invoice documents that will be recorded in the SAP system and prepared on a daily basis (e.g. turnover and level messages). The SNP integration of SAP and ZSMOPL and SNP integration of SAP and ZSMOPL TRANSFER product will enable the SAP system to send the required data to ZSMOPL in the form of XML files in accordance with the requirements of the Ministry of Health for the Integrated System for the Monitoring of Trade in Medicinal Products.

Elements of the SNP integration of SAP and ZSMOPL package:

  • a set of necessary dictionary data complementing the basic data required in individual messages,
  • a set of necessary operations/dictionaries identifying business events (including those in the SAP MM module) and organizational structures relevant to the reporting entity,
  • a mechanism of collecting transactions registered (relevant for ZSMOPL) in the SAP system in dedicated tables, for purposes of individual ZSMOPL messages, along with verification of the completeness of their data in terms of compliance with the requirements of the Ministry of Health,
  • preparation, creation and verification of XML messages (a message about turnover and stock levels, a message about shortages and a message about delivery planning),

Elements of the SNP integration of SAP and ZSMOPL TRANSFER package:

  • e-transfer of messages to the central system of the Ministry of Health,
  • support of a certificate,
  • receipt and handling of any errors occurring after the transfer of individual XML messages.