The first deregulation project in the field of pharmaceutical law submitted to the Sejm
Author: prepared by JKB • Source: Rynek Zdrowia • Published: May 15, 2025 07:00
The first deregulation project in the field of pharmaceutical law at the next stage. It was submitted to the Sejm. We are talking about the draft amendment to the Pharmaceutical Law Act adopted last week by the government.
- A deregulation project in the field of pharmaceutical law was submitted to the Sejm
- As a result, pharmaceutical companies will not have to report to ZSMOPL information on the planned place of delivery of medicinal products intended for sale in the territory of Poland.
- The draft act will enter into force after 14 days from the date of announcement.
The government's draft bill amending the Pharmaceutical Law Act has been submitted to the Sejm. The draft implements the government's deregulation activities.
As we read in the Regulatory Impact Assessment, currently the marketing authorisation holder is obliged to submit information to the Integrated System for Monitoring Trade in Medicinal Products (ZSMOPL) on the planned place of delivery of medicinal products intended for sale in the territory of the Republic of Poland.
However, this is a difficult requirement to implement, because it is often impossible to predict at the reporting stage which wholesaler the delivery of medicinal products will be directed to. At the same time, this is an obligation that is irrelevant from the point of view of monitoring the availability of medicinal products, and also involves duplicating the collected data - it was stated in the OSR.
It was also explained that based on the data collected in ZSMOPL from daily reporting by pharmaceutical wholesalers, it is possible to determine the actual destinations of deliveries, which is sufficient from the point of view of monitoring the market for these products.
It is proposed to amend art. 36z sec. 2 item 4 of the Act of 6 September 2001 - Pharmaceutical Law, which will result in the abolition of the obligation for the responsible entity to indicate to ZSMOPL information on the planned place of delivery of medicinal products intended for sale in the territory of the Republic of Poland - we read.
According to the applicant, excluding the obligation to report to ZSMOPL regarding the planned place of delivery of medicinal products means removing an excessive obligation for the responsible entity.
The proposed act will enter into force after 14 days from the date of announcement.
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