All legal aspects surrounding the regulatory reforms in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75.
1. Are there proposals for reform or significant change to the healthcare system?
Proposed legislation on medical devices
At the beginning of 2020, a new act on medical devices was published on the website of the Polish Government Legislation Centre. The new act was to replace the one that was passed in 2010 and its main purpose is to adapt Polish regulations to the European legal order, including the Regulation on
Medical Devices and In Vitro Medical Devices, which will be applicable since May 2021. The proposed legislation complemented the above-mentioned European regulations and contained specific solutions, including the creation of a register of entities and medical devices at the national level and a catalogue of legal sanctions. It also regulated in detail advertising of medical
devices. Under the proposed legislation, the registration of producers and their authorised representatives were supposed to be centralised and would take place through the EUDAMED system. Importantly, under the legislation it would not be necessary to re-register products already on the market. However the proposed legislation has been changed a few times since then, so the final wording is not known yet.
2. When are they likely to come into force?
Probably within the next one or two years, but this has not been decided yet.