We first wrote about the planned amendments to the Pharmaceutical Law and certain other acts (the so-called Verticalisation Act) in September 2022, when the principles for the amendments were announced in the list of legislative work of the Council of Ministers. On 3 November, the text of the bill was made available on the website of the Government Legislation Centre (Rządowe Centrum Legislacji, RCL). The bill is currently at the public consultation stage.
The planned changes concern the organisation of the State Pharmaceutical Inspectorate, the competences of the bodies performing its tasks, and the financing of the supervision of the pharmaceutical market. This financing has been the subject of lively discussion in the pharmaceutical sector for a number of weeks - all due to the proposal to introduce an annual fee for entities supervised by the Inspectorate, which hold certain licences and register entries. Read more about this in our November update.