1 July 2023 saw the last provisions of the Act of 7 April 2022 on Medical Devices enter into force. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products launched two new online platforms: a list of distributors and a list of users of medical devices. Moreover, since 1 July also an obligation of manufacturers, authorized representatives and importers of custom-made devices to register their activities in Poland before placing such device on the market also came in force.

Since late 2020 a reimbursement fast-track program for the most innovative oncology and rare disease treatments (defined as highly innovative medicinal technologies (HIMT)). For example, the first ever HIMT has become reimbursed for this new procedure in less than two years since its authorization. We also observe an increasing number of rare disease therapies being reimbursed in a standard procedure and the Minister of Health has recently reported progress in the implementation of the Plan for Rare Disease for 2021-2023.

On 30 June 2021, the largest amendment to the Act of 12 May 2011 on Reimbursement of Medicinal Products, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices (“Reimbursement Law”) was published for public consultations until the end of August (“Draft”). The Draft is intended to enter into force within three months of its publication; however, it is difficult to predict how long the legislation process will last.

On 30 April 2021, the draft of a regulation for completely new clinical trials of medicinal products for human use, which implements Regulation 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repeals Directive 2001/20/EC, was published for public consultation.

On behalf of Budapest, Prague and Warsaw offices, we have great pleasure to share with you the latest edition of our CEE Pharma Newsletter, which covers recent legal developments in the pharmaceutical and medical device sectors across the Czech Republic, Hungary, Poland and Slovakia.