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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.

This report, based on Baker McKenzie’s many years’ experience with nuclear projects around the world, points to the need to implement comprehensive measures in the economic, legal, social and environmental areas, backed by strong and stable state support. This will not only significantly strengthen Poland’s energy security, but also provide a strong impetus to technological progress, new investments, the development of science, and increasing the competitive advantages of Polish companies.

On 22 March 2023, the European Commission tabled a proposal for a Directive on substantiation and communication of explicit environmental claims.
The proposal aims to harmonize the evaluation and monitoring of voluntary environmental claims – often referred to as “green claims” – towards EU consumers and control the proliferation of public and private environmental labels. Complementing the March 2022 proposal for a Directive on empowering consumers for the green transition as a lex specialis by providing more specific requirements on the substantiation, communication and verification of green claims, it contributes to the fight against “greenwashing”.

Industrial action is on the rise throughout Europe; in this webinar we looked at the differences and similarities in the industrial action process across France, Germany, Italy, Spain, the Netherlands, Poland and the UK, the potential legal remedies in each jurisdiction and the practical steps employers can take to keep the business running.

The implementation of the Polish Hydrogen Strategy, adopted by the Polish government in November 2021, naturally requires a number of legislative actions aimed at the creation of a stable regulatory environment. This should remove barriers to the development of the hydrogen market and encourage a gradual increase in investments in this sector.

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.