Joanna Krakowiak | In Principle

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Joanna Krakowiak

Administrative permits and corporate transformations: How to ensure business continuity?
For companies participating in a reorganisation to continue pursuing their owners’ objectives, permits, licences or other administrative decisions necessary for operation must be secured. Proper preparation for this process requires not only knowledge of the regulations under which the administrative decisions are issued, but also the agencies’ procedural practice.
Administrative permits and corporate transformations: How to ensure business continuity?
The EU pharmaceutical package: Can access to drugs be reconciled with innovation?
Work on the EU’s pharmaceutical package is just gaining momentum, but it is already clear how highly controversial the project is. The dispute turns around the protection of drug registration data. This protection helps compensate for the huge financial investment in developing new drugs, but on the other hand delays the registration of cheaper counterparts. The reform would change the duration of this protection and require pharma companies to meet additional conditions.
The EU pharmaceutical package: Can access to drugs be reconciled with innovation?
Sale of energy drinks to minors will be banned
On 28 August 2023, an amendment to the Public Health Act was published, including an important change impacting the food industry. After lengthy debate, it was decided to impose an absolute ban on the sale of energy drinks to minors. Ultimately, proposed advertising restrictions were dropped, but new labelling requirements for beverages containing caffeine or taurine remain. Starting 1 January 2024, the new regulation will force manufacturers and vendors to adjust their internal procedures for marketing energy drinks in Poland.
Sale of energy drinks to minors will be banned
Will pharmacy M&A still be possible?
On 17 August 2023 the parliament held its final vote on a bill to tighten the section of the Pharmaceutical Law known as “Pharmacies for Pharmacists.” Now the act will be sent to the President of Poland, who will decide whether to sign it into law. The amendment (known as “Pharmacies for Pharmacists 2.0”) is stirring a lot of controversy. Its entry into force would significantly restrict the possibility to buy and sell pharmacies, and would require the Pharmaceutical Inspectorate to scrutinise franchise agreements. Pharmacy chains are concerned that the new provisions will lead to expropriation.
Will pharmacy M&A still be possible?
Should food producers fear explanatory proceedings? The notification system for initial marketing of dietary supplements and other foodstuffs
For some time, the initial marketing of certain types of foods in Poland has required notification of the Chief Sanitary Inspector. The notification system for dietary supplements and functional foods has been in place in Poland for more than 20 years, and a similar system is in place in most EU member states. The most questions arise from the initiation of explanatory proceedings involving the classification and compliance of the notified product. Further doubts began to arise at the beginning of 2023, when a long-expected bill amending the regulations governing the procedure for reporting and advertising dietary supplements was published.
Should food producers fear explanatory proceedings? The notification system for initial marketing of dietary supplements and other foodstuffs
Advertising of medical devices: Currently only with warnings
On 13 May 2023, a new regulation with detailed requirements for advertising of medical devices enters into force. Advertisers of such products, including influencers, must include warnings in advertising messages, similar to those familiar from drug advertisements.
Advertising of medical devices: Currently only with warnings
Extending the validity of medical device certificates (March 2023)
On 20 March 2023, an amendment to the Medical Device Regulation was published in the Official Journal of the European Union, extending the validity of certificates for medical devices issued under the earlier regulations. The amendment was adopted as a matter of urgency and went into effect immediately (on the date of publication). The extension is intended to prevent shortages of medical devices on the market.
Extending the validity of medical device certificates (March 2023)
News from Poland – Business & Law, Episode 23: Challenges to food supply chains due to the war in Ukraine – how to avoid regulatory traps
Joanna Krakowiak, attorney-at-law, member of the Council of the European Food Law Association, of counsel at Wardyński & Partners coordinating the work of the Life Sciences & Healthcare practice, explains how the war in Ukraine is forcing regulators to make changes to food law.
News from Poland – Business & Law, Episode 23: Challenges to food supply chains due to the war in Ukraine – how to avoid regulatory traps
Advertising of medical devices and collaboration with influencers
Significant changes are coming for medical device advertising. The rules will be much stricter than before, but still more lenient than drug advertising regulations. For the first time, the new Medical Devices Act regulates influencer advertising. It is already clear that sponsored content will be deemed to be advertising and thus must meet specific requirements under the Medical Devices Act. Companies have until the end of the year to sort out their relationships with influencers.
Advertising of medical devices and collaboration with influencers
Listing of entities for Polish and EU sanctions
At the EU and national levels, severe economic sanctions are in place against many entities, mainly Russian. After entry into force of the Sanctions Act (the Act on Special Solutions for Countering Support of Aggression Against Ukraine and Protecting National Security of 13 April 2022), first published on 26 April 2022, the Polish sanctions list maintained by the Minister of the Interior and Administration took on particular significance. The purpose of its creation is clear: to counter support for Russia’s aggression against Ukraine. Nevertheless, the criteria for inclusion in the list are not clear-cut, and the procedure for issuing a listing decision greatly limits the right to defend against wrongful inclusion, as Polish entities can easily be included in the list.
Listing of entities for Polish and EU sanctions
Sanctions for violating sanctions
Until now, the obligation to comply with the EU economic sanctions regime has arisen directly from the EU regulations, in particular Regulation 833/2014 and Regulation 765/2006 containing restrictive measures against Russian and Belarusian entities, but violation of bans has not been subject to fines. This situation should change, as a bill on special solutions to prevent the support of aggression against Ukraine and to protect national security is being taken up in the Polish parliament.
Sanctions for violating sanctions
The impact of EU economic sanctions on business contracts
24 February 2022, the day when Russian troops unlawfully invaded the territory of Ukraine, proved to be the beginning of a test of European solidarity, and of the resilience of the European economy. On a macro level, a huge question has arisen: Can the European economy function without eastern markets? At the micro level, businesses are faced with dilemmas of how to deal with counterparties from that region, particularly in the context of existing long-term contracts at an advanced stage of completion.
The impact of EU economic sanctions on business contracts