Joanna Krakowiak | In Principle

Amendments to the EU’s provisions on medical devices were published in the Official Journal on 9 July 2024. The new rules will begin to apply six months after publication (i.e. from 10 January 2025). In vitro diagnostic devices are gaining extended certificate validity and longer transition periods. The EUDAMED database can be launched in steps, which should speed up the mandatory use of the modules that are now ready. Meanwhile, manufacturers and other participants in the distribution chain have a new obligation to report problems with availability of medical devices.

Food manufacturers are eager to use QR codes on their labels. Now the EU has normalised the use of these codes in the regulations. For now, the new rules apply only to the wine industry, which is pioneering in this area of food labelling. The QR code rules should make it easier for the industry to meet its new obligations to provide wine consumers with ingredients and nutrition information.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.