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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)
Scientific advice in clinical trials
Parliamentary work on Poland’s draft Act on Clinical Trials of Medicinal Products for Human Use is coming to an end. According to the bill, entities involved in clinical trials and introduction of new drugs will be able to receive scientific advice from the president of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. This will enable better preparation of tests and trials and consequently faster registration of safe and effective drugs.
Scientific advice in clinical trials
PFAS: Pervasive forever chemicals
PFAS is a collective name for some 5,000 chemical compounds widely used in industry and everyday items. They have a harmful effect on the environment and human health. Recently, they have been the subject of intense research by the European Chemicals Agency and the US Environmental Protection Agency. This is reflected in the growing number of regulations restricting their use. However, awareness of the harmfulness of these compounds seems to remain low, as evidenced by the small number of court cases in this area.
PFAS: Pervasive forever chemicals
Judicial revolution allows online alcohol sales
The judgment of the Supreme Administrative Court of 8 September 2022 has broken a relatively uniform line of decisions banning online alcohol sales.
Judicial revolution allows online alcohol sales
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
Information or advertising? What pharmacies are allowed to do
In 2012, a restrictive ban on advertising by pharmacies was introduced into Polish law. According to Art. 94a of the Pharmaceutical Law, it is only permissible to provide information on the location and working hours of a pharmacy or a pharmacy outlet. Violation of the ban can draw a heavy fine, up to PLN 50,000. In practice, the advertising ban is strictly enforced by the province pharmaceutical inspectors, which results in numerous administrative fines imposed on businesses.
Information or advertising? What pharmacies are allowed to do