Contact lenses are not cosmetics
The varying definitions of life science products and applicable provisions of EU directives and regulations can confuse even the most experienced judges, as in the case of a recent preliminary ruling by the Court of Justice sought by the regional court in the German city of Krefeld.
Additional information about foods: A benefit for the consumer or a threat to competitors?
Apart from information about food products required by law, food producers may include optional information on labels concerning the characteristics of the product. Typically not much additional information is provided, because after inclusion of the mandatory data there’s not much room left on the label. This makes selection and verification of this additional information particularly important. Well-chosen additional information can help sell the product, but poorly chosen information can generate serious legal problems.
New criterion for evaluating product safety
The Court of Justice of the European Union has held that the probability of a defect can make a product defective.
Upcoming (r)evolution in school shops – what can food producers offer children in Polish schools?
After more than two years of discussions, the Food Safety and Nutrition Amendment Act concerning children’s nutrition at schools was enacted on 28 November 2014. The new law, which comes into force on 1 September 2015, aims to eliminate unhealthy food from school shops and prohibit the promotion of unhealthy foods within educational institutions.
New rules for access to clinical reports
The European Medicines Agency has adopted a policy of proactive publication of reports from clinical trials. The rule of transparency of clinical results is to be implemented starting 1 January 2015, and the first publications should coincide with entry into force of the EU’s new Clinical Trials Regulation, scheduled for 28 May 2016. What will the new rules mean in practice?
The new EU data protection framework and medical research
The EU’s proposed General Data Protection Regulation has raised issues about the impact that new privacy protections may have on how clinical trials are conducted and information about patients is used for research purposes. Sylwia Paszek of Wardyński & Partners discussed concerns about the draft regulation in an interview by Simon Fuller.
An educated consumer is a huge asset for any firm
An interview with Katarzyna Wójcicka, chair of the Expert Council of the Polish Council for Supplements and Nutritional Foods (KRSiO), and Joanna Krakowiak, chair of the Ethics Committee of KRSiO and legal adviser in the Life Science and Regulatory Practice of Wardyński & Partners.
Should the registration documentation for medicines be public?
A dispute over the documentation to the medicine Esbriet shows how much controversy is stirred up by the disclosure of registration documents for medicines to third parties. How to balance the interests of innovative pharmaceutical companies, manufacturers of cheaper generics, and doctors who seek full knowledge of the safety and efficacy of the drugs they prescribe?
Myths and facts about innovations in the foods sector
The dynamic growth in market share of functional foods calls for a critical review of myths that have arisen around R&D projects in the food sector.
No more junk food at schools in Poland?
The Polish parliament is currently discussing draft amendments to the Law on Food Safety and Nutrition which aims to eliminate unhealthy food from school shops and to prohibit all forms of promotion of unhealthy foods within educational institutions.
Market leader: can there be more than one?
In times of fierce market competition, it is becoming increasingly attractive to construct advertising campaigns that contain superlatives, in particular regarding market leadership.
Prof. Jan Lubiński: We won’t go far without innovation
An interview with Prof. Jan Lubiński, geneticist and researcher into the role of microelements in prevention of cancer, founder and CEO of Read-Gene SA, and member of the Council of the National Centre for Research and Development.
