life science | In Principle

Go to content
Subscribe to newsletter
In principle newsletter subscription form

life science

Will there be more transactions on the pharmacy market?
There have been few transactions on the pharmacy market in Poland since 25 June 2017, when the amendment to the Pharmaceutical Law popularly known as “Pharmacies for Pharmacists” entered into force. The transactions that did occur carried significant regulatory risk. This situation may change due to a recent interpretation by the Ministry of Health. Will we witness a gradual departure from the restrictive limitations under the 2017 amendment?
Will there be more transactions on the pharmacy market?
No supplementary protection for a new form of an active substance
In a judgment of 21 March 2019 (C-443/17) the CJEU reiterated the need for a precise and concise interpretation of the term “protected product” under Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products. The CJEU stressed that this term only applies to an active ingredient of a medicinal product, and not combination with other substances that do not have an independent therapeutic effect.
No supplementary protection for a new form of an active substance
Food law 2019: GMO-free labelling
“GMO-free” offers a strong and appealing marketing message. The use of this claim is not regulated at the EU level. Individual member states, including Poland, are adopting national criteria that must be met by products for the manufacturer to call them GMO-free. What are these criteria, and what products do they apply to?
Food law 2019: GMO-free labelling
Food law 2019. Double standards in food
The European Parliament has specified areas in which measures are to be taken to prevent unreasonable variation in product quality on the single EU market. Varying quality in this way will be a prohibited market practice. This is the main change planned for 2019, but not the only change.
Food law 2019. Double standards in food
Food Law 2019. Vegan food—what does it really mean?
The controversial judgment of the Court of Justice of the European Union in TofuTown (C-422/16) triggered a long-delayed discussion on the proper labelling of vegetarian and vegan food. This issue, which for a long time has not been a priority for the European Commission, is just becoming one. Will the time of regulatory uncertainty, to the detriment of producers, consumers and regulators, come to an end?
Food Law 2019. Vegan food—what does it really mean?
Can the name of an alcoholic beverage be misleading?
Alongside the trademark, the label of a product must also identify the product itself, so that consumers know what type of product they are being offered. But in the European Union alone, there may be a dozen or more legal definitions of certain alcoholic beverages, such as cider or perry. This means that the qualitative requirements differ across various member states, presenting a huge challenge for producers, particularly when the EU policy agenda has taken up the fight against double standards for foods offered in different parts of the EU.
Can the name of an alcoholic beverage be misleading?
CJEU on transparency of medicine registration data
On 5 February 2018 the CJEU issued long-awaited judgments in three cases in one day concerning release to third parties of medicinal product registration documentation. These rulings confirm the European Medicines Agency’s current data transparency policy. How are conflicting interests weighed regarding release of medicine registration data?
CJEU on transparency of medicine registration data
Medical data—keep or delete?
From 25 May 2018 Polish healthcare institutions will face conflicting rules on how to handle medical documentation under the EU’s General Data Protection Regulation and Polish healthcare laws. The inconsistencies could be eliminated by the new Personal Data Protection Act, but it appears unlikely that work on the new act will end on time. So what should institutions do to limit their regulatory risk?
Medical data—keep or delete?
I know what I'm drinking – Polish version
Consultations have ended on a draft amendment of the Act on Sobriety Education and Countering of Alcoholism as well as the Food Safety and Nutrition Act. They are to raise the awareness of consumers and help them make informed choices, now in relation to alcoholic beverages.
I know what I'm drinking – Polish version
Who must conclude a written contract for supply of agricultural products?
Long-awaited regulations limiting the scope of the duty to conclude written contracts for supply of agricultural products went into force on 22 August 2017. Under the new rules, the requirement for written contracts applies only to supplies of defined groups of agricultural products from farmers operating in Poland.
Who must conclude a written contract for supply of agricultural products?
Pharmacies for pharmacists—but what about patients?
The amendment to the Pharmaceutical Law adopted under the slogan “pharmacies for pharmacists” entered into force on 25 June 2017. What are the strict regulations supposed to protect pharmacists against: a shortage of customers, or excessive expansion of their own business? How will this amendment function, and is there another one ahead under the slogan “pharmacies for patients”?
Pharmacies for pharmacists—but what about patients?
Green light for self-regulation of the drinks industry
In March 2017 the European Commission published a report on labelling of alcoholic beverages. It seems the exemption allowing alcohol producers to avoid placement of information on the ingredients and nutritional value of their drinks is drawing to an end. The beer, wine and spirits industry has 12 months to propose solutions to the Commission reflecting the specific nature of alcoholic beverages but also ensuring effective protection of consumers throughout the European Union.
Green light for self-regulation of the drinks industry