Romania: Flavoured heated tobacco products soon to become history
Two months from now, the sale of flavoured heated tobacco products will be banned in Romania. Recent legislative changes aimed at aligning the country's laws with those of the European Union extend the prohibition of flavoured tobacco products from cigarettes and roll-your-own tobacco to heated tobacco products. Producers and traders will thus need to review not only their stocks, but also their labelling obligations when placing heated tobacco products on the market.
Major legislative changes in Hungary's pharma and food industry
Significant legal changes occurred in the Hungarian pharmaceutical and food industry in the summer of 2023. According to Government Decree No. 333/2023. (VII. 20.), as of 1 August 2023, the National Public Health Centre (NNK) and the National Institute of Pharmacy and Nutrition (OGYÉI) merged, establishing a new authority, the National Centre for Public Health and Pharmacy (Nemzeti Népegészségügyi és Gyógyszerészeti Központ, NNGYK).
Regulation of nicotine pouches in the Czech Republic
Nicotine pouches are small pouches or pads containing nicotine and no tobacco. They are placed under the lip so that the nicotine is absorbed into the body through the mucous membrane. This alternative to traditional tobacco products, especially cigarettes, has been growing in popularity in recent years.
Slovakia: New regulation promoting sale of healthy food in Slovak schools
As of 15 March 2023, a new regulation on the sale of certain types of foods in schools was introduced by Decree of the Ministry of Health of the Slovak Republic No. 75/2023 Coll., on details of requirements for facilities for children and adolescents (the "Decree"). The aim of the regulation is to provide a nutritionally valuable range of food in school catering establishments, mainly fresh vegetables and fruit.
Bulgaria: Schoenherr advises Queisser Pharma on acquisition of new office space in Sofia
Schoenherr advised Queisser Pharma Bulgaria on the asset deal acquisition of its new office space in Sofia from real estate developer Tremont. This acquisition marks one of the first office space asset deals in Bulgaria since the start of the COVID-19 pandemic.
Inzidenzen, (Intensiv-)Bettenbelegungen, COVID-19-Virus(varianten), eine Durchimpfungsrate von 90 %, nicht zuletzt die Omikron-Variante sind seit Monaten aus dem Wortschatz der medialen Berichterstattung über die omnipräsente und themenbestimmende COVID-19-Pandemie kaum wegzudenken.
The EU Clinical Trial Regulation: big data and … human rights
The new EU Clinical Trial Regulation ("Regulation No 536/2014" or "CTR") was published in May 2014 as Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use. It repeals Directive 2001/20/EC and is applicable to a certain extent as of the end of January 2022.
Austria: Schoenherr advises Cerba HealthCare on acquisition of Lifebrain from Investindustrial
Schoenherr advised French diagnostic centre group Cerba HealthCare on the acquisition of the Lifebrain Group from Investindustrial. Lifebrain owns and operates diagnostic laboratory centres throughout Italy and in Austria. The signing of the transaction took place on 18 July 2021 and closing is subject to regulatory clearances expected in Q4 2021.
Austria: Schoenherr advises BASF on transaction with Novartis/Sandoz at major industrial site in Kundl, Tyrol
Schoenherr advised BASF SE (BASF) on a major investment project at the Kundl/Schaftenau Campus in Tyrol, Austria. On 26 April 2021, BASF entered into an agreement with Sandoz GmbH, a subsidiary of the Novartis Group, which is already operating various biotech production facilities in Kundl and Schaftenau.
Ready for the cladogenesis of traditional healthcare?
It's June 2019 and the key players from the digital, healthcare and pharma industry have gathered at the Health Tech Summit in Lausanne to discuss a future in which preventive medicine will be customised for each patient. The idea is based on three milestones: active life (sports), mental health (healthy lifestyle) and eating habits (food). Poor eating habits and stress especially lead to the early onset of chronic diseases, costing the healthcare system billions of euros.
Pharmaforschung: ICC-Schiedsgericht spricht Schönherr-Mandantin Millionenbetrag zu
Erfolg für AOP Orphan Pharmaceuticals vor einem Frankfurter ICC-Schiedsgericht: Das Wiener Pharmaunternehmen setzte sich mit der Ansicht durch, dass ein Vertrag mit dem taiwanesischen Arzneimittelhersteller Pharmaessentia weiter Bestand hat und bekam in dem Verfahren 143 Millionen Euro zugesprochen, unter anderem für Schadenersatz und Kosten.
Austria: Schoenherr advises listed AddLife on its acquisition of DACH Medical Group
Schoenherr, together with Advokatfirman Delphi, advised AddLife, a Swedish Medtech company listed on the Nasdaq Nordic Exchange, Stockholm, on the acquisition of all shares in the DACH Medical Group Holding AG. The transaction agreement was signed on 1 October 2020.
Bulgaria: healthcare & life sciences in a global pandemic
Healthcare and life sciences have a special status as a type of legal practice. The debate about what this specialisation entails, and to what extent it even qualifies as legal work, is endless. However, as a crisis is also an opportunity, the coronavirus pandemic has defined the areas where law, healthcare and the life sciences overlap.
The Police, Drones, and the Corona Pandemic – Reflections on Austria
The Corona pandemic is putting our world to an unexpected stress test. But despite all difficulties, in only a couple of weeks, people dramatically changed the way they work, shop, seek health care, and interact with each other.
Am 01.04.2020 tritt die Verordnung über die Sicherstellung der Arzneimittelversorgung ("AMVS-VO") in Kraft. COVID-19 war zwar nicht der Grund für die Erlassung der Verordnung, die Auswirkungen der Corona-Pandemie könnten jedoch schnell zum ersten größeren Anwendungsfall der AMVS-VO werden.
Hungarian government settles pharma debts: An opportunity for factoring companies? | Hungary
Hungarian hospitals are facing problems paying for drugs and medical devices. Many suppliers have claims worth millions of euros and are having difficulty enforcing them against either the hospitals or the Hungarian government.
Bulgaria: New Legislation in the Rose Cultivation Sector
Bulgaria is well-known for its roses, more precisely its oilseed roses (маслодайни рози). Oilseed roses are famously used to produce rose oil, which is one of the most expensive oils, commonly referred to as "liquid gold".
Seven out of the 328 pages of the new green/conservative government's programme are dedicated to the health sector. One bullet point on this programme for the next five years is to implement telemedicine treatment in the best possible way. The government further explains that it aims to promote digitalisation in diagnosis, treatment and medical research and thus strengthen Austria as a health hub.
Schoenherr advises Apax Partners on the acquisition of a majority stake in ADCO Group
Schoenherr Czech Republic and Poland acted as a collateral advisor to Apax Partners, the global private equity advisory firm managing Apax Funds ("Apax") on the acquisition of a majority stake in the ADCO Group, the global market leader in the mobile sanitary unit sector.
Growing cannabis in Bulgaria: Legal but still stigmatised
Bulgarian legislation on the legal cultivation of cannabis makes for interesting reading. Some readers might feel that the regulations and definitions are the most hilarious things ever, and this article aims to shed light on why this may be, while running you through some legalities.
The health care sector continues to see competition from traditional and non-traditional industry participants. At the same time, patients want continuously available, affordable and better health care and increasingly view medical treatment like any other (professional) service. Patients therefore are demanding cost-efficiency, high quality, ease of access and 24/7 availability.
Healthcare Update - Mastering New Trends: Teleradiology* - Austria
Technology and innovation are key drivers of advancement in a variety of industries, and certainly in healthcare. The level of patient care can be improved considerably with the right mix of traditional and innovative treatments and solutions. Nevertheless, there are regulatory challenges to overcome.
Non-compliance in the Healthcare Sector - Iceberg ahead! - Austria
If anyone needed a wakeup call as to how critical a functioning compliance system and culture is, look no further than the recent reports in the Austrian media about allegations of fraud launched against a surgeon working at one of Vienna's most renowned public-sector hospitals.
As of tomorrow, the traditional Austrian bakery Aida, which is known for its staff dressed in baby pink, will sell brownies containing CBD. The price will be EUR 4.20 – an inside joke, since "four-twenty" is code for the consumption of cannabis.
European Union: Your Web Doctor will see you now - software as a medical device
Patients nowadays have access to an enormous range of medical knowledge through social media, websites and health apps (in combination with wearables). The latter have become increasingly popular in recent years because of their ability to monitor in real time pulse, blood pressure, blood glucose levels and other parameters.
Austria: Two Years Of Online Sales Of Medicinal Products In Austria
Austrian legislators have been reluctant – if not outright hostile – to permit any kind of online sale of medicinal products within the country. It has been just over two years since Austrian pharmacies were finally granted the right to sell medicinal products to consumers.
On 15 May 2017 the President of Poland executed the Act of 7 April 2017 amending the Pharmaceutical Law (the "Amending Act"), which changes the current regulations of the Act of 6 September 2001 Pharmaceutical Law (Journal of Laws of 2016, items 2142 and 2003) regarding the issuance of permits to operate public pharmacies.
Legislative vacuum filled: Czech Republic introduces comprehensive new national legislation on e-cigarettes
New legislation regulating e-cigarettes in the Czech Republic entered into force on 1 March 2017, introducing specific safety and quality requirements on e-cigarettes in the country for the first time.
In early 2015 the Bulgarian Ministry of Health (“Ministry”) announced its intention to follow the example of Denmark and to propose a tax on “unhealthy foods”. The aim is to limit the consumption of foods which increase the risk of chronic diseases such as obesity, heart disease, diabetes type two etc. The opinion of the National Centre for Public Health (“Opinion”) justified the Ministry’s idea that the high costs associated with widespread chronic diseases legitimise the imposition of fiscal measures. The intended taxes will affect four groups of foods which contribute to the increased risk of chronic diseases.
Bulgaria: Is This Chicken That I Have, Or Is This Fish?*
In 2003 Ms. Simpson, confused by a food label, dropped this line in a TV-show and immediately landed in the "dumb blonde" stereotype. Ten years later, Bulgarian consumers face the same confusion, wondering, "Is this chicken, or is this … water"?
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