Ments

📣 Sme veľmi hrdí na nášho kolegu, Martin Koša , ktorý popri svojom náročnom pracovnom vyťažení stíha aj takéto aktivity, ako podieľať sa na prvom-svojho-druhu komentári k zákonu o bankách, do ktorého prispel významnou mierou 📒 Naša práca nie je len o klientskych zadaniach 📄 ale aj o vzdelávaní či zlepšovaní povedomia verejnosti najmä o oblastiach, na ktoré sa zameriavame 🥁 Martin, ako vedúci nášho #bankingfinance tímu týmto ukazuje nielen pro klientsky prístup Ments ale aj erudovanosť a odbornosť našich právnikov 👨🎓 Tešíme sa na ďalšie (nielen) Martinove autorské počiny. ------------------------------------------ 📣 We are very proud of our colleague, Martin Koša, who, in addition to his demanding workload, also manages such activities as participating at the first-of-his-kind commentary to the Act on Banks, to which he made a significant contribution 📒 Our work is not only about client assignments 📄 but also about educating or improving public awareness, particularly in the areas we focus on 🥁 Martin, as the head of our #bankingfinance team, demonstrates not only the pro-client approach of Ments firm but also the erudition and professionalism of our lawyers 👨🎓 We are looking forward to (not only) Martin's next authorial endeavours.

🚀 Discover the Future - MedTech Law! 🚀   Calling all 3rd and 4th-year students from Právnická fakulta Univerzity Komenského v Bratislave! Get ready to enroll in an exciting new course – MedTech Legal Clinic!    Additional Details: 🌟 Only in the Summer Semester 🌟Pre-Registration Now Open: Secure your spot today!   Join us and be part of the future in Healthcare Law. #ments #mentsattorneys #MedTechLaw #PraFUK #InnovationInLaw #HealthcareSector

🔬 Ments Life Sciences Market Report 2Q/2024 is here! 🔬 Wondering what has happened and what's on the horizon in the Life Sciences sector in Slovakia? The Ments Life Sciences team has you covered! We've prepared a comprehensive summary of new challenges, amendments, laws, and upcoming legislation in our Life Sciences Market Report for 2Q/2024. 📈 Stay ahead of the curve with the latest insights and developments in this rapidly evolving field. Interested in getting our market report and staying updated? Contact Lukas Michalik or Klaudia P. – they will be more than happy to share the full Life Sciences Market Report with you. #ments #mentsattorneys #LifeSciences #marketreport

🌟 Building Community, One Brushstroke at a Time! 🌟 Our team participated in a volunteer event aimed at revitalizing the community space in a nursing home. Together, we worked to renovate the gazebo, give the terraces a fresh coat of paint 🎨🖌️, and most importantly had a blast in the process! A heartfelt thank you to the organizers and all the volunteers who contributed their time and effort. A huge thanks goes also to the volunteers from Nadácia Volkswagen Slovakia who lured us to participate. Your passion and dedication made this event a success! 🙌❤️ Ments is looking forward for next years! #ments #mentsattorneys #VolunteerWork #TeamBuilding #LawyersGivingBack

💊 Strengthening Supply Chains for Critical Medicinal Products in the EU 💊 The European Medicines Agency (EMA) published a list of recommendations focused on bolstering supply chains for critical medicinal products within the European Union. 📦🔗 EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) is responsible for proposing measures to address vulnerabilities in the supply chain and strengthen the security of supply for these critical medicines. The recommendations of MSSG will be considered on a case-by-case basis, while these (among others) might be the recommendation to: 📈 Increasing manufacturing capacity 🌍 Diversifying suppliers in the supply chain 📊 Monitoring supply and demand 🛡️ Maintaining safety stocks 🤝 Implementing joint procurement mechanisms 📜 Imposing additional regulatory obligations 💼 Providing regulatory support 💡 Offering incentives for investment Collaboration with the Medicine Shortages Single Point of Contact Working Party (SPOC WP) ensures expert input from national competent authorities. Recommendations, once adopted, are documented and published for transparency, with commercially confidential information redacted. Marketing Authorization Holders shall be informed through the Industry Single Point of Contact (i-SPOC) within a week. #ments #mentsattorneys #UnionList #MedicineShortage #RegulatoryAffairs

🚨 Pharma Update Alert 🚨 The European Parliament officially adopted the European Health Data Space Regulation, a game-changer for healthcare across Europe. 📌 This regulation is designed to enhance access to personal health data, fostering better interoperability of healthcare systems and ultimately improving patient outcomes. 🏥 With quicker access to vital information from patients' health records, doctors will be empowered to provide more efficient and effective care. 📌 The legislation is poised to propel the development of new medicines and medical devices by harnessing data in a safe and secure manner. 📊 The utilization of anonymized or pseudonymized data holds tremendous potential, particularly in the realm of rare disease research, but it's crucial to prioritize robust data protection measures for such sensitive information. 🔒 📌 It's essential to recognize that the realization of these benefits hinges on sufficient funding for implementing changes to data management systems across countries. While we await final approval from the Council for this regulation to become law, no surprises are expected. The only question is whether Slovakia will be ready once the implementation of EHDS will take place. Stay tuned for more updates from Ments! 📢 #ments #mentsattorneys #EURegulation #HealthcareInnovation #RegulatoryChanges #Innovation

🎉 News for the Pharmaceutical Industry in Slovakia! 🎉 After 13 years since the adoption of Decree No. 422/2022 Coll. on pharmacoeconomic analysis of medicinal products, the Ministry of Health has unveiled a fresh methodological guide for the preparation and evaluation of such analyses. 📘💊 This updated guide supersedes the previous version and incorporates the latest regulations introduced by the significant legislative amendment of August 2022. 💼✨ In addition to offering clear procedures for reviewers, the guide includes a user-friendly template tailored for marketing authorization holders. This template serves as a comprehensive roadmap for crafting a pharmacoeconomic analysis of medicinal products. 📝🔍 Moreover, the guide enhances clarity on various aspects, such as defining comparators for assessed medicines and outlining procedures for specific scenarios, like statistically insignificant benefits or incorporating newer data. 📊🔬 But perhaps the most crucial aspect of the manual lies in its detailed section on the cost-effectiveness of medicines. It elucidates the individual input data crucial for determining the cost-effectiveness of evaluated health technologies, a pivotal criterion for the inclusion of medicines in the List of Categorized Medicines. Excited to delve into this valuable resource? You can access the Methodological Guide and the marketing authorization holder template directly on the Ministry of Health's website. https://lnkd.in/dGnNGCES #ments #mentsattorneys #HTA #PharmaIndustry #Healthcareinnovation

🔍 What's Next for EU Pharma Reform? 🌱 The EU Pharma Reform recently achieved significant milestones with the approval of the new Directive and Regulation by the Environment, Public Health, and Food Safety Committee (ENVI). To enhance the appeal of the EU research landscape and market, several key proposals have been put forth: 📌 Extending baseline regulatory data protection to 7.5 years. 📌 Implementing a market protection period of 2 years, with an additional year for securing approval for significant new indications. 📌 Offering orphan market exclusivity for 9 years, extendable by 2 years to address high unmet medical needs. 📌 Introducing a requirement for companies to submit a Pricing and Reimbursement (P&R) application to Member States upon request. Recently, Members of the European Parliament (MEPs) endorsed revisions to the Commission's proposals, supporting: 📌 Amendments to Regulatory Data Protection (RDP), orphan market exclusivity, and Antimicrobial Resistance (AMR) regulations. 📌 The potential expansion of the EU Access to Medicines Notification System to include broader pricing aspects within 5 years. 📌 Encouragement of comparative clinical trials. 📌 Possible authorization for the cross-border exchange of Advanced Therapy Medicinal Products (ATMPs) prepared under hospital exemption in cases of medical necessity. What's on the horizon for pharma reform? Join the conversation. 🚀 Our Life Sciences colleagues Lukas Michalik and Klaudia P. are actively working on following and helping to shape the local policy #ments #mentsattorneys #EUpharma #HealthcareReform #RegulatoryChanges #Innovation Ments

🇪🇺 Did you know that the European Commission has taken action against the Slovak Republic? 🇪🇺 The case revolves around the violation of Directive 2011/7/EU, aimed at tackling late payments in commercial transactions. Slovak Republic has continuously failed to ensure that public entities in the healthcare sector pay their commercial debts within a maximum period of 60 calendar days. 📅 Currently, the case is pending, and we eagerly await the outcome, hoping for resolution soon. In the meantime, we at Ments are working to assist creditors in reaching agreements with the relevant authorities. 💼 Our belief is that the sky-high debts in the Slovak Healthcare System must be addressed through substantial and systemic changes. 🏥 Our life sciences team has been helping AmCham Slovakia Health Care Committee (medical device manufacturers, health insurance representatives, and MAHs) initiate negotiations with the Ministry of Health and Ministry of Finance representatives in a relatively short timeframe. 🤝 Hopefully this will lead to conceptual changes in the healthcare. We are looking forward to follow-up meetings to delve deeper into these proposals. 💡 In the meantime, we eagerly await the decision in the case, which could have a critical impact on the Slovak Republic. It serves as a stark reminder from the European Commission, urging the Slovak Republic to comply with its obligations under European legislation. 🇸🇰✉️ #ments #mentsattorneys #healthcare #SlovakRepublic