Regulatory update on red yeast rice monacolins in food supplements. The European Commission is evaluating a possible total ban, with transitional periods of 6 or 12 months. Analysis of timelines, regulatory implications, EFSA’s role and impact on nutraceutical companies. Red yeast rice monacolins are once again at the center of the European regulatory debate. In…
Crucial Judgment from the EU Court of Justice on Health Claims for Botanical Substances A recent and significant ruling by the Court of Justice of the European Union (EU) is redefining the regulatory landscape for the use of health claims related to botanical substances in food products and food supplements. In particular, the decision in…
Gruppo FarmaImpresa at the Top of European Quality: Maximum Safety for Gynecologic Well-Being The EU Regulation 2017/745 (MDR) is Europe’s most stringent framework for manufacturing and marketing medical devices. It raises the bar on safety, quality, and traceability, introducing far stricter requirements than previous directives. For Gruppo FarmaImpresa, obtaining MDR certification for the Class IIb…
Navigating the Future of Medical Devices: A Deep Dive into the European Commission’s MDR Revision and Industry Proposals for a More Efficient and Innovative Landscape The European Commission has officially announced the launch of the Medical Device Regulation (MDR) revision, a welcome development for the industry. This initiative, communicated by European Commissioner for Health, Olivér…
MDR Transition Extended Beyond 2024: Ongoing Market Access for Our Nasal Kits The MDR (Medical Device Regulation), in force since May 2017 and fully applicable from May 2021, governs medical devices across Europe. Thanks to the extended transition timelines, devices compliant with the MDD Directive can remain on the market until December 31, 2027, for…
Ensured Continuity: Our Osteoarticular Line Is Ready for the MDR Future The Medical Device Regulation (MDR), in force since May 2017 and fully applicable as of May 2021, governs medical devices in Europe. Thanks to deadline extensions, devices compliant with the previous MDD Directive may continue to be marketed until December 31, 2027 for Class…
A crucial EU ruling (Case C-589/23) redefines the distinction between medical devices and medicinal products, clarifying when a substance—like D-mannose—exerts a pharmacological action under Directive 2001/83/EC The boundary between “medicinal product” and “medical device” is often subject to divergent interpretations in European markets, especially for so-called borderline products that do not clearly fall under one…
A crucial update for the nutraceutical sector The food supplements sector is constantly evolving and requires continuous updates from manufacturers, distributors, and healthcare professionals. One of the main sources of regulatory change in Europe is the application of Article 8 of Directive 2002/46/EC, which allows the European Commission to take preventive action on ingredients considered…
Snail-based oral medical device for cough relief – already approved in Morocco Entering new markets is easier with an experienced partner Entering a new market quickly is easier when you rely on someone who has already paved the way. Thanks to our direct experience with the registration of this specific product in Morocco, we can…
The Court of Justice of the European Union has annulled the regulation that banned aloe and other laxative plants In its ruling of November 13, the Court of Justice of the European Union decided to fully annul Regulation (EU) 2021/468, which prohibited the marketing of aloe and preparations containing hydroxyanthracene derivatives (HAD), and also imposed…