In vitro diagnostic medical devices (IVD) are tests performed on human samples (such as blood, urine or tissues) to provide information on a person’s health. Until 2017 IVDs were regulated by the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD). In May 2017 the new Regulation (EU) 2017/746 on in vitro diagnostic medical [...]
About Emilie-Marie VieubleThis author has not yet filled in any details.
So far Emilie-Marie Vieuble has created 167 blog entries.
In view of the current pandemic, conducting a clinical trial on cough & cold seems challenging. If you are a manufacturer for a product with immunomodulatory activity and wish to generate data substantiating this, a&r’s Clinical Research team can be a partner for you even in these trying times. We have the ideas and [...]
Are you a manufacturer of infant formula? Do you plan to innovate your portfolio with new ingredients? If the logistics for obtaining a marketing authorization for your new ingredients are what’s holding you back, then a&r may be just the partner for you. Our Clinical Research team has extensive experience in clinical trials for [...]
Calls are open for consultation on the new EFSA guidance on nano-particles and the nutrient definition. EFSA's Scientific Committee has launched an open consultation on its draft EFSA Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles. This document sets out information requirements [...]
For nearly 15 years, trademarks and brand names that have existed in the EU before January 1, 2005 were granted a temporary exemption to the Nutrition and Health Claims Regulation (EC) No 1924/2006 (Article 27(2) NHCR). This means that names that imply a health claim, e.g. “Vital”, “Healthy” etc, were permitted to be used [...]
We dedicate this July issue to clinical research on infant nutrition and immune health, to the ending of the NHCR exemption for trademarks and brand names, and to EFSA’s open consultation on its technical draft for nanoparticles. Also, join us for our next webinar on the upcoming IVDR and prepare [...]
We dedicate this June issue to the on-going regulatory hurdles around CBD and the Commission evaluation regarding health claims on botanicals. […]
Recent regulatory news related to CBD worldwide. EU On June 8, 2020, two CBD novel food applications for synthetic Cannabidiol passed EFSA’s validity check. We look forward to more news. However, according to Vitafoods Insights and CBD-Intel, the progress on novel food authorizations for CBD-extracts (non-synthetic cannabinoids) will be paused until EU regulators decide [...]
Plants and their preparations are widely available on the EU market as foods or as herbal medicines, and their classification as “food” or medicine is of the responsibility of Member States. Thus, a plant substance classified as a “food” in one Member State, can be classified as “medicine” in another Member State. The European [...]
25 June 2020 – analyze & realize GmbH (a&r), the leading consulting and clinical research organization with specific focus on natural consumer health care products, is pleased to announce the appointment of Dr. Volker Schehlmann as new Managing Director. This appointment by the a&r shareholders is another step towards further strengthening the company with specific expertise [...]