All set with Swedish SmPCs for the Finnish market?
As of 9 February 2022, all human and veterinary medicinal products with a marketing authorisation and traditional herbal medicinal products with a registration on the market in Finland must have a summary of product characteristics also in Swedish. Our dedicated Product Information Team consisting of translators and regulatory affairs experts has vast experience in national product […]
Long transition period concerning health claims in trade marks and brand names is ending - are you prepared?
When a trade mark or a brand name of a food implies that the food has particular characteristics related to health or nutrition, the Regulation (EC) No 1924/2006 on nutrition and health claims must be considered in its use. In fact, such trade marks or brand names may only be used when accompanied by a […]
Changes to maximum amounts of vitamins and minerals in food supplements and fortified foods expected in the EU – Sweden preparing national regulation
At the moment, the EU legislation does not specify any upper limits or maximum amounts for vitamins and minerals in food supplements and fortified foods. This means that food business operators themselves are responsible for ensuring that the amounts of vitamins and minerals in their food products are at a safe level. Some EU countries have set […]
Publication of webinar speakers – Medfiles’ 2021 pharmaceutical webinar on Thursday 25th of March
Join Medfiles’ free live webinar on Thursday 25th of March from 1 pm to 2:30 pm (UTC+2)! Our second webinar of the 2021 webinar series is aimed at EU pharma business operators. Medfiles will organise a webinar series this spring for those working in pharmaceutical, medical device, IVD or food and feed sectors. The webinars will be organised […]
Introduction of ‘nutrient profiles’ is currently being planned in the EU – the initiative is now open for feedback
Have you already given your input on the new European Commission initiative proposing changes to food labelling? The European Commission is planning the introduction of ‘nutrient profiles’. The change could mean that a nutrient profile in front of the pack would become a mandatory requirement for food products, indicating the total fat content as well […]