NEW: Medical Device Regulation since 26.05.2021

Regulation (EU) 2017/745 - Medical Device Regulation. For more than 4 years, we have been concerned with the new European Medical Device Regulation (Regulation (EU) 2017/745). Now it has finally entered into force on 26.05.2021, this after the start of validity was postponed by another year from 2020 to 2021 due to Corona. The Medical Devices Regulation comprehensively changes the legal area, the Austrian legislator has also [...]

Distribution of free samples of non-prescription drugs to pharmacies

BGH, judgment of 17.12.2020, I Zr 235/16 - Distribution of free samples of non-prescription drugs to pharmacies. CJEU decision on free samples C-786/18 of 11.6.2020 The distribution of free samples of non-prescription medicinal products to pharmacies is in principle permissible according to decision C-786/18 of 11.6.2020. NEW: Decision of the German BGH In the German original proceedings of this ECJ decision, the BGH has now made the second decision, and the matter [...]

Pharmacological effects of a product for the treatment of cystitis and urinary tract infections

Judgement of OLG Köln of 23.12.2020, 6U18/20 - Pharmacological effects of a product for the treatment of cystitis and urinary tract infections. An interesting ruling on the classification and effect of D-mannose. A product for the treatment and prevention of cystitis, whose essential active ingredient D-mannose as a simple sugar binds the adhesin FimH of the Escherichia coli bacterium so that it can no longer adhere to the bladder wall and penetrate human cells, has a pharmacological and [...]

Amendment of the Food Supplements Directive

The Food Supplements Directive (EC) 2002/46 will be amended in three main points by Regulation (EU) 2021/418 of 09.03.2021: The unit for specifying copper is changed from micrograms to milligrams. Nicotinamide riboside chloride can be used as niacin. Magnesium citrate malate can be used as magnesium. VO (EU) 2021/418. The regulation applies with regard to the indication of the unit of copper [...]

Maximum levels for vitamins and minerals in food supplements and fortified foods

The German Federal Institute for Risk Assessment (BfR) has revised its proposals regarding maximum levels for vitamins and minerals in food supplements and fortified foods. Since there are still no binding maximum levels for vitamins and minerals, particularly at the European level, BfR repeatedly comments on health risks from food supplements and provides information on health problems that may be associated [...]