Life Sciences

New ECJ ruling: indication of intended use & precautions for use of cosmetic products

CJEU, Judgment of 17.12.2020, C-667/19 - Intended use of a cosmetic product and information on special precautions for use: Consumer language and product catalog. The decision is based on the case of an owner of a Polish beauty salon who purchased American cosmetic products from a sales representative, on the packaging of which the intended use did not appear. Instead, there was a symbol depicting a [...]

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 [...]

Pharmacy reservation is in conformity with the constitution - finding of the VfGH

Supreme Constitutional Court from 03.03.2021, V 75-76/2019-15 – Pharmacy reservation is in conformity with the constitution. In the third application to the Constitutional Court by an Austrian drugstore chain to annul the pharmacy proviso on the grounds of interference with freedom of purchase and violation of the principle of equality, the court succeeded in obtaining a substantive decision. However, the application was rejected. As a brief reminder, the content of the first two applications was not processed because [...]