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EFSA rejects probiotic claim

The European Safety Authority (EFSA) has concluded that there is “insufficient” evidence to claim a probiotic can help boost iron absorption.

more » 28.07.2016

EU Court: Health Claims Regulation applies to B2B communication

On July 14, 2016, the European Court of Justice (ECJ) ruled that the Nutrition and Health Claims Regulation (NHCR) is applicable to “commercial communications” intended for health care professionals having the goal of indirectly reaching consumers.

more » 22.07.2016

ECJ ruling on labeling of fruit tea

By judgement June 4, 2014, the European Court of Justice (ECJ) ruled the following: the labeling of a product might be suited to mislead the purchaser by indicating or displaying a certain ingredient that is actually not included in the product, if the latter is only made evident by the list of ingredients (ECJ, dec. of June 4, 2014, C195/14).

more » 26.06.2015

Guidance for importers of medicinal products: New Annex 21 GMP

The EU Regulatory System designates importers of medicinal products as manufacturers and subjects them to the holding of a manufacturing authorization (MIA). The EU-GMP requirements applicable to importers of medicinal products are traditionally oriented to activities performed at “true” manufacturing sites. Consequently, in past several issues were subject to discussions by regulators in order to agree a harmonized approach across the EU. The GMP/GDP inspectors working party therefore intends to give further guidance for an EU-wide harmonized approach.

more » 23.06.2015