News

Am 23. April 2024 hat die EMA (Europäische Arzneimittel-Agentur) eine Liste von Empfehlungen zur Stärkung der Lieferketten von Arzneimitteln veröffentlicht, welche in der Unionsliste der kritischen Arzneimittel aufgeführt sind. Diese Maßnahmen zielen darauf ab, die Verfügbarkeit von und Versorgung mit kritischen Arzneimitteln zu gewährleisten, deren Lieferkette als gefährdet eingestuft wurde.

The "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety.

According to Chapter 6 of the EU GDP Guidelines, all complaints, returns, suspected falsified medicinal products and recalls must be recorded and handled carefully according to written procedures. In this article, you will find a checklist to verify the minimum implementation.

The wholesale distribution of medicinal products requires a Wholesale Distribution Authorisation (WDA). But where actually to find reliable information on whether a particular company is in possession of such an authorisation or GDP certificate? Depending on the location of the company in question, certain databases are available for searching.