verstöße werden dargestellt und vom Juristen der AGES PharmMed zur Anzeige gebracht. Areas of activity The activities of the Department for Medical Market Surveillance can be divided into three distinct areas [...] this process has been successful. I am proud to be able to present to you the first review of our activities - the annual report for the year 2006. Marcus Müllner, Director AGES PharmMed Der Bereich PharmMed [...] objectivity and impar- tiality in all of the services we provide. From an administrative viewpoint, our activities are carried out according to private industry principles, guaranteeing that all our tasks are

Referenced at:

• Annual Reports and Facts Folder

Press Release - Kick Off Meeting CHESSMEN, Rome, 10.02.2023

Referenced at:

• European Network

Questions & Answers - Kick Off Meeting CHESSMEN, Rome, 10.02.2023

Referenced at:

• European Network

c Advice) V.3.a bei im EWR neuen Wirkstoffen (new active substances), sowie Biosimilars 10.865 V.3.b bei im EWR bekannten Wirkstoffen (existing active substances) 6.791 V.4 Labortechnische Analysen für

Referenced at:

• Official announcements

among other things, must be taken into account individually with regard to the sensitivity of the active substance/test preparation. A blanket reference to stability data is not a substitute for temper

How are we supposed to validate our process if we use a third-party data system for GMP-relevant activities? GMP relevance of a system and validation obligation is given if a manufacturing step is supported [...] during validation. What are the responsibilities for carrying out a risk analysis? How should this activity be defined? The risk analysis should always be performed by the user. When transferring a risk analysis

ASMF 1. How to submit an ASMF? 2. What are the requirements for an Active Substance Master File (ASMF), which is part of an application for marketing authorisation, variation or renewal? 3. How should [...] documents see Guideline: electronic Release Regulation EEVO (L_Z45) . 2. What are the requirements for an Active Substance Master File (ASMF), which is part of an application for marketing authorisation, variation

contains a detailed description of the circumstances under which a medicine should not be taken. All active ingredients and other excipients of a medicinal product are listed in the package leaflet in section

n may be repeated five times (i.e. a total of six times), unless stated otherwise. However, some active substances (e.g. antibiotics or diazepam) are prohibited from being dispensed repeatedly, so that

consequences. A delayed absorption of the active substance (resorption) or a change in the mechanism of action may occur. For the most parts, delayed absorption affects active substances that are mainly absorbed [...] functioning of the auto-injector (with or without spring activation), the angle at which the device is placed on the skin, the force used to activate the device, and whether sufficient attention is paid to [...] tissue, the way the auto-injector works (with or without spring activation), the angle of insertion, and the force required to activate the device. Due to the uncertainty of the release of adrenaline,