8.3). Additional standardised requirements are considered for many core processes: for testing activities of the OMCL: ISO 17025 | Quality Management Documents of the OMCL-network for inspections: ISO [...] e (ISO 9001) | 857 KB 27/09/2022 Accreditation in accordance with ISO 17025 New The laboratory activities of the Official Medicines Control Laboratory (OMCL) of the Austrian Federal Office for Safety in

guidelines for quality assurance of production processes and environments in the production of drugs, active ingredients and medical devices. Reference: EMA GMP For blood establishments and establishments [...] arranged alphabetically according to applicants or sites and shows whether a procedure is being actively processed or whether (re)action is required by our customers (clock stop); the respective order [...] in EudraGMDP related to veterinary medicinal products: Wholesale Distribution Authorization (WDA). Active Pharmaceutical Ingredients Registration (API-Reg) The most important change is the integration of

26 May 2021 and it repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices. The In Vitro Diagnostic Devices Regulation applies since 26 May 2022

the co-financing of costs related to JAP activities supports member states’ participation in the JAP. The co-financing of costs related to training activities supports initial and continuous training of

should have implemented the revised template in the course of the next text-relevant regulatory activity (type II variation, type IB variation, renewal, or line extension) until 01-July-2014. In case Austria

98/79/EC on in vitro diagnostic medical devices - legacy devices & old devices Directive 90/385/EEC on active implantable medical devices - legacy devices & old devices Regulation (EU) 2019/1020 on market s [...] of HIV tests for Self-testing Regulation (EU) No 722/2012 concerning Requirements with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin

product. Information on the investigational device may also be written in English. For accompanying activities during the storage, handling and disposal of GMOs, the requirements of the Systems Ordinance 2002

on the CMDh website . Active Substance Master File Worksharing. In January 2024, the CMDh approved an update to the document " The worksharing procedure for the assessment of Active Substance Master File [...] topics. NEWSTICKER 30.06.2024 RECENT COMMITTEE NEWS Medicinal products containing estragole as an active substance or excipient. The CMDh reminds marketing authorisation holders/registration holders of [...] medicinal products ((T)HMPs) containing plants or their preparations containing estragole either as an active substance or as an excipient to check whether their medicinal products comply with the guidance published

a so-called "specification". In this specification it is determined whether or to what extent the active ingredient content may be reduced so that the indicated efficacy is still fully guaranteed. Quality [...] added depending on the dosage form. For example, in the case of tablets, the time during which the active substance is released must be defined, or in the case of parenteral administration - such as infusion [...] storage conditions (e.g. for vaccines and insulin), this can lead to a loss of quality. For example, active ingredients in solutions can precipitate due to cold, and the consistency of ointments can change

patches Proper disposal of transdermal patches is particularly important as large amounts of the active ingredient may still be present in the patch after use. It may have serious consequences up to and [...] of patches if they chew on them, respiratory arrest may occur. Even transdermal patches with other active ingredients such as nicotine or hormones can cause serious side effects. To protect others and the