Important information from the Federal Office for Safety in Health Care about the known risk of diabetic ketoacidosis (DKA) in cats with diabetes mellitus associated with the use of Senvelgo 15 mg/ml oral solution for cats (velagliflozin).

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 [...] Certificate (ISO 9001) | 857 KB 27/09/2022 Accreditation in accordance with ISO 17025 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

Up-to-date information from the 22.07.-25.07.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

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

Up-to-date information from the 24.06.-27.06.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Eur. Working Party Monoclonal Antibodies MAB Dr. Dieter Pullirsch AGES Mitglied Active Pharmaceutical Ingredient Active Pharmaceutical Ingredient API DI Thomas Lang AGES Mitglied Certification EDQM Ad [...] https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/active-substance-master-file-working-group https://www.ema.europa.eu/en/committees/working-parties-othe

Referenced at:

• European Network

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