all official EU/EEA languages. Active Substance Master File worksharing. After completing the revision of the document ‘ The worksharing procedure for the assessment of Active Substance Master File (ASMF) [...] 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 [...] template is published on the CMDh website under ‘ CMD Working Parties/Working Groups > Working Group on Active Substance Master File Procedures ’. Environmental Risk Assessment (ERA) in MRPs/RUPs. The CMDh agreed

safety and efficacy of a vaccine are reviewed based on preclinical and clinical data. The official activities form a very complex safety net at all levels in the life cycle of a drug or vaccine: clinical trials

use medications with antibiotic active ingredients for the treatment of animals. Do I have to take this into account when registering? No. Medications with antibiotic active ingredients used by veterinarians [...] you begin your activities as a coordinator. Can I become a coordinator without at the same time being a recognised registration office? No. The determination that you may become active as a coordinator [...] dose mean? The maintenance dose is the amount of a drug/active substance (dose) that must be administered to achieve the desired effect. The drug/active substance does not necessarily have to be administered

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