European database , where you will find information on adverse reactions of medical products and active substances (at EU level). Report templates human (only available in German) Formular: Nebenwirkung [...] the relevant information into the EudraVigilance database. The MLM service currently includes 300 active substances and 100 herbals. The results of this research is available for MAHs and member states

Healthcare GmbH Oberndorfer Straße 35/1 5020 Salzburg Inverkehrbringer Arzneimittel, PV-System 482453 ACTIV APOTHEKE Tribuswinkel Mag. pharm. Dr. Claudia Heinrich-Pretterklieber KG Pfarrgasse 11 2512 Tribuswinkel

Referenced at:

• Pharmaceutical companies

Nein 09.09.2024 03.01.2024 15.10.2024 - - 102659255 482453 ACTIV APOTHEKE Tribuswinkel Mag. pharm. Dr. Claudia Heinrich- Pretterklieber KG ACTIV APOTHEKE Tribuswinkel Mag. pharm. Dr. Claudia Heinrich- P [...] 1121 Wien Nein 30.08.2024 03.09.2024 - - - 103484199 482453 ACTIV APOTHEKE Tribuswinkel Mag. pharm. Dr. Claudia Heinrich- Pretterklieber KG ACTIV APOTHEKE Tribuswinkel Mag. pharm. Dr. Claudia Heinrich- P

Referenced at:

• GMP/ GDP

distribution in accordance with Section 10c of the Medicines Act. 13. Are active substances subject to the Arzneiwarenimfuhrgesetz? Active substances are not covered by the Medicinal Products Import Act. The [...] medicinal product have to be notified to the BASG if it is shipped from another Member State? 13. Are active substances subject to the Arzneiwarenimfuhrgesetz? 14. The application of the provisions of the 2010

Up-to-date information from the 16.09.-19.09.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

the activities for each manufacturer (e.g. manufacture of tablets, primary packaging, secondary packaging, batch control testing Names and full addresses of all approved manufacturers of the active substance [...] different from manufacturer of active substance) If not applicable, please state N/A Names and full addresses of all approved CEP holders (if different from manufacturer of active substance) If not applicable [...] MRP/RUP submission date in (the new) CMS(s) (if yes, explain in Appendix 1)? ☐ Yes ☐ No Active Substance Active Substance Master File(s) (ASMF)? ☐ Yes ☐ No Currently approved version*: If applicable, please

Referenced at:

• DCP/MRP/RUP/SRP Slots

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.

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