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Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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Austrian Medicinal Product Index (all medicinal products regardless of the authorisation date) and BASG-Announcement (recently authorised medicinal products) If the final classification of the prescription
pending, simply notified by sending the information to the appropriate mailbox ( rms@basg.gv.at , basg-cms@basg.gv.at or nat@basg.gv.at ) respectively. There are no costs arising with this notification, being
procedures exist for such products? 5. Will BASG inform me every time a marketing authorisation/registration is about to expire? 6. How do I notify the BASG of the date of actual marketing in Austria? [...] Please note: If no marketing data are available, BASG will assume that the proprietary medicinal product has not been marketed. 6. How do I notify the BASG of the date of actual marketing in Austria? Marketing [...] ion/registration holder will not receive a separate written confirmation from BASG that the request has been granted. BASG reserves the right to verify the accuracy of the information provided by the marketing
the BASG, this provision must be interpreted as meaning that the marketing authorisation holder must be informed at the latest at the same time as the application; from the point of view of the BASG, there [...] or can the tray be labelled with the information required for the primary container? 14. How is the BASG to be informed about the products we display at the EMA? 15. In case of nat. approved preparations [...] authorisation,applicant shall be informed of application.Can the appl. be filed earlier? 16. Does the BASG also require a notification to this effect for centrally authorised products? 17. Is a translation
earlier than 30 days after finalisation of the procedure. If this is done before being contacted by BASG (Federal Office for Safety in Health Care) this lies within the responsibility of the MAH. 2. Which
Where to report You can report your suspicion to us via mail or email. Mail address: enforcement@basg.gv.at Postal address: Federal Office for Safety in Health Care, Institut Überwachung - Enforcement [...] is possible without danger. A list of all Austrian distance selling pharmacies can be found on the BASG homepage.
Content Legal foundations for tissue safety The role of the Federal Office for Safety in Health Care (BASG) in the context of tissue safety The role of the European Commission Definition of procurement es [...] European Parliament and of the Council. The role of the Federal Office for Safety in Health Care (BASG) in the context of tissue safety Contact person of the European Commission (Competent authority for [...] changes in the certificate or authorisation of a tissue establishment. Further inquiry note inspektionen@basg.gv.at
Information Shortages Based on reports from pharmaceutical companies, BASG informs about current shortages. Shortages read more Reporting to BASG The Federal Office relies on reports from consumers, health care [...] information from the BASG directed to consumers (patients, their relatives and owners of animals). read more For Health Care Professionals This is the subpage with information from the BASG directed to health [...] subpage with the official announcements and public databases provided by the BASG as well as procedures for reporting to BASG. read more
national product information on condition that the national product information will be submitted to BASG 4 months prior to the planned market launch of the medicinal product at the latest. Conditional a [...] the texts (see market launch). Market launch: The national product information must be submitted to BASG 4 months prior to the planned market launch. Submission of the texts with no open procedures: via [...] information as well. Finally the MAH will receive an approval letter (Genehmigungsschreiben) from BASG referring to the already issued conditional authorisation including the national product information
medical device or in vitro diagnostic medical device. The Federal Office for Safety in Health Care (BASG) performs delimitation or classifications of medical devices or in vitro diagnostic devices based [...] Electronic Submission Regulation 2011, the notification has to be done by email to medizinprodukte@basg.gv.at . The European accredited reporting forms are to be used for reporting. For field safety corrective [...] are met. Please note the current Fee Regulation . To apply for a derogation, contact medizinprodukte@basg.gv.at in advance by e-mail.