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in a new marketing authorisation number or be integrated into the existing marketing authorisation. BASG processes the latter within the scope of the life cycle, which is why the marketing authorisation
Mock-ups AT Guidance document – Mock-ups This guidance document summarizes the legal basics and the BASG requirements with regards to the mock-ups of human and veterinary medicinal products there by providing
manufacturer's recommendations into account. No special calibration intervals are prescribed by the BASG. During inspections, however, the justification for the periodic functional tests and the suitability [...] brought to the attention of the Ethics Committee before they take up their duties. Information to the BASG is only required if contents of the EudraCT notification form are concerned. This notification can
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
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
with the involvement of the Ministry of Health and the Federal Office for Safety in Health Care (BASG). The Supervisory and Control Advisory Board of AMVO exercises the supervisory and control powers [...] medicinal products an email with subject „application for § 3a AMBO 2009“ should be forwarded to cp@basg.gv.at . identifyer sticker | 48 KB 12/02/2019
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
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
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
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