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eu or georg.neuwirther@ages.at respectively nat@basg.gv.at for national applications, rms@basg.gv.at for applications where AT acts as RMS and basg-cms@basg.gv.at for applications where AT acts as CMS. CESP [...] neuwirther@ages.at or our functional e-mail addresses (nat@basg.gv.at for national applications, rms@basg.gv.at for applications with AT=RMS and basg-cms@basg.gv.at for applications with AT=CMS). [...] specific CESP submissions, please contact cesp@basg.gv.at . Further information on CESP can be found at the HMA . eCTD/VNees When switching to the eCTD format , the BASG recommends that at least Module 3 be submitted
ion A.2 – has to be submitted in the UPD after the new name has been reviewed and accepted by the BASG according to Commission Implementing Regulation (EU) 2021/17. This variation can be submitted at any
the company and the associated tasks. On the part of the Federal Office for Safety in Health Care (BASG)/AGES Medical Market Inspectorate, there is no question that each establishment, in accordance with [...] or that a recall was initiated by the wholesaler. In all other cases, from the point of view of the BASG, this is a non-permitted delivery to the wholesaler. If the goods were accepted by the wholesaler
Safety in Health Care (BASG) According to the Austrian Ordinance on Good Laboratory Practice, Federal Law Gazette II 450/2006, the Federal Office for Safety in Health Care (BASG) is a monitoring authority [...] inspection is carried out by inspectors of the BASG. A GLP certificate issued by a member state of the MAD on the basis of an inspection is not recognized by the BASG, if the inspected test facility is located [...] Austrian Medicines and Medical Devices Agency is executing the GLP Monitoring Program on behalf of BASG and can be reached by e-mail at glp@ages.at or by telephone +43 (0) 50555-36403. Test facilities that
an NCR (Non-Compliance Report) is issued officially and published in the Union database and on the BASG homepage. An inspection according to § 67 AMG has taken place in my company. Can GMDP certificates
warehouses, laboratories) must be applied for in advance to the BASG. Alterations to rooms must be applied for in advance to the BASG if they result in changes in the flow of materials, personnel or influence [...] / manufacture of medicinal products, restricted to office operation) must be applied for with the BASG immediately upon moving into the new business premises or taking over the new business location in [...] sterile processes, an application for a change in accordance with § 65 AMG must be submitted to the BASG in each case. In all cases, the respective change must be mapped in the company's internal quality