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from human cells and tissues can be found at www.basg.gv.at/gesundheitsberufe/gewebesicherheit , www.basg.gv.at/gesundheitsberufe/blutsicherheit und www.basg.gv.at/fuer-unternehmen/bewilligung-und-zertif [...] guideline is not legally binding. Binding information requires a separate request (to ATMP-leitfaden@basg.gv.at ) and can only be provided for specific cases after thorough examination of all information
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
safety officers of hospitals, must immediately report to the Federal Office for Safety in Health Care (BASG) any serious incidents of which they become aware as a result of their professional activities. The [...] there is a suspicion of counterfeiting of a medical device, this must be reported immediately to the BASG. Products involved in incidents must not be destroyed, but must be subjected to a root cause analysis [...] para. 4 MPG 2021 ) In connection with Safety instructions in the field, or notifications from the BASG about existing health hazards from implants, the healthcare facilities or physicians responsible for
Sampling reference substances form (F_L677) Further inquiry note basg.cpaa@basg.gv.at Assessment of Certificates of Suitability (CEP) BASG is involved in the assessment of CEPs („Certificate of Suitability [...] Picture 1 Picture 2 Picture 3 Enqueries: E-mail: nat@basg.gv.at Enqueries (for media): Communications Management, Tel.: 050555/25000 E-mail: presse-basg@basg.gv.at Quality defect Information on how to report [...] questions regarding NCRs please contact am-qualitaetsmangel@basg.gv.at , in case of questions regarding concerned products please contact lcm@basg.gv.at . Risk assessment of nitrosamines in medicinal products
medicines under additional monitoring . Further information Electronic national reporting system of the BASG. Websites of the European Medicines Agency (EMA): Medicines under additional monitoring Good phar