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according to article 11 para 1.3. Therefore no shipment notification or import application to the BASG is required. For imports in the context of a named patient use ("Heilversuch"), please refer to the
65 (3) of the Austrian Medicines Act via electronic submission in the eService (https://eservices.basg.gv.at/ ). The following key personnel are not subject to notification : - Head of Production: requirements [...] responsible person according to § 9 (4) GSG via electronic submission in the eService (https://eservices.basg.gv.at/ ) are subject to notification in advance or without undue delay in case of unforeseen changes [...] undue delay in case of unforeseen changes via electronic submission in the eService (https://eservices.basg.gv.at/) . e. Licence holder: Pursuant to § 56 (2) of the Austrian Medicines Act (AMG ) as amended
certification documents and the final report are sent to the Federal Office for Safety in Health Care (BASG). The procedure has now been completed ( AVG ). Electronic submission The in the following listed
clinical trials Interventional clinical trials must be approved by both the regulatory authority (BASG) and the ethics committees. The submission documents consist of the following three parts: information
Referrals and PSUSAs will be published on the BASG homepage ( PV-wordings ) When submitting the variation, please state the following in accordance with the BASG letter in the coverletter ( e.g. ' PHV-Issue:
medicinal products) and send it to BASG if an import certificate or a certificate of marketability according to the Medicinal Products Import Act (AWEG) is to be applied for at BASG. Note: If, in the case of [...] notification for the study medication has to be sent to the Federal Office for Safety in Health Care (BASG) in any case. For this purpose, please use the electronic reporting portal to be used since 04.07 [...] Notifications (Electronic Submission Ordinance 2011 - EEVO 2011; published in the Official Gazette of the BASG ), applications and notifications under the AWEG have to be submitted in electronic form since 04
any agreements on content with the BASG. They are therefore not suitable for comparison with inspection results of the BASG and are of no legal significance for the BASG. In the event that hazardous practices [...] practices are identified by the third country authority and reported to the BASG, the BASG is obliged to initiate corresponding activities. [...] implementation of draft laws in our QM landscape. Can the Inspectorate act as a consultant here? No. The BASG offers the inspection of a design qualification to verify plans/projects/changes. The inspection of
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