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subject to notification : - Head of Production: requirements according to §69 a AMG and §8 AMBO 2009 - Head of Quality Control : requirements according to §70 AMG and § 9 AMBO 2009 The fulfilment of the formal [...] during inspections by the competent authority. c. Establishments with a licence according to the Tissue Safety Act: According to § 9. (1) of the Tissue Safety Act (GSG ), every tissue bank must have a " [...] undue delay in case of unforeseen changes. d. Blood establishments with a licence according to the Blood Safety Act:: According to § 5 (1) of the regulations on the operation and quality system of blood es
2023 should already be done according to the amended dossier). As a result, the new dossier becomes valid on this date and batches may no longer be certified/released according to the old dossier. Switching [...] / released by the QP according to the "old dossier" before the implementation date may be placed on the market after the implementation date; the corresponding deadlines according to AMG §25a AMG must [...] Implementation date The QP must always certify / release a batch according to the dossier valid at the time. In principle, for Type IB and Type II variations (human) or Variations requiring assessment
companies? Process according to Austrian Medicinal Products Act The following procedures are described on the subordinate pages: Inspection of Good Laboratory Practice (GLP) according to the Ordinance on [...] documents. The inspection of a design qualification is charged in accordance with the ordinance of the BASG on the fee schedule in accordance with the GESG . What significance and impact do inspections by [...] Authorisation and certification Process according to Austrian Medicinal Products Act Further procedures for authorisation What powers do inspectors have in the course of a company audit? Our company has
Notifications in Accordance with the Austrian Medicinal Products Import Act 2010; this document is addressed to any member of an organisation submitting applications or notifications in accordance with the Austrian [...] in accordance with Art 116 of the Austrian Trade and Commerce Regulation Act (Gewerbeordnung) are permitted to act as medicinal products wholesalers only if they are licensed to do so in accordance with [...] license in accordance with Art 63 AMG, even if their wholesaler’s license serves the sole purpose of supplying the procured medicinal products to their own pharmacy. Doctors’ dispensaries: In accordance with