Temporary Disabled. :) please Go back Notices for manufacturers | Therapeutic Goods Administration (TGA) www.fgks.org » Address: [go: up one dir, main page] Include Form Remove Scripts Accept Cookies Show Images Show Referer Rotate13 Base64 Strip Meta Strip Title Session Cookies Contact TGA: info@tga.gov.au | 1800 020 653 | More contact info Translate | Subscribe Therapeutic Goods Administration (TGA) Australian Government Department of Health Main menu Home Safety informationReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Report an issue with packaging or storage of a medicine AEMS guidance for health professionals AEMS guidance for sponsors Help us promote adverse event reporting: promotional resources kit AlertsCurrent year alerts All alerts RecallsAbout Australian recall actions Recall actions database Uniform recall procedure Prescription opioids Medicine shortages Early warning systemMonitoring communications About the Early Warning System Early Warning System: consumer questions and answers Early Warning System: health professional questions and answers Black Triangle SchemeBlack Triangle Scheme: Information for sponsors Safety information & educationMedicines safety Medical devices safety Database of Adverse Event Notifications (DAEN) COVID-19COVID-19 rapid antigen self-tests COVID-19 treatmentsCOVID-19 treatments: Provisional determinations Labels for COVID-19 treatments Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Roche) (Casirivimab and Imdevimab) Labelling Exemption 2021 COVID-19 treatments: Provisional registrations COVID-19 treatments: Treatments undergoing evaluation COVID-19 treatments: Advertising compliance COVID-19 treatments: Information for consumers and health professionals COVID-19 treatments: Information for sponsors (industry) COVID-19 vaccinesCOVID-19 vaccine approval process COVID-19 vaccines undergoing evaluation Provisional registrations COVID-19 vaccine safety monitoring and reporting News and updates COVID-19 vaccine advertising and import compliance Information for consumers and health professionals Information for sponsors (industry) International collaboration ConsumersReport a problem or side effectReporting adverse events involving medicines, vaccines or medical devices Travelling with medicines and medical devicesLeaving Australia Entering Australia Helpful links for travellers Buying medicines and medical devices onlineCounterfeit medicines and devices Can I import it?Personal importation scheme Medicinal cannabis: importation and the traveller's exemption MedicinesHow we regulate medicines Prescription medicines Complementary medicines Over-the-counter (OTC) medicines Vaccines What's on my medicine label? 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For notices about manufacturing medical devices, go to Regulatory decisions and notices (Medical devices and IVDs) 2020 2019 2018 Older, revoked and superseded notices are available in the TGA Internet site archive. 2020 TGA expectations for overseas manufacturing sites hosting remote inspections during the COVID-19 pandemic3 July 2020: Information to assist overseas manufactures who may undergo a remote Good Manufacturing Practice (GMP) inspection during the COVID-19 pandemic GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic3 July 2020: Information about the TGA's approach to Good Manufacturing Practice (GMP) inspections and clearances for overseas manufacturers of medicines and biologicals during the COVID-19 pandemic Transition to new GMP requirements for medicinal products22 June 2020: A notice about the implications of adopting the PIC/S Guide to GMP PE009-14 Exemption to enable timely access to radiopharmaceuticals and RAI6 May 2020: Information on an exemption for radiopharmaceuticals that facilitates interstate supply during COVID-19 Update to Manufacturing Principles for medicines, APIs & sunscreens4 May 2020: The TGA is adopting the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products 2019 Updated GMP licence application e-forms13 March 2019: GMP Licence submission e-forms will be updated on the TBS portal from 15 March 2019 to support the revised fees and charges model 2018 Changed telephone number for enquiries to Manufacturing Quality Branch26 September 2018: Streamlining of Manufacturing Quality Branch contact numbers Medicine GMP - revised fees and charges effective 1 July 201818 June 2018: Changes to Medicine GMP fees and charges will become effective 1 July 2018 Submissions received: Proposal to change the medicine GMP fees and charges18 May 2018: Outcome of the TGA's public consulation on proposed Medicine GMP fees and charges published Implementation of the PIC/S guide to GMP PE009-132 January 2018: On 1 January 2018 the TGA adopted new manufacturing principles to be observed by manufacturers of medicines and active pharmaceutical ingredients The Therapeutic Goods Administration is part of the Health Products Regulation Group
These notices are for manufacturers of medicines, biologicals and blood, blood components and HPCs.
For notices about manufacturing medical devices, go to Regulatory decisions and notices (Medical devices and IVDs)
2020 2019 2018
Older, revoked and superseded notices are available in the TGA Internet site archive.
The Therapeutic Goods Administration is part of the Health Products Regulation Group