Australian Regulatory Guidelines Good Manufacturing Practice (GMP) Clearance for Overseas Manufacturers 17th Edition Version 1.0 May 2011 Therapeutic Goods Administration Copyright Commonwealth of Australia 2011 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney Generals Department, National Circuit, Barton ACT 2600 or posted at http:/www.ag.gov.au/cca GMP Clearance for Overseas Manufacturers, 17th Edition Version 1.0, May 2011 Page i About the Therapeutic Goods Administration (TGA) The TGA is a division of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices. TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. To report a problem with a medicine or medical device, please see the information on the TGA website. Therapeutic Goods Administration GMP Clearance for Overseas Manufacturers, 17th Edition Version 1.0, May 2011 Page 3 of 39 Version history Version Description of change Author Effective date V1.0 New Document Office of Manufacturing Quality 12/05/11 Therapeutic Goods Administration GMP Clearance for Overseas Manufacturers, 17th Edition Version 1.0, May 2011 Page 4 of 39 Contents Introduction 6 TGA Contact Details _ 8 Regulatory information _ 8 1. Responsibilities of Australian sponsors of medicines manufactured overseas 9 2. GMP Clearance process 11 Figure 1 - Overview of the GMP clearance process _ 11 2.1. GMP Clearance application requirements _ 12 GMP Clearance _ 12 Renewing a GMP Clearance _ 12 Changes to a GMP Clearance _ 12 Extension of a GMP Clearance _ 13 2.2. Pathways for obtaining GMP Clearance _ 13 GMP Clearances issued under a Mutual Recognition Agreements (MRA) _ 14 GMP Clearances issued through GMP Compliance Verification (CV) _ 14 TGA on-site audit _ 14 2.3. Identify and obtain the required documentation _ 15 Table 1(a) Required assessment type _ 15 Table 1(b) Documentary evidence requirements _ 16 General documentary requirements _ 17 GMP Certificates _ 18 Manufacturers declarations for Active Pharmaceutical Ingredients _ 19 Documents for a TGA on-site audit _ 19 Sharing of documentary evidence between sponsors and manufacturers _ 19 2.4. Submit application and pay fees _ 20 Lodging an application for clearance by MRA and Compliance Verification _ 20 Failure to provide adequate GMP evidence _ 21 Payment of application fees (for MRA and CV) _ 21 Lodging an application for a TGA on-site audit _ 21 Fees for TGA on-site audit _ 21 Schedule of fees _ 21 Therapeutic Goods Administration GMP Clearance for Overseas Manufacturers, 17th Edition Version 1.0, May 2011 Page 5 of 39 2.5. TGA assessment _ 22 Target timeframes _ 22 2.6. Outcomes of TGA assessment _ 22 Clearance approval _ 22 Conditional Clearance _