G/TBT/N/AUS/167  
4 March 2024  
(24-2002) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  AUSTRALIA  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
Therapeutic Goods Administration, Department of Health and Aged Care  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Australian WTO TBT Enquiry Point  
Office of Global Trade Negotiations  
Department of Foreign Affairs and Trade  
Canberra ACT 0221 tbt.enquiry@dfat.gov.au  
+61 2 6261 1111  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medicines  
5. Title, number of pages and language(s) of the notified document:  Pharmaceutical 
Inspection Co -operation Scheme (PIC/S) Guide to Good Manufacturing Practice for 
Medicinal Products, 1 February 2022, PE -009- 16; (235  page(s), in English)  
6. Description of content:  The Therapeutic Goods Administration (TGA) administers 
Australia's regulatory framework for the quality, safety, efficacy of therapeutic goods in 
Australia.  
There are provisions under the Therapeutic Goods Act 1989  (the Act) to establish 
Manufacturing Principles that are to be applied in the manufacture of therapeutic goods. 
The Therapeutic Goods (Manufacturing Principles) Determination 2020  (the 
Determination ) is the legislative instrument that specifies the manufacture of therapeutic 
goods must comply with the applicable procedures and requirements in the 
Pharmaceutical Inspection Co -operation Scheme (PIC/s) Guide to GMP.  
As a PIC/S member, Australia is expec ted to adopt and enforce the latest revisions to the 
GMP guide to achieve international harmonisation between member countries. Adoption 
of the PIC/S Guide to GMP as Australia's Manufacturing Principles negates the need for 
Australian -specific standards, f acilitates international trade and supports our international 
reputation.  
The adoption of an internationally harmonised standard minimises regulatory burden for 
companies involved in the manufacture, import and export of medicines, facilitating trade 
and h elping to ensure the availability of medicines to the Australian public.  G/TBT/N/AUS/167  
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable:  The Determination currently specifies that the manufacture of therapeutic 
goods must comply with  the applicable procedures and requirements in the PIC/S Guide 
to GMP (PE009 -15, 1 May 2021) except for its Annexes 4, 5, and 14.  
There is a more recent version of this document, PIC/S Guide to GMP (PE009 - 16, 1 
February 2022) and Australia needs to adopt this version to ensure that the rules 
regulating the manufacture of therapeutic goods in Australia are equivalent to those 
adopted by other international regulatory authorities.  
Failure to adopt version 16 of the PIC/S Guide to GMP (PE -009-16) would lead t o 
inconsistencies between domestic and international manufacturing principles which will 
likely lead to a disadvantage for Australian manufacturers wishing to export to overseas 
markets as well as reputational damage the Australian manufacturing sector and  TGA's 
international standing.  
The TGA is proposing to amend the Determination to adopt version 16 of the PIC/s Guide 
to GMP except for Annexes 4, 5 and 14 as the manufacturing principles and register the 
amended Determination on the Federal Register of Le gislation in June 2024. ; 
Harmonization  
8. Relevant documents:   
https://www.tga.gov.au/resources/publication/publications/pics -guide -gmp-medicinal -
products -version -16 
9. Proposed date of adoption:  3 June 2024  
Proposed date of entry into force:  3 June 2024  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://www.tga.gov.au/resources/publication/publications/pics -guide -gmp-medicinal -
products -version -16