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Consultation: International harmonisation of ingredient names
This consultation closed on 10 July 2013.
Invitation to comment
The TGA sought comments from interested parties on proposed changes to approximately 472 ingredient names, and an update to the guidance document TGA Approved terminology for medicines as part of the International Harmonisation of Ingredient Names project.
Update, 28 March 2014
The TGA is considering all submissions received as part of this consultation. A Regulation Impact Statement (RIS) is being developed based on the issues raised during consultation.
The TGA will publish consultation submissions once the RIS is finalised and a decision on harmonisation has been made. Please note that due to the delay in preparing a RIS, the implementation timeframes proposed in the consultation paper (from June 2014) will be deferred and new implementation timeframes will be announced as part of the final harmonisation decision.
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International Harmonisation of Ingredient Names - Consultation paper
- Consultation document: International Harmonisation of Ingredient Names (IHIN) (pdf,1.29Mb)
- Consultation document: International Harmonisation of Ingredient Names (IHIN) (Microsoft Word,2.08Mb)
Draft guidance document: update to TGA Approved terminology for medicines
- Draft TGA Approved terminology for medicines document (pdf,923kb)
- Draft TGA Approved terminology for medicines document (Microsoft Word,1.87Mb)
Documents released for consultation on Wednesday, 15 May 2013.
Interested parties respond by close of business Wednesday, 10 July 2013.
Outcomes will be released following consideration of submissions. (see 'What will happen').
About the consultation
The TGA maintains a list of approved names for medicines ingredients in the form of the TGA Ingredients database. The World Health Organization's International Non-proprietary Name (INN) terminology has been adopted for new medicines ingredients as standard policy wherever possible from 2002 onwards. However, several hundred ingredients added to the ARTG prior to this time have names inconsistent with INN terminology, and require harmonisation.
The proposal put forward in this consultation is to harmonise the names of these ingredients contained within medicines, not the names of the medicines themselves. The vast majority of the proposed ingredient name changes are minor, consisting of a single letter change (e.g. amoxycillin to amoxicillin; oestrogen to estrogen; cholecalciferol to colecalciferol).
The proposed changes may affect sponsors of the following products:
- prescription medicines
- over the counter medicines (including sunscreens)
- complementary medicines (both registered and listed)
- Export Only medicines
Consumers who use products that contain these ingredients, and healthcare professionals who prescribe and dispense them will also be affected.
Feedback received from these different stakeholder groups as part of this consultation will be used to determine an appropriate strategy to implement the changes in a way that presents the least possible inconvenience to stakeholders.
TGA approved terminology for medicines
The TGA has considered feedback from industry and other stakeholders that was received during a previous consultation exercise in preparing an update to the TGA Approved Terminology for Medicines. This consultation was conducted in 2006 on a draft document titled 'Draft guidelines and Policies on Australian New Zealand Therapeutic Products Authority (ANZTPA) Determination of Ingredient Names for Medicines'. Any information from this draft document about current TGA naming policy has been incorporated into the TGA Approved Terminology for Medicines, so that sponsors will have access to a single document describing TGA naming policy and procedures in detail.
The TGA is seeking comment on the updated guidance as part of this consultation.
What will happen
Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA's Internet site.
At the close of the consultation period, the TGA will collate and analyse submissions on matters that are within the scope of this consultation.
The TGA will make use feedback received as part of this consultation to develop an appropriate implementation strategy for the changes proposed. The outcomes of this will be published on the TGA website.
Recommendations made by the TGA following consideration of submissions from interested parties will be published on the TGA website as outcomes.
All submissions will be placed on the TGA website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.
For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.
In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.
Any questions relating to submissions should be directed to the project manager for the International Harmonisation of Ingredient Names by email to firstname.lastname@example.org.