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Proposed changes to Product Information (PI)
This consultation closed on 26 July 2010.
The TGA is proposing that only one product information document should be approved and published for each prescription medicine product.
As there is now open access to product information details on the ARTG, there is increased potential for confusion arising in the minds of healthcare professionals and consumers through the availability of a 'published' product information document which differs from the "registered" product information document in relation to the same product.
More information is available below:
Proposed changes to Product Information (PI)
The Australian Regulatory Guidelines for Prescription Medicines (ARGPM) currently include a provision that
"A sponsor must have a PI for all registered medicines, however, not all registered presentations may be marketed. A sponsor may choose to have and maintain two PI documents, one for all registered product presentations or non-marketed product presentations and another for marketed product presentations. Each document requires review and the documents must be consistent regarding all information except presentation and information specific for the omitted presentations." (ARGPM paragraph 220.127.116.11 Marketed and unmarketed product presentations).
The intention of this policy was to permit a sponsor to include on the Australian Register of Therapeutic Goods (ARTG) a pack size or container size which was not at the time to be distributed in Australia. As a result, the product information document approved for the purpose of inclusion of the entry of the medicine onto the ARTG ("registered" product information) included mention of that pack size or container size, but the distributed ("published" product information) document did not. Under the Therapeutic Goods Act 1989 different pack or container sizes do not create separate and distinct therapeutic goods that would normally require a separate ARTG entry. Other differences, such as different tablet strengths or different indications, do create separate and distinct therapeutic goods.
As there is now open access to product information details on the ARTG, there is increased potential for confusion arising in the minds of healthcare professionals and consumers through the availability of a "published" product information document which differs from the "registered" product information document in relation to the same product.
As a matter of public health policy, the TGA takes the view that the "registered" product information document and the "published" product information document for a product must be the same - in other words, only one product information document should be approved and published.
A notice of a variation to the wording of para 18.104.22.168 of the ARGPM will be posted on the TGA website to reflect this policy.
- Use of 2 product information documents where pack/container size not marketed
In future where a sponsor chooses not to distribute in Australia a pack size or container size for a registered product, the TGA will permit the single product information document to include, in the Presentations and Storage Conditions section only, an asterisk against a registered pack or container size, together with the following statement:
* not currently distributed in Australia
Alternatively, a standard statement "Not all strengths/dose forms/pack/container sizes (delete as appropriate) are being distributed in Australia" could be included.
If a time arrives when the sponsor wishes to distribute the product in the additional registered pack or container size in Australia, the sponsor could apply to the TGA requesting a variation to the information included in the Register under s.9D(3) of the Therapeutic Goods Act on the basis that it is:
- not a Safety Related Notification (these are covered by s.9D(2) of the Act); or
- not a variation that indicates any reduction in the quality, safety or efficacy of the product.
As a change to product information where no evaluation is required, a fee of $1,320 would be payable (item 2A(a), Part 2 of Schedule 9 of the Regulations).
The same approach will be adopted where a sponsor has particular strengths or concentrations registered in relation to a product but chooses not to distribute the product in those strengths or concentrations in Australia.
It is intended that the TGA's delegates will apply these amended requirements to all approval decisions from a to be agreed point of time in the future. Sponsors of applications under evaluation at that time that may be affected will be able to contact the Head of the relevant Clinical Evaluation Unit to discuss their specific submission.
- Use of 2 product information documents in other cases
The TGA acknowledges that there are currently some prescription products currently being supplied in Australia that have a "published" product information document and a separate "registered" product information document where the differences relate to matters other than non-distribution in Australia of a pack size or container size, or a product strength or product concentration. This might be, for instance because there are less extensive or fewer indications in the product proposed to be marketed in Australia and therefore less extensive or fewer indications in the "published" document. As indicated above, the TGA will not in future approve more than one product information document in relation to a registered product.
Some sponsors have avoided the need to seek two separate product information documents as follows.
- Two submissions are lodged with the TGA for the registration of two separate (but identical) products but with separate trade names and different indications (ie one has few indications than the other). The two submissions are taken to be one submission for the purpose of determining evaluation fees (items 1(2) and (3), Part 1 of Schedule 9 of the Therapeutic Goods Regulations 1990). Separate product information documents are approved on registration of each product reflecting the different names and indications. An application can be made for an exemption from payment of the annual registration fee for the product that is not marketed (i.e. the product with all indications) on the basis of "low value turnover" (regulation 45AAC of the Therapeutic Goods Regulations 1990).
- If a time arrives when the sponsor wishes to market in Australia the product with the more extensive or additional registered indications, the sponsor can apply to the TGA requesting:
- cancellation of the registration of the currently marketed product from the ARTG; and
- the transfer of the trade name of the now cancelled product to the product that it is now intended to market (with all the indications included in its approved product information document.
- This application is handled as an application to change the name of a product. As a type of minor variation, a fee of $4,290 is payable (item 4(g), Part 2 of Schedule 9 of the Regulations). The time allowed for the TGA to process such an application is 45 working days. Handling of the application can be expedited if the application is limited to the requests for cancellation and name change.
Once this process has been completed, the sponsor is able to market a product with the initially marketed trade name but with the expanded list of indications. Sponsors should be aware that the Consumer Medicines Information must be consistent with the registered product information document.
The sponsor is expected, especially in instances where information is included with the distributed product, to carefully address such issues as run-out of "old" stock and to time name changes accordingly.
More than one product information document will not be approved for the same product with different indications where the application is lodged after an agreed future date. Sponsors of applications currently under evaluation seeking to have two product information documents approved in relation to different indications should contact me to discuss what options might be pursued.
This policy change will be supported by the removal of the "not for publication" option from Product Information lodgement facility on the TGA website. The change will also have a follow on effect of making available to the public all Product Information documents within 2 weeks of market authorisation. This removes the ability for a sponsor to withhold a Product Information document from the public, once the ARTG entries have been created, until a later date.
Attachment A: Revised changes proposed to sections 22.214.171.124 and 126.96.36.199 of the ARGPM
188.8.131.52 Marketed and unmarketed product presentations
A sponsor cannot have more than one PI for each registered medicine; however, each PI may refer to multiple register entries (different strengths, dose forms) and/or multiple presentations (pack size, container size).
Where a sponsor has registered a strength, dose form, pack size or container size of a product which it chooses not to distribute in Australia, the TGA will permit the single PI document to include, in the Presentations and Storage Conditionssection of the PI only, an asterisk against a registered strength, dose form, pack or container size, together with the following statement:
* not currently distributed in Australia
Alternatively, a standard statement, "Not all strengths/dose forms/pack/container sizes (delete as appropriate) are being distributed in Australia", could be included.
184.108.40.206 Editorial changes to the product information
An application for a minor editorial change must:
- not be a SRN (Section 9D(2) of the Act); and
- not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used (Section 9D(3) of the Act).
Review is limited to checking that the proposed editorial change meets the criteria for a minor editorial change.
These minor editorial changes to the PI cannot be made by the sponsor without prior approval. They include:
- changes to headings to ensure compliance with Appendix 8 to this document;
- relocation of text, without text changes to comply with Appendix 8 to this document;
- deletion or addition of an asterisk against a registered strength, dose form, pack or container size to indicate whether or not the presentation is distributed in Australia;
- deletion of text that relates solely to deleted indications. However, sponsors do not have the right to delete accompanying texts, for example, precautions.
An application for a minor editorial change must include:
- a copy of the approved PI on which the changes have been clearly identified and a clean copy of the amended PI;
- an assurance that no other changes have been made to the PI document;
- a justification as to why the changes have been made;
- the relevant fee.
Any subsequent printed version of the PI must show the date of the TGA approval and the date of the minor editorial change as Date of amendment.