Comparative batch data Comparative batch data means a comparison of data between the pre-variation product and the proposed post-variation product. Unless otherwise specified in conditions, these data must compare at least the last three batches that were manufactured under existing conditions (using retention samples, if necessary) and the first batch made under the proposed new conditions, before the first batch is released. The second and third batches manufactured under the new conditions should be reviewed as soon as they become available, and the TGA should be promptly informed of any differences. Where multiple strength (three or more) products are involved and the various strengths are either direct scales (that is, the quantity of all excipients increases proportionally with the quantity of active ingredient) or have closely similar formulations, comparative data may be generated for the lowest and highest strengths only. A Changes to an entry that involve consequential changes to pharmaceutical aspects of the product information Changes to the product information under s. 9D(3) Most quality-related changes to the product information (PI) are approved as consequential changes made at the same time as approval of a request under s. 9D(3) (that is, any of the types of changes listed in this part of the document). There is no need to make a separate self-assessable request to change the PI in these cases. The of changes in this section are requests for quality-related changes to the PI where the only proposed change being requested under s. 9D(3) is a change to the PI. This section covers all quality-related changes to the ARTG entry resulting in changes to the PI that are not described in . Required information A description of the proposed changes to the PI. Details of changes to the PI, as outlined in of this document. Relevant technical data to support the proposed change(s).
Comparative batch data Comparative batch data means a comparison of data between the pre-variation product and the proposed post-variation product. Unless otherwise specified in conditions, these data must compare at least the last three batches that were manufactured under existing conditions (using retention samples, if necessary) and the first batch made under the proposed new conditions, before the first batch is released. The second and third batches manufactured under the new conditions should be reviewed as soon as they become available, and the TGA should be promptly informed of any differences. Where multiple strength (three or more) products are involved and the various strengths are either direct scales (that is, the quantity of all excipients increases proportionally with the quantity of active ingredient) or have closely similar formulations, comparative data may be generated for the lowest and highest strengths only. A Changes to an entry that involve consequential changes to pharmaceutical aspects of the product information Changes to the product information under s. 9D(3) Most quality-related changes to the product information (PI) are approved as consequential changes made at the same time as approval of a request under s. 9D(3) (that is, any of the types of changes listed in this part of the document). There is no need to make a separate self-assessable request to change the PI in these cases. The of changes in this section are requests for quality-related changes to the PI where the only proposed change being requested under s. 9D(3) is a change to the PI. This section covers all quality-related changes to the ARTG entry resulting in changes to the PI that are not described in . Required information A description of the proposed changes to the PI. Details of changes to the PI, as outlined in of this document. Relevant technical data to support the proposed change(s).