457 - We have been asked to update a patient information booklet for people who have been prescribed the drug. The drug has two indications. Patients may have both conditions, but it's most likely that they have been prescribed the drug for only one of the conditions. Both indications are for adults only and both indications are described in the same Part 3 and use the same patient information booklet. Our drug is coming out with an adolescent indication for only one of the indications. We want to update the patient information booklet to include the adolescent indication. I think it should be fine to add the adolescent indication to the existing approved booklet as long as the adolescent info is in the same Part 3 from which the patient information booklet was developed. Are there any other considerations for putting the adolescent info in a separate booklet? There is not much new content to Part 3 except the age change. Thanks!
Jennifer Carroll last edited by
I believe you mean “Are there any other considerations for putting the adolescent info in the same booklet? ” You’ve emphasized that there is a single part III in the TMA. The fact that there is a single Part III discussing the both conditions and the adolescent population in the context of one of those conditions is important to your argument that inclusion in the piece would be acceptable. The main additional point which jumps out to me is the need to be consistent with the context in which the adolescent content is presented in Part III. Keep in mind that post-approval changes (such as the one you are proposing) require that the piece be submitted to the PAAB for review such that we can review the issue in its complete context. For additional general guidance relating to patient information, please refer to the following guidance document: http://www.paab.ca/resources/pdfs/code-revision/External_Branded_Patient_Information_Guidance_Doc_July_16_2015.pdf