Product Information(PI) and Data Sheets(DS) are legal documents that require approval from the TGA/Medsafe and cannot be changed without approval from these authorities. We work with your team to ensure document control is maintained and that guidelines are met. We will manage any variations or notifications and follow through the process to the final artwork approval of printed material as applicable. Consumer Medicine Information documents, while not “approved” in the same way as PI’s and DS’s, still require the same attention to detail and care in terms of document control and maintenance that PI’s and DS’s require. Regulatory Concepts maintains inhouse regulatory folders on your behalf to ensure that the latest approved version of your documents are always close at hand and instantly available.
Part of the process of reviewing proposed label changes is to also determine the impact of those changes. With our 30+ years of experience we are able to review proposed changes, determine the variation pathway, time and costs and If there is a way to reduce the costs and time we will provide suggested alternatives for your consideration. If both Australian and NZ markets are impacted, we will look at how to streamline the process and coordinate the applications in both countries, thus reducing the overall costs and time.
- Variation Submissions
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Part of the process of reviewing proposed label changes is to also determine the impact of those changes. With our 30+ years of experience we are able to review proposed changes, determine the variation pathway, time and costs and If there is a way to reduce the costs and time we will provide suggested alternatives for your consideration. If both Australian and NZ markets are impacted, we will look at how to streamline the process and coordinate the applications in both countries, thus reducing the overall costs and time.