Members are reminded that the end of the transition period for certain ingredient changes is approaching on 28 February 2023.
Some changes relate to pregnancy warnings, or allergen warnings, which are often subject to retail or consumer level recalls if the required statements are not included.
- maximum daily dose change from 200mg to 100 mg (adults);
- maximum daily dose change for children (depending on age group)
- warning statements on labels for products containing > 10 mg pyridoxine per MRDD.
Artemisinin containing herbs
- End of transition period to include a pregnancy warning for certain existing artemisinin containing ingredients.
Mollusc derived ingredients
- Updated allergen warning
These ingredients were subject to changes following the outcomes of the 2021-22 Permissible Ingredients Consultation. Please see CMA's 27 September 2022 tech alert, the TGA Final Decisions Document and the TGA Oct 2022 publication on Vitamin B6 for more information.
Please note: Due to recent changes in the Advertising Code ‘health warnings’, members should also ensure, as a priority, that relevant advertisements (e.g. where an advertisement facilitates directly the purchase or other supply of a medicine; and the medicine is not able to be physically inspected by a consumer before the purchase or other supply) have the required warnings.
TGA Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey closes 18 December 2022
Pease note: Any sponsor who has at least one medicine included on the ARTG should complete this survey. Medicine sponsors that do not complete the survey will be assigned the highest survey risk score, meaning you have a very high chance of receiving a PV Inspection under the TGA's PVIP.
The TGA's Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is designed to inform the TGA about a sponsor's medicine portfolio, pharmacovigilance system, inspection history and compliance with Australian pharmacovigilance legislation and guidelines, and will serve as a tool to help prioritise and schedule pharmacovigilance inspections.
Sponsors are directed to complete and submit their survey responses online; the survey consists of 24 questions and must be completed in one attempt only. Partially completed surveys will not be recorded and cannot be retrieved for later use. After completing the survey, a message will be displayed on your screen saying that your response has been recorded. You may also download a copy of your responses for your own records (please note that a copy of your responses will not be sent to your e-mail).
The TGA request that stakeholders answer the questions carefully and truthfully as they may ask for evidence of responses during a pharmacovigilance inspection.
A copy of the survey questions is provided to assist stakeholders prepare their responses prior to submission.
Please visit the TGA website for more information, to access the survey questions and respond to the survey.