The TGA is seeking comment on the content, presentation and usability of two draft efficacy monographs that have been developed for vitamins B6 and B12 in response to Recommendation 46 from the Review of Medicines and Medical Devices Regulation (MMDR).

These monographs document evidence which substantiates the use of these vitamins for particular indications which are appropriate for listed medicines.

The consultation period on these monographs closes 5:00 PM Friday 26 February 2021.

Please see today's technical alert for more information on the consultation and potential sponsor impacts.