Members are reminded that the end of the transition period for existing products that contain Vitamin B6, certain Artemisinin containing ingredients and Mollusc-derived ingredients is 28 Feb 2023. Sponsors have been provided a 12-month transition period from 1 March 2022 to bring existing listed medicines into compliance. From 1 March 2023:
- The maximum recommended daily dose (MRDD) for products that contain vitamin B6 has been changed to 100 mg pyridoxine/day. Existing products that contain vitamin B6 must include a warning statement if the medicine contains more than 10 mg of pyridoxine per maximum recommended daily dose (MRDD).
- Existing products that contain certain Artemisinin containing ingredients must include a pregnancy warning statement.
- Existing products that contain Mollusc derived ingredients must include a new warning statement.
Please read today’s technical alert for more details