Tech Alert: Transition reminder – Vitamin B6 – maximum dose and warnings; Artemisinin containing ingredients – pregnancy warning statement; Mollusc-derived ingredients – warning 

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



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