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Tech Alert: [NEUR] warning on listed medicines with folic acid indicated for neural tube defects

10 Sep 2021 10:02 AM | Anonymous member (Administrator)

Please be aware that currently, neither the Therapeutic goods Permissible Ingredients Determination (No. 2) 2021, nor the Therapeutic goods Permissible Ingredients Determination (No. 1) 2021

Do not exceed the stated dosage except on medical advice. If you have had a baby with a neural tube defect/spina/bifida, seek specific medical advice (or words to that effect).

The change occurred in March of this year, and was not subject to public or targeted consultation before it was made. Therefore listed medicine sponsors making new or updated products since March may not have been aware of the change or to the ongoing need to include the statement on products which contain the following permitted indication:

Help to prevent neural tube defects such as spina bifida and/or anencephaly (for medicines where the recommended daily dose of the medicine provides a minimum of 400 micrograms of folic acid).

We recommend that if you have listed (or re-listed) a pregnancy or folic acid product in 2021, that you check the label for the inclusion of the NEUR statement, and if currently listing products, to include the statement until such time as the TGA completes a review of the change that occurred, and conduct any updates to the above documents as needed.

Within this context of review, clarification is also being sought on required applicability of the VIT label statement as it relates to this particular indication in respect of the 2020 Pregnancy Care Guidelines and we will provide any relevant update as available.

For any questions or product related issues, please contact technical@cmaustralia.org.au for support.

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