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Published in Commonwealth of Australia Special Gazette No. S 295, Thursday 19 July 2001
COMMONWEALTH OF AUSTRALIA
THERAPEUTIC GOODS ACT 1989
THERAPEUTIC GOODS REGULATIONS
I, PIO CESARIN, delegate of the Secretary to the Department of Health and Aged Care for the purposes of subregulation 9(2) of the Therapeutic Goods Regulations, give notice that I approve the use of the prohibited representation described in paragraph (a) below:
- for inclusion on the label of therapeutic goods described in paragraph (b) below, and
- for inclusion in information included in the package in which the therapeutic goods described in paragraph (b) below are contained:
- "Individuals who are using prescription anti-depressants or suffer from bipolar depression should not use this product unless under the supervision of a health practitioner";
- (S)-S-adenosylmethionine, in the form of sulfate, tosylate or mixed sulfate/tosylate salts, and ademetionine in the form of sulfate, tosylate or mixed sulfate/ tosylate salts
My approval takes effect from the date this notice is gazetted in the Commonwealth Gazette.
Dated this 17th day of July 2001
Chemicals and Non-prescription Medicines Branch
Therapeutic Goods Administration