Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_431
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 431
Character Range: 214988–217727

431                                       AKKERMANSIA MUCINIPHILA                                                           A         Only to be used in a medicine where Qintet Pharmaceuticals Pty Ltd, (Client ID 84359) is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 27 September 2026.

                                                                                                                                      Only permitted for use in medicines:

                                                                                                                                      (a) limited to oral routes of administration; and

                                                                                                                                      (b) when the strain of Akkermansia muciniphila is confirmed to be:

                                                                                                                                      (i) American Type Culture Collection accession number BAA-835; and/or

                                                                                                                                      (ii) Collection de l'Institut Pasteur accession number 107961.

                                                                                                                                      The strain of Akkermansia muciniphila must be declared on the label.

                                                                                                                                      The maximum recommended daily dose of the medicine must not provide more than 34 billion non-viable cells of pasteurised Akkermansia muciniphila.

                                                                                                                                      The ingredient must not contain more than 10 colony forming units per gram viable Akkermansia muciniphila.

                                                                                                                                      The following warning statements (or words to the same effect) are required on the medicine label:

                                                                                                                                      - (PREGNT) 'Not recommended for use by pregnant and lactating women'; and

                                                                                                                                      - (ADULT) 'Adults only'.