Commonwealth Numbered Regulations

THERAPEUTIC GOODS LEGISLATION AMENDMENT (2019 MEASURES NO. 1) REGULATIONS 2019 (F2019L01660) - SCHEDULE 5

Therapeutic Goods Regulations 1990

1  Regulation 2

Insert:

"faecal microbiota transplant product " means a thing that:

                     (a)  comprises, contains or is derived from human stool; and

                     (b)  is for introduction into a person for a therapeutic use.

2  Before clause 1 of Schedule 16

Insert:

1A   Class 1 biologicals

                   For the purposes of the definition of Class 1 biological in regulation 2, a biological is a Class 1 biological if:

                     (a)  it is a faecal microbiota transplant product; and

                     (b)  it is not advertised to consumers; and

                     (c)  it is to be collected under the supervision or direction, or in accordance with the requirements, of a medical practitioner registered, in a State or internal Territory, as a medical practitioner; and

                     (d)  each later step in the manufacture of it is to be carried out in a hospital by, or under the supervision or direction of, the practitioner (unless the step relates to the storage or testing of the biological, in which case it may instead be carried out by a person under a contract with the hospital in a State or internal Territory); and

                     (e)  it is for use in a recipient who is a patient of the hospital with the recipient being under the clinical care of the practitioner.