*Manufacture of Specialist Products for Hospitals

The Australian Therapeutic Goods Act (1989) (Regulations) allows hospitals and other public institutions to order the production of a special manufacture of a pharmaceutical for their use. To do this, the hospital enters into a contract with an appropriately licenced Pharmaceutical Company. Pharmalab is able to undertake this manufacture as a licenced Australian manufacturer.

Schedule 5A Regulation of the Therapeutic Goods Act (1989)

Therapeutic Goods Regulations

Schedule 5A – Subregulation 12(1A)

The relevent section of the Regulations allows manufacture under the following provisions:

States: Therapeutic goods, other than goods referred to in item 3 are:
(a) manufactured by a person:
(i) under a contract between the person and a private hospital, public hospital or public institution, in a State or Territory; and in accordance with a formulation specified by the private hospital, public hospital or public institution, in a State of Territory; and for use by, or in connection with, a patient of a private hospital, public hospital or public institution in the same State of Territory

Regulations:

(a) there are no listed goods or registered goods that, in all relevant respects, are substantially similar to the goods; and the person:

(b) (1) manufactures the goods at premises in Australia; and

(2) holds a licence, required by the Act, that authorises the manufacture, or a step in the manufacture, of the goods at those premises; and

(c) the person notifies the Secretary, in accordance with a form approved by the Secretary, and within 15days of the end of a quarter, of:

(1) the goods manufactured under the contract during that quarter, and
(2) the private hospital, public hospital or public institution that entered the contract