Document ID: chunk:federal_register_of_legislation:C2024C00632:section:3:p7
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 3 (pt 7/14)
Character Range: 36554–39371

part of that process.
manufacturer, of a medical device, has the meaning given by section 41BG.
manufacturing principles means the principles for the time being having effect under section 36.
manufacturing site means premises:
 (a) that are for use in the manufacture of a particular kind of therapeutic goods; and
 (b) at which the same persons have control of the management of the production of the goods and the procedures for quality control.
manufacturing site authorisation means an authorisation referred to in subsection 38(2B) or 40B(4).
medical device has the meaning given by section 41BD.
medical device classification means a classification specified in the regulations made for the purposes of section 41DB.
medical device standard, in relation to a kind of medical device, means a medical device standard, specified in an order under section 41CB, that is applicable to that kind of medical device.
medical practitioner means a person who is registered or licensed as a medical practitioner under a law of a State or an internal Territory that provides for the registration or licensing of medical practitioners.
medicine means therapeutic goods (other than biologicals) that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human.
member of EFTA means a country declared by the Minister under section 3A to be a member of the European Free Trade Association.
member of the European Community means a country declared by the Minister under section 3A to be a member of the European Community.
mother substance means any of the following:
 (a) an animal;
 (b) a plant;
 (c) an alga;
 (d) a fungus;
 (e) a micro‑organism;
 (f) a mineral;
 (g) a mineral compound;
 (h) a chemical;
 (i) a product obtained from any of the things mentioned in paragraphs (a) to (h).
Mutual Recognition Convention means the Convention for the Mutual Recognition of Inspections in respect of the Manufacture of Pharmaceutical Products done at Geneva on 8 October 1970.
national emergency declaration has the same meaning as in the National Emergency Declaration Act 2020.
non‑EC/EFTA attestation of conformity, for a non‑EC/EFTA MRA, means an attestation of conformity issued, after the non‑EC/EFTA MRA has come into force, by a conformity assessment body that is designated in the non‑EC/EFTA MRA and approved by the Secretary in writing for the non‑EC/EFTA MRA.
non‑EC/EFTA MRA means an international instrument that Australia is bound by, or is a party to, if:
 (a) a purpose of the instrument is the recognition of attestations of conformity; and
 (b) the instrument satisfies the requirements (if any) set out in regulations made for the purposes of this paragraph;
but does not include:
 (c) the