Document ID: chunk:federal_register_of_legislation:C2024C00632:section:3:p4
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 3 (pt 4/14)
Character Range: 28786–31702

directions for use, in relation to therapeutic goods, includes information on:
 (a) appropriate doses of the goods; and
 (b) the method of administration or use of the goods; and
 (c) the frequency and duration of treatment for each indication of the goods; and
 (d) the use of the goods by persons of particular ages or by persons having particular medical conditions.
EC/EFTA attestation of conformity means an attestation of conformity (within the meaning of the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement) issued by an EC/EFTA conformity assessment body that is approved by the Secretary in writing.
EC/EFTA conformity assessment body means a Conformity Assessment Body designated in one of the following Sectoral Annexes to the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement:
 (a) Sectoral Annex (Medical Devices);
 (b) Sectoral Annex (Medicinal Products GMP Inspection and Batch Certification).
EC Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Community, as in force from time to time.
EFTA Mutual Recognition Agreement means the Agreement on Mutual Recognition in relation to Conformity Assessment, Certificates and Markings between Australia and the European Free Trade Association, as in force from time to time.
essential principles has the meaning given by section 41CA.
ethics committee means a committee:
 (a) constituted and operating as an ethics committee in accordance with guidelines issued by the CEO of the National Health and Medical Research Council as in force from time to time; and
 (b) which has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992.
European Pharmacopoeia means the English edition of the publication of that name, including any additions or amendments, that was in effect immediately before the commencement of this definition and, if additions or amendments of that publication are made after that commencement, or new editions of that publication are published after that commencement, includes those additions or amendments, or those new editions, from the effective date published by the Council of Europe or any replacement body.
evidential burden, in relation to a matter, means the burden of adducing or pointing to evidence that suggests a reasonable possibility that the matter exists or does not exist.
exempt device means a medical device that is of a kind that is exempted from Division 3 of Part 4‑11 by the regulations.
exempt goods, in relation to a provision of Part 3‑2, means therapeutic goods that are exempted from the operation of that Part (except section 31A and sections 31C to 31F) by the regulations.
exempt goods, in relation to a provision of Part 3‑3, means therapeutic goods