Document ID: chunk:federal_register_of_legislation:F2025C00036:front:0:p3
Version: federal_register_of_legislation:F2025C00036
Segment Type: other
Provision Reference: 
Character Range: 5707–9100

and distinguish certain medicines from other therapeutic goods
11A Characteristics that separate and distinguish certain biologicals from other biologicals
12 Exempt goods
12A Unapproved medicines and biological—exemption in life‑threatening cases
12AAB Disposal of unused emergency goods and unused emergency biologicals
12AA Applications for special and experimental uses
12AB Goods imported etc for experimental uses
12AC Powers of authorised officers in relation to goods imported etc for experimental uses
12AD Use of goods for experimental purposes—specified conditions
12B Exemptions for certain uses—medicines
12BA Authorities for certain uses—therapeutic vaping substances that are not medicines
12C Exemptions for health practitioners—biologicals
15 Application of registration or listing number to goods
15AA Clinical trial registries
15A Conditions of registration and listing of medicines
16AA Information or documents that Secretary may require
16AB Specified periods
Part 3A—Applications for evaluation
Division 1—Preliminary
16A Interpretation—working day
Division 1A—Goods mentioned in Part 1 of Schedule 10
16C Applications for registration—notification of effectiveness and period for completing evaluations—general
16D Applications for variations—notification of effectiveness and period for deciding applications—general
16DA Conditions for periods for regulations 16C and 16D
16E Applications for variations—effect of failure to decide applications within specified period
16F Applications for variations—shorter period for deciding applications
16G Applications for registration—shorter period for completing evaluations
Division 2—Applications for evaluation of substances
16GA Evaluation other than evaluation under subsection 9D(1), (2) or (3) or section 25 of the Act
Division 3—Class 2, Class 3 and Class 4 biologicals
16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made
16GD Notification of effective request and period within which certain applications must be decided
16GE Failure to decide an application within specified time
16GF Evaluation, other than evaluation under subsection 9D(3A) or (3AA) or section 32DE of the Act
Division 4—Complementary medicines and certain other listed medicines
16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made
16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed
16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made
16GIA Period for paying evaluation fee for application under subsection 26BD(1) of the Act
16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications
Part 3B—Designated orphan drugs
16H Application to designate medicine as orphan drug
16J Designation of medicine as orphan drug
16K Period during which designation is in force
16L Extension of designation
16M Revocation of designation
Part 3C—Therapeutic goods (priority applicant) determinations
16P Application of Part
16Q Application for therapeutic goods (priority applicant) determination
16R Making