Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017
made under the
Therapeutic Goods Act 1989
Compilation No. 1
Compilation date: 2 December 2017
Includes amendments up to: F2017L01561
Registered: 13 December 2017
About this compilation
This compilation
This is a compilation of the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017 that shows the text of the law as amended and in force on 2 December 2017 (the compilation date).
The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.
Uncommenced amendments
The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.
Application, saving and transitional provisions for provisions and amendments
If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.
Editorial changes
For more information about any editorial changes made in this compilation, see the endnotes.
Modifications
If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.
Self‑repealing provisions
If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.
Contents
1 Name
2 Commencement
3 Authority
4 Schedules
Schedule 1—Variation of entries in Register
Part 2—Prescription medicines
Therapeutic Goods Regulations 1990
Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
1 Name
This instrument is the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017.
2 Commencement
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information | ||
Column 1 | Column 2 | Column 3 |
Provisions | Commencement | Date/Details |
1. Sections 1 to 4 and anything in this instrument not elsewhere covered by this table | 1 July 2017. | 1 July 2017 |
2. Schedule 1, Part 1 | 1 July 2017. | 1 July 2017 |
3. Schedule 1, Part 2 | 4 December 2017. | 4 December 2017 |
4. Schedules 2 to 9 | 1 July 2017. | 1 July 2017 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
3 Authority
This instrument is made under the Therapeutic Goods Act 1989.
4 Schedules
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1—Variation of entries in Register
Part 2—Prescription medicines
Therapeutic Goods Regulations 1990
4 Regulation 2
Insert:
biological medicine means:
(a) a medicine (other than an antibiotic) that is:
(i) a vaccine, a peptide, a protein or polysaccharide‑based; and
(ii) derived from a human, animal or other organism, or produced through recombinant technology or biotechnology; and
(iii) of a kind specified in item 1 of Part 1 of Schedule 10; or
(b) a medicine that is a human blood product of a kind mentioned in Appendix A in Part 5 of the Poisons Standard.
5 After regulation 10AAA
Insert:
10AAB Variation of entries in Register—prescription medicines other than biological medicines
Kinds of variations
(1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.
Conditions
(2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:
(a) the variation reflects a change that will be made to, or in relation to, the medicine;
(b) the other conditions set out in Version 1.0 of the document entitled Notifications process—requests to vary registered medicines where quality, safety and efficacy are not affected (as in force on the day this regulation commences) in relation to the code listed in column 3 of the item are satisfied.
Note: Version 1.0 of the document entitled Notifications process—requests to vary registered medicines where quality, safety and efficacy are not affected can be found on the Therapeutic Goods Administration website at http://www.tga.gov.au.
Kinds of variations—prescription medicines other than biological medicines | ||
Column 1 | Column 2 | Column 3 |
Item | Variation | Code |
1 | A change to the container or closure system used to store a non‑sterile active pharmaceutical ingredient of the medicine | ACCS |
2 | A change to the synthesis of an active pharmaceutical ingredient of the medicine if: (a) the ingredient is not a synthetic polypeptide; and (b) the ingredient is not prepared by fermentation; and (c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and (d) the Directorate: (i) has issued a revised certificate of suitability in relation to the ingredient; or (ii) has declared that the ingredient does not require a revised certificate of suitability | ACEP |
3 | A change to the size of a manufacturing batch of a non‑sterile active pharmaceutical ingredient, or a non‑sterile intermediate of such an ingredient, of the medicine | AMBS |
4 | The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site | AMCS |
5 | The introduction, revision or discontinuation of: (a) an in‑process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or (b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate | AMIT |
6 | A minor change to the manufacture of an active pharmaceutical ingredient of the medicine, or an intermediate of such an ingredient, if the change does not affect any step taken to sterilise the ingredient or intermediate | AMMC |
7 | If an active pharmaceutical ingredient of the medicine is manufactured by multi‑step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation): (a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or (b) the manufacture of such an intermediate at an additional site | AMMF |
8 | The transfer of the manufacture of a non‑sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if: (a) the ingredient is not prepared by fermentation; and (b) the ingredient is a pure chemical entity; and (c) the ingredient is prepared: (i) by chemical synthesis; or (ii) through isolation from a natural source | AMTA |
9 | A change to a non‑biological method used for assaying or residual solvent testing (including testing for water) any of the following: (a) an active pharmaceutical ingredient of the medicine; (b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; (c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient | ASAM |
10 | Either of the following: (a) a shortening of the re‑test period for an active pharmaceutical ingredient of the medicine; (b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine | ASDR |
11 | A change to an identification test used in relation to: (a) an active pharmaceutical ingredient of the medicine; or (b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or (c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient | ASID |
12 | A change to the specifications for: (a) an active pharmaceutical ingredient of the medicine; or (b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or (c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient; if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent | ASNL |
13 | A change, resulting from the addition of a new test and its associated limits, to the specifications for: (a) an active pharmaceutical ingredient of the medicine; or (b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or (c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient | ASNT |
14 | A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the medicine; or (b) an order in force under subsection 10(1) of the Act that applies to the medicine | ASPT |
15 | A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form | DMBS |
16 | A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is: (a) semi‑solid or liquid; and (b) not a modified release dosage form | DMEL |
17 | A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is: (a) nasal or oral inhalation; and (b) not a modified release dosage form | DMEO |
18 | A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is: (a) solid; and (b) not a modified release dosage form | DMES |
19 | The introduction, revision or discontinuation of: (a) an in‑process control test applied during the manufacture of the medicine; or (b) a limit associated with an in‑process control test applied during the manufacture of the medicine | DMIT |
20 | A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form | DMRO |
21 | A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is: (a) sterile; and (b) not a modified release dosage form | DMSE |
22 | The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site | DMDM |
23 | Any of the following: (a) if the dosage form of the medicine is sterile: (i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or (ii) the performance of those things at an additional site; (b) if the dosage form of the medicine is not sterile: (i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or (ii) the performance of those things at an additional site | DMPL |
24 | If the dosage form of the medicine is: (a) non‑sterile semi‑solid or non‑sterile liquid; and (b) not a modified release dosage form; either of the following: (c) a change to the location of a site where the medicine is manufactured; (d) the manufacture of the medicine at an additional site | DMSL |
25 | If the dosage form of the medicine is: (a) non‑sterile oral, or non‑sterile nasal, inhalation; and (b) not a modified release dosage form; either of the following: (c) a change to the location of a site where the medicine is manufactured; (d) the manufacture of the medicine at an additional site | DMSO |
26 | If the dosage form of the medicine is: (a) non‑sterile solid; and (b) not a modified release dosage form; either of the following: (c) a change to the location of a site where the medicine is manufactured; (d) the manufacture of the medicine at an additional site | DMSS |
27 | Either of the following: (a) a change to the location of a site where either of the following are performed in relation to the medicine: (i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing); (ii) release for supply; (b) the performance of either of the following in relation to the medicine at an additional site: (i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing); (ii) release for supply | DMTR |
28 | A change to a non‑biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical | DSAM |
29 | A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine | DSID |
30 | A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine | DSIP |
31 | A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent | DSNL |
32 | The addition of a new test and limits associated with the test to the specifications for the medicine | DSNT |
33 | A minor change to a method used to test physiochemical parameters of the medicine | DSPL |
34 | A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the medicine; or (b) an order in force under subsection 10(1) of the Act that applies to the medicine | DSPT |
35 | A change to a method used to test the sterility of the medicine | DSST |
36 | If: (a) the medicine is not administered by the parenteral, ophthalmic or intra‑tracheal route; and (b) the source of an excipient in the medicine is Category IC ruminant tissue; any of the following: (c) a change in the source of the excipient to a non‑animal source; (d) a change in the manufacturing process of the excipient; (e) a change to the location of a manufacturing site | EMRS |
37 | A change to a method used to assay an excipient in the medicine | ESAM |
38 | A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient | ESIP |
39 | A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent | ESNL |
40 | A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine | ESNT |
41 | A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the medicine; or (b) an order in force under subsection 10(1) of the Act that applies to the medicine | ESPT |
42 | A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine | CCCA |
43 | A change to the size or shape of a container or closure system for the medicine if the medicine is non‑sterile | CCSS |
44 | Any of the following changes to the specifications for a container or closure system for the medicine: (a) the inclusion of a new test; (b) making a limit more stringent; (c) the deletion of a test procedure; (d) a minor change to a test method | CCST |
45 | If the dosage form of the medicine is non‑sterile, and solid or semi‑solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine | CMDT |
46 | An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is: (a) non‑sterile; and (b) solid, semi‑solid, semi‑liquid or liquid | CMIT |
47 | A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection 10(1) of the Act that applies to the medicine) | LQAE |
48 | A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation | LQAT |
49 | A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large‑volume injection | LQHI |
50 | A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch | LQRT |
51 | A change to a label for the medicine to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous | LWAH |
52 | A change to a label for the medicine to include a warning or cautionary statement if: (a) the Secretary, under subsection 9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and (b) the Secretary, under subsection 25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection 25AA(1) of the Act to add that warning or cautionary statement | LWSR |
10AAC Variation of entries in Register—biological medicines
Kinds of variations
(1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.
Conditions
(2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:
(a) the variation reflects a change that will be made to, or in relation to, the medicine;
(b) the other conditions set out in Version 1.0 of the document entitled Notifications process—requests to vary registered medicines where quality, safety and efficacy are not affected (as in force on the day this regulation commences) in relation to the code listed in column 3 of the item are satisfied.
Note: Version 1.0 of the document entitled Notifications process—requests to vary registered medicines where quality, safety and efficacy are not affected can be found on the Therapeutic Goods Administration website at http://www.tga.gov.au.
Kinds of variations—biological medicines | ||
Column 1 | Column 2 | Column 3 |
Item | Variation | Code |
1 | A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent | PSNL |
2 | A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine | PSQC |
3 | The release for supply of the medicine at an additional site | PMRS |
4 | A reduction in the column life of columns used in the purification process for the medicine | PPCR |
5 | A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma‑derived | PPHR |
6 | A change to the manufacturer of a filter used in a fermentation process for the medicine | FPFM |
7 | The introduction of more stringent internal controls on a fermentation process for the medicine | FPNC |
8 | A reduction in the time required to culture and harvest the cell line for the medicine | FPRP |
9 | A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine | PFCR |
10 | The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine | PFSC |
6 Clause 3 of Schedule 9 (table item 2CB, column 2)
Omit “item 2CC or 2CD”, substitute “item 2CC, 2CD or 2CE”.
7 Clause 3 of Schedule 9 (after table item 2CD)
Insert:
2CE | Fee for a request under subsection 9D(2C) of the Act to make the same variation or variations of 2 or more entries in the Register if: (a) each entry relates to a prescription medicine or a biological medicine; and (b) 2 or more of those medicines have the same active ingredient | The sum of: (a) for each group of entries relating to medicines with the same active ingredient—780; and (b) for any other entry—780 |
Endnotes
Endnote 1—About the endnotes
The endnotes provide information about this compilation and the compiled law.
The following endnotes are included in every compilation:
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
Abbreviation key—Endnote 2
The abbreviation key sets out abbreviations that may be used in the endnotes.
Legislation history and amendment history—Endnotes 3 and 4
Amending laws are annotated in the legislation history and amendment history.
The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.
The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.
Editorial changes
The Legislation Act 2003 authorises First Parliamentary Counsel to make editorial and presentational changes to a compiled law in preparing a compilation of the law for registration. The changes must not change the effect of the law. Editorial changes take effect from the compilation registration date.
If the compilation includes editorial changes, the endnotes include a brief outline of the changes in general terms. Full details of any changes can be obtained from the Office of Parliamentary Counsel.
Misdescribed amendments
A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.
If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.
Endnote 2—Abbreviation key
ad = added or inserted | o = order(s) |
am = amended | Ord = Ordinance |
amdt = amendment | orig = original |
c = clause(s) | par = paragraph(s)/subparagraph(s) |
C[x] = Compilation No. x | /sub‑subparagraph(s) |
Ch = Chapter(s) | pres = present |
def = definition(s) | prev = previous |
Dict = Dictionary | (prev…) = previously |
disallowed = disallowed by Parliament | Pt = Part(s) |
Div = Division(s) | r = regulation(s)/rule(s) |
ed = editorial change | reloc = relocated |
exp = expires/expired or ceases/ceased to have | renum = renumbered |
effect | rep = repealed |
F = Federal Register of Legislation | rs = repealed and substituted |
gaz = gazette | s = section(s)/subsection(s) |
LA = Legislation Act 2003 | Sch = Schedule(s) |
LIA = Legislative Instruments Act 2003 | Sdiv = Subdivision(s) |
(md) = misdescribed amendment can be given | SLI = Select Legislative Instrument |
effect | SR = Statutory Rules |
(md not incorp) = misdescribed amendment | Sub‑Ch = Sub‑Chapter(s) |
cannot be given effect | SubPt = Subpart(s) |
mod = modified/modification | underlining = whole or part not |
No. = Number(s) | commenced or to be commenced |
Endnote 3—Legislation history
Name | Registration | Commencement | Application, saving and transitional provisions |
Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017 | 30 June 2017 (F2017L00853) | Sch 1 (items 4–7): 4 Dec 2017 (s 2(1) item 3) |
|
Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017 | 1 Dec 2017 (F2017L01561) | Sch 2 (item 1): 2 Dec 2017 (s 2(1) item 3) | — |
Endnote 4—Amendment history
Provision affected | How affected |
s 2..................... | am F2017L01561 |
Schedule 1 |
|
Part 1................... | rep LA s 48C |
Schedule 2................ | rep LA s 48C |
Schedule 3................ | rep LA s 48C |
Schedule 4................ | rep LA s 48C |
Schedule 5................ | rep LA s 48C |
Schedule 6................ | rep LA s 48C |
Schedule 7................ | rep LA s 48C |
Schedule 8................ | rep LA s 48C |
Schedule 9................ | rep LA s 48C |