Commonwealth Numbered Regulations Commonwealth Numbered RegulationsPart 1 -- Registered complementary medicines and registered OTC medicines
Therapeutic Goods Regulations 1990
1 After regulation 10
Insert:
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 registered complementary medicine or registered OTC 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--registered complementary medicines and registered OTC medicines | ||
| Column 1 | Column 2 | Column 3 |
| Item | Variation | Code |
| 1 | The addition of a flash including the term "new" or "value pack" to a label or package insert for the medicine | LLN |
| 2 | If the name of the medicine's sponsor is not included in the name of the medicine, a change to the sponsor's details (including the sponsor's logo) that are included in a label or package insert for the medicine | LSP |
| 3 | A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive | PSC |
|
4 | A decrease in the shelf life of the medicine included in a label or package insert for the medicine | PSR |
| 5 | A reduction or removal of an overage for an active ingredient of the medicine | AOV |
| 6 | A change to the type of starch (if any) used as an excipient in the medicine | EST |
| 7 |
Either of the following: (a) if the specifications for the medicine incorporate a default standard--the replacement of that default standard with another default standard; (b) if the specifications for the medicine include in-house tests--the replacement of those tests with a default standard | QFP |
8 | Either of the following: (a) if the specifications for the starting materials of the medicine incorporate a default standard--the replacement of that default standard with another default standard; (b) if the specifications for the starting materials of the medicine include in-house tests--the replacement of those tests with a default standard | QSP |
| 9 | If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made: (a) if the material is polyvinyl chloride--a change to: (i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or (ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene; (b) if the material consists of polyvinyl chloride and polyvinylidene chloride--a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene; (c) if the material is used in a plastic component of the blister pack--a change to a material with demonstrated equal or lesser water permeability | KBL |
| 10 | If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made: (a) if the material is polystyrene--a change to polyvinyl chloride, polyethylene, polypropylene or glass; (b) if the material is polyvinyl chloride--a change to polyethylene, polypropylene or glass; (c) if the material is polyethylene: (i) an increase in the material's density; or (ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre; (d) if the material is glass--a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre; (e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre--a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre | KBT |
| 11 | A change to the closure system for the medicine, unless: (a) the closure system also functions as a metering component of the medicine; or (b) the change involves a change to the pump, or components of the pump, of a metered-dose aerosol | KCL |
| 12 | If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack | KRR |
| 13 | If the medicine is non-sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine | AMS |
| 14 | If the medicine is non-sterile, the manufacture of the medicine at an additional site | MMA |
| 15 | The cessation of the manufacture of the medicine by a manufacturer | MMD |
| 16 | A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine |
MSD |
2 Clause 3 of Schedule 9 (table item 2A, column 2)
After "section 9D", insert "(other than subsection 9D(2C)".
3 Clause 3 of Schedule 9 (after table item 2CA)
Insert:
| 2CB | Fee for a request under subsection 9D(2C) of the Act (other than a request to which item 2CC or 2CD applies) to make one or more variations of one or more entries in the Register in relation to a medicine--for each entry | 780 |
| 2CC | 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 that each relate to a registered complementary medicine--for each group of up to 7 entries | 780 |
| 2CD |
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 that each relate to a registered OTC medicine--for each group of up to 7 entries | 780 |
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 |