Commonwealth Numbered Regulations Commonwealth Numbered RegulationsPart 1 -- Prescription medicines
Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017
1 Subsection 2(1) (table item 3, columns 2 and 3)
Omit "1 January 2018", substitute "4 December 2017".
Therapeutic Goods Regulations 1990
2 Regulation 2
Insert:
"TGA notifications process guidance document " means Version 2.0 of the document published by the Therapeutic Goods Administration entitled Notifications process--requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 4 December 2017).
Note: The TGA notifications process guidance document could in 2017 be viewed on the Therapeutic Goods Administration's website (http://www.tga.gov.au).
"Therapeutic Goods Administration " means that part of the Department known as the Therapeutic Goods Administration.
3 Paragraph 10AAA(2)(b)
Omit "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)", substitute "the TGA notifications process guidance document".
4 Subregulation 10AAA(2) (note)
Repeal the note.
5 Subregulation 10AAA(2) (at the end of the table)
Add:
| 17 | A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine | LFT |
| 18 |
Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for: (a) use of the medicine; or (b) use of a measuring device; or (c) use of an applicator | RGN |
| 19 | A change to the location of a graphic on the panel of a label for the medicine if: (a) there is no change to the size, shape or colour of the graphic; and (b) the change does not involve reformatting text | LGM |
| 20 | If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine | PSN |
| 21 | If the medicine is in a liquid or semi-solid dosage form, the addition of a new pack size that is within the pack size range for the medicine | PLN |
| 22 |
The deletion of a pack size for the medicine | PSD |
| 23 | If the medicine is sterile: (a) the addition of a manufacturer of the medicine for the performance of any of the following steps: (i) release for supply; (ii) secondary packaging; (iii) chemical, physical or microbial testing; or (b) the inclusion of the performance of any of the steps mentioned in paragraph (a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine | MSS |
| 24 | If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if: (a) other means of accurately measuring the dose are readily available; and (b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and (c) there are no changes to the directions for use of the medicine | KMO |
6 Paragraph 10AAB(2)(b)
Omit "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)", substitute "the TGA notifications process guidance document".
7 Subregulation 10AAB(2) (note)
Repeal the note.
8 Subregulation 10AAB(2) (at the end of the table)
Add:
| 53 | A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine | ASPC |
| 54 | A minor change to: (a) the manufacture of an active pharmaceutical ingredient of the medicine; or (b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or (c) an intermediate of an active pharmaceutical ingredient of the medicine; if the change does not affect any step taken to sterilise the ingredient or intermediate | AMMC |
55 | A change to a label for the medicine that deletes text from side or rear panels if: (a) the text is present elsewhere on the label for the medicine; and (b) repetition of the information on the panel is not required by an order in force under subsection 10(1) of the Act, or a condition imposed by or under section 28 of the Act, that applies to the medicine | LPDR |
| 56 | A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine | LPCS |
| 57 | A change to a label for the medicine to include, remove or change the sponsor's or distributor's logo or livery |
LPCL |
| 58 | A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form | LPDG |
| 59 | A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form | LPCP |
| 60 | A change to a label for the medicine to include: (a) simple instructions or information relating to the packaging of the medicine; or (b) information describing a change in appearance of the dosage form | LPIA |
| 61 | A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine | LPOP |
| 62 | A change to a label for the medicine as a consequence of: (a) a variation, under subsection 9D(3) of the Act, of the entry in the Register that relates to the medicine; or (b) a condition imposed, under subsection 28(3) of the Act, on the listing or registration of the medicine | LOCI |
| 63 | A change to a label for the medicine that removes phrases indicating novelty, such as "New formulation" or "New appearance" | LPRP |
| 64 | A change to a label for the medicine to include a QR code, if the link is: (a) to a website owned by the person in relation to whom the medicine is included in the Register; and (b) to information that is non-promotional | LPQR |
| 65 | A change to a label for the medicine to include information about a patient support program |
LPPS |
9 Paragraph 10AAC(2)(b)
Omit "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)", substitute "the TGA notifications process guidance document".
10 Subregulation 10AAC(2) (note)
Repeal the note.
11 Subregulation 10AAC(2) (at the end of the table)
Add:
11 | A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent | ISNL |
| 12 | A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the drug substance or excipient; or (b) an order in force under subsection 10(1) of the Act that applies to the drug substance or excipient | ISPT |
| 13 | A change to a method used for testing a drug substance or excipient of the medicine if: (a) the change is to adopt a method in a default standard; and (b) the test is not for viral safety |
ISAM |
| 14 | A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard | PSNT |
| 15 | 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 | PSPT |
| 16 | A minor change to a physicochemical test method used for testing the medicine | PMPL |
| 17 | The replacement of an in-house reference standard with another if the protocol and acceptance criteria for establishing a replacement in-house reference standard have been approved by the Therapeutic Goods Administration | IRSR |
| 18 | A change to a label for the medicine that deletes text from a side or rear panel if: (a) the text is present elsewhere on the label for the medicine; and (b) repetition of the information on the panel is not required by an order in force under subsection 10(1) of the Act, or a condition imposed by or under section 28 of the Act, that applies to the medicine | LPDR |
|
19 | A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine |
LPCS |
| 20 | A change to a label for the medicine to include, remove or change the sponsor's or distributor's logo or livery | LPCL |
| 21 | A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form | LPDG |
| 22 | A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form | LPCP |
|
23 | A change to a label for the medicine to include: (a) simple instructions or information relating to the packaging of the medicine; or (b) information describing a change in appearance of the dosage form | LPIA |
24 | A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine | LPOP |
| 25 | A reduction in the shelf life of the drug substance of the medicine | ASRS |
| 26 | A reduction in the shelf life of the medicine | PSLD |
| 27 | The introduction of anti-tamper packaging if the packaging material is not in contact with the medicine | PPAT |
| 28 | Either or both of the following changes to the manufacture of the medicine: (a) removal of a temperature excursion; (b) reduction in the time spent out of refrigeration or freezer storage | PSET |
29 | The addition of a storage condition for the medicine | PSAR |
| 30 | A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed | OAMS |
12 After regulation 10AAC
Insert:
10AAD Variation of entries in Register--biologicals
Kinds of variations
(1) For the purposes of paragraph 9D(3AC)(b) of the Act, a variation:
(a) of an entry in the Register that relates to a biological; and
(b) that is listed in the table in subregulation (2);
is specified.
Conditions
(2) For the purposes of paragraph 9D(3AC)(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 1 of an item in the following table:
(a) the variation reflects a change that will be made to, or in relation to, the biological;
(b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.
| Kinds of variations--biologicals | ||
| Item |
Column 1 Variation | Column 2 Code |
| 1 | A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with: (a) a default standard that applies to the biological; or (b) an order in force under subsection 10(1) of the Act that applies to the biological | PT |
| 2 | A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent | DS |
| 3 | A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit's ability to detect an infectious disease | TK |
4 | A change to a critical material used in the manufacture of the biological if: (a) the critical parameters for the changed material are equivalent or of greater quality; and (b) the material is not of human or animal origin; and (c) the material is not an excipient; and (d) in the case of critical material that is a container for the biological--the change is not a change to the composition of the material | SM |
| 5 | The introduction of more stringent limits to an in-process control test applied during the manufacture of the biological | MI |
| 6 | The removal of a product if the biological is a Class 2 biological | BR |
| 7 | The addition of a site at which secondary packaging or storage of the biological is performed | MA |
| 8 | A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological: (a) quality control testing; (b) infectious disease testing | MT |
| 9 | The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site | MR |
10 | The introduction of more stringent limits to a release test applied during the manufacture of the biological | BS |
| 11 | A reduction in the shelf life or shipping timeframe of the biological | BT |
| 12 | A change to the label or supporting documentation for the biological to: (a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or (b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient | LC |