Therapeutic Goods Regulations 1990

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

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