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