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Notice of Product Change
1. Person Submitting Form
Name *
Email *
Title
Contact Phone *
2. Current Product Information
Supplier Name *
Brand Name *
Generic Name *
Strength *
Dosage Form *
Caplet
Capsule
Inhalation
Inhalation Powder
Inhalation Solution
Injection
Oral Solution
Oral Suspension
Patch
Powder
Suppository
Tablet
Topical Cream
Topical Lotion
Topical Ointment
Vaginal Insert
Please include pictures of current product and new product, clearly labeled. Include as many as necessary. Accepted file types: PNG, JPEG, PDF
Images
Packaging Format *
Ampoule
Bag
Blister Pack
Bottle
Box
Cartridge
Iv Bag
Jar
Kit
Minim
Nebule
Pen
Plastic Ampoule
Prefilled Syringe
Sachet
Tube
Vial
Unit Dose Package
Package Size (e.g. box of 10 vials) *
Effective Date (First of Code Date) *
Date new product will be in general circulation *
Please provide the reason(s) for the changes
3. Product Code Changes
Manufacturer Product Code
Current
Future
McKesson Product Code
Current
Future
CPDN Product Code
Current
Future
Other Distributor Code
Current
Future
Distributor Name
4. Health Canada License Number Change
Drug Identification Number (DIN)
Current
Future
Natural Product Number (NPN)
Current
Future
Medical Device License (MDL)
Current
Future
5. GTIN and Barcode Change
GTIN on Unit of Purchase
Current
Future
GTIN on Unit of Use
Current
Future
GTIN on Case
Current
Future
Change in type of Barcode
Current
No Barcode
Linear
Data Matrix
Future
No Barcode
Linear
Data Matrix
6. Please indicate any changes to the format of your product
Current
Ampoule
Bag
Blister Pack
Bottle
Box
Cartridge
Iv Bag
Jar
Kit
Minim
Nebule
Pen
Plastic Ampoule
Prefilled Syringe
Sachet
Tube
Vial
Unit Dose Package
Future
Ampoule
Bag
Blister Pack
Bottle
Box
Cartridge
Iv Bag
Jar
Kit
Minim
Nebule
Pen
Plastic Ampoule
Prefilled Syringe
Sachet
Tube
Vial
Unit Dose Package
*For a product to be considered unit dose, it requires the following details for each individually wrapped tablet/capsule/liquid dose: generic name, strength, DIN, lot number, expiry date and name of manufacturer
7. Please describe any changes to the actual product appearance
Change in colour
Current
Future
Change in shape
Current
Future
Change to markings
Current
Future
Change to scoring on tablets
Current
Future
Change in dimensions
Current
Future
Change in weight of tablet/capsule/caplet/vial/ampoule
Current
Future
8. Package Size
Dimensions of outer package
Current
Future
Dimensions of inner package
Current
Future
Number of units per package
Current
Future
Change to case: weight
Current
Future
Change to case dimensions: Length/Width/Height
Current
Future
9. Other Changes
Change in concentration
Current
Future
Change in preservative content
Current
Future
Change in excipients or non-medicinal ingredients
Current
Future
Change in reconstitution instructions
Current
Future
Change in storage conditions
Current
Future
Change in stability information
Current
Future
Change in natural rubber latex content
Current
Future
Change to drug container (e.g. vial, ampoule)
Current
Future
Change in security features
Current
Future
Change to branding or other graphics
Current
Future
Other label changes
Current
Future
Other: please specify
Current
Future
I would like to receive the copy of this form.
(Notice of Product Change)