ARCHIVED - Guidance for Pre-manufacturing and Pre-exportation Notifications under Canada's Access to Medicines Regime

GUIDE-0072

(December 1st, 2007)

Unit name: Drug GMP Inspection Unit
Telephone: 613-957-1492
Fax: 613-957-6709
E-Mail: ATM_questions_AAM@hc-sc.gc.ca

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Division 7 Notification Form

1. This serves to notify Health Canada as required by section C.07.011 of the Food and Drug Regulations.

2. The drug product which is the subject of this notification is____________________
(brand name of the drug product, name of the drug product as set out in Schedule 1 of the Patent Act and, if applicable, the strength, dosage form and route of administration of the drug product),
with Export Tracking Number____________________.

3. This notification pertains to (check one only):

the manufacturing of the first lot of the above named drug product.
The lot number is____________________.

OR

the exportation of a subsequent lot of the above named drug product.
The lot number is____________________.

check box
check box

4. The quantity of the above named drug product to be exported for the lot in question is____________________.

5. The name and address of the manufacturer are as follows:____________________

6. The name, title, address and phone number of the undersigned authorized representative of the manufacturer are:____________________

Dated at___________ the___________ day of___________,___________.

_____________________________________
Authorized representative of the manufacturer

Send the completed, signed and dated form by fax or by e-mail to:

Manager, Drug GMP Inspection Unit
HPFB Inspectorate
Health Product and Food Branch
Health Canada
Fax #: 613-957-6709
E-mail Address: ATM_questions_AAM@hc-sc.gc.ca

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