Good Manufacturing Practices - Foreign Site Submission Form - Section 5 (FRM-0212)

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Foreign Site Name and Address Information

Foreign Company Name:
Street:
City:
Province State:
Country:
Postal Code / Zip Code:
Site in MRA country?    Yes / No
Site covered by MRA?   Yes / No

Canadian Building Information (Complete only if submitting Section 5 separately)

Canadian Drug Establishment Name: 
Drug Establishment Licence Number:
Contact (foreign site correspondence):
Telephone:
Fax:
Email:
Name of Authorized Signing Official:   
Title:    
Signature:    
Date: (yyyy-mm-dd)

Activity, Category and Dosage form class information

Activity

1. Fabricate
2. Package/Label
3. Test
   1. Biological
   2. Chemistry
   3. In-process
   4. Microbiology - Sterility
   5. Microbiology - Non-sterility
   6. Physicochemical
   7. Stability
   8. All of the above

Enter only one activity (e.g. 3h) and one category per line. (e.g. 1)

Category

1. Pharmaceuticals
2. Vaccine
3. Blood & Blood Components
4. Biological
5. Radiopharmaceutical
6. (for Wholesalers only) = Schedule F & G, Narcotic

Enter only one activity (e.g. 3h) and one category per line. (e.g. 1)

Dosage Form Class

1. Powder for solution
2. Tablet
3. Capsule
4. Solution
5. Suspension
6. Aerosol
7. Powder
8. Suppository
9. Medical Gas
10. Veterinary Premix
11. Bulk Intermediates (biological only)
12. Active Pharmaceutical Ingredient (API)
13. Packaging Material
14. Other (specify)

Enter all that apply. (S) is used to indicate sterile dosage form. (e.g. 2, 3, 5(S), 14 (cream))

Product Information
Product Name
Class (Human / Vet)
Schedule
Drug Identification Number (DIN)
Activity (F (Fabricate), P (Package), T (Testing))