Notice

Contact: Policy Bureau Enquiries

June 21, 2007

Our file number: 07-114894-308

Re: Drug Product Formulation Request

In your 2007 Annual Notification package, a Notice was enclosed advising that Health Canada is requesting all DIN holders and manufacturers of radiopharmaceuticals to provide a current listing of their product formulation, including medicinal and non-medicinal ingredients, and information concerning the sources of these ingredients (such as animal - species, age, country of origin, and tissues and fluids).

The attached package includes the following:

1. A Drug Product Information Form ; and
2. Guidance and Questions and Answers document with instructions for completion and return of the Drug Product Information Form, and information on this request.

If your company no longer acts on behalf of the DIN owner, please return the package as soon as possible to the following address:

Submission & Information Policy Division
Therapeutic Products Directorate
Finance Building, AL 0201A1
101 Tunney's Pasture Driveway
Ottawa, Ontario K1A 0K9

For questions regarding human drugs, please contact Therapeutic Products Directorate at policy_bureau_enquiries@hc-sc.gc.ca

For questions regarding veterinary drugs, please contact Veterinary Drugs Directorate at vetdrugs-medsvet@hc-sc.gc.ca

For questions regarding biologic drugs, and radiopharmaceuticals please contact Biologic and Genetic Therapies Directorate at bgtd_smd_enquiries@hc-sc.gc.ca

Drug Product Information Form - Instructions for Completion

Note: Health Canada reserves the right to request additional documentation.

Application

The Drug Product Information Form (DPIF) is part of the annual DIN renewal.

It is acceptable to cross-reference repetitive sections of the DPIF to the Drug Submission Application Form (HC/SC 3011) where applicable. However, in all cases sections 1 and 2 of the DPIF must be completed.

Section 1 - Drug Product Identification

Manufacturer/Sponsor

• Indicate the full (complete and unabbreviated) name of the manufacturer/sponsor in whose name the drug product DIN and/or DIN/NOC is filed.

Mailing Address, Phone No. and Fax No.  

• Provide the full mailing address of the manufacturer/sponsor. manufacturer/sponsor.
• Provide the telephone and fax numbers for the manufacturer/sponsor.

Drug Product Name   

• Provide the name (complete and unabbreviated) that is assigned by the manufacturer/sponsor to distinguish the drug product and under which the drug product is to be sold and/or advertised. 
• The brand name is the name used to identify the drug product in all correspondence.

Country of Manufacture     

• Provide the name of the country where the final dosage form of the drug product is manufactured/fabricated.

Notice of Compliance   

• Indicate whether the Drug Product has previously been issued a Notice of Compliance (NOC).

Drug Identification Number  

• Enter the 8-digit Drug Identification Number (DIN) assigned by Health Canada to the drug.

Drug Product 

• Indicate whether the Drug Product is a Biological/Radiopharmaceutical; Pharmaceutical; or Drug & Medical Device.

Drug Use:

• Indicate the use of the drug product. If unsure, please leave blank.

Section 2 - Signing Authority

If the signing official is a third party acting on behalf of the manufacturer/sponsor's company, a letter of authorization must be signed by the manufacturer/sponsor and sent with the completed Drug Product Information Form.

Section 3 - Medicinal and Non-Medicinal Ingredients

3.1 Medicinal (Active) Ingredient(s) 

• List the medicinal (active) ingredient(s) present in the final dosage form of the drug product by its/their proper or common name(s).

CAS #

• Indicate the Chemical Abstracts Service (CAS) registry number.  Each and every chemical has a unique number.

Strength, Units

• The strength of the active ingredient(s) should be expressed such as :

3.2 Non-Medicinal Ingredient(s)

• List the non-medicinal ingredient(s) in a manner similar to that for medicinal ingredient(s).

3.3 Animal-/Human-Sourced Material(s) Used at Any Stage in the Manufacture of the Drug Product

• List the Animal-/Human-sourced material(s) used at any stage in the manufacture of the drug.

Section 4 - Animal- and/or Human-Sourced Ingredients/Materials

4.1. Ingredient/Material Name

• List ALL the animal- and/or human-sourced medicinal and non-medicinal ingredients and materials used at any stage in the manufacture of the drug product by their proper or common name.

Complete a separate Section 4 for each individual drug product ingredient and/or material used at any stage in the manufacture of the drug product that was identified as animal- and/or human-sourced in Section 3.

4.2. Used As:

• Indicate whether the animal- and/or human-sourced ingredient/material is used as a: medicinal (active) ingredient, non-medicinal ingredient, or material used at any stage in the manufacture of the drug product.

4.3 Sourced From

Species

• For animals, specify which species in the category indicated. For example, if the animal is a cervidae, specify if it is a moose, a deer, an elk, etc.

Controlled Population

• Specify whether the ingredient is sourced from an animal(s) belonging to an exclusive population reared specifically with the purpose of controlling disease, or reared specifically for use in the pharmaceutical industry (e.g., relevant certification or standards recognition by national, international or third-party).

Biotechnology-Derived Animal

The Health of Animals Regulations under the Health of Animals Act defines biotechnology as "The application of science and engineering to the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms". The term "biotechnology-derived animals" is an extension of the definition of biotechnology. It refers to animals which have been generated through biotechnological methods. For more information, please refer to the Canadian Food Inspection Agency's "Animal Health Risk Analysis Framework for Biotechnology-Derived Animals".

• Specify whether the ingredient is sourced from a biotechnology-derived animal(s).

4.4 Tissues or Fluids of Origin 

• Specify tissues and fluids used to source the ingredients. 

4.5 Age of Animal

• Indicate the age of the animal (in months) at the time the tissue/fluid/macromolecule(s) is sourced.
• It is acceptable to provide a range of ages (in months).

4.6 Country/Countries of origin of animal(s)

• Indicate all countries in which the animal was born and resided.

Appendix 1 - Authorization for a Third Pary to Sign

Questions and Answers

Why is Health Canada doing this?
Recent public health concerns such as Bovine Spongiform Encephalopathy have highlighted the need to ensure that Health Canada has access to the most up-to-date information regarding drug product formulations to manage health risks in public health emergencies, crises or for emerging issues.

How will the information be used?
Health Canada (HC) will maintain an internal database with updated information on drug product ingredients and animal-/human-sourced materials used at any stage in the manufacture of the drug product in case such information is needed to manage health risks (e.g. public health emergencies, crises, emerging issues). The database information will enable HC to identify potential risks to human health, and to request additional information from DIN holders for the conduct of a risk assessment, if and when deemed necessary.

Will it be made publicly accessible?
Health Canada will maintain this information in a database to facilitate easy access of information in the event of a public health emergency. This information will not be publicly accessible. Health Canada intends to maintain this information on therapeutic products while ensuring the confidentiality of all proprietary information. Disclosure of information will only be released in accordance with the Access to Information Act and Privacy Act.

I have already provided this information in my submission package. Do I need to re-submit the information?
All DIN holders and manufacturers of radiopharmaceuticals are requested to submit the Drug Product Information Form. This process will ensure up to-date information for all products, as well as help facilitate the processing of information.

How do I provide the information?
Can I use the sample form included in the mailout?
Please obtain an electronic copy of the Drug Product Information Form (available in Word, WordPerfect, and PDF) on the website and complete the form either electronically or with a typewriter.

Please do not use the sample form.

Send the completed (printed and signed) Drug Product Information Form to the following address:
Submission & Information Policy Division
Therapeutic Products Directorate
Finance Building, AL 0201A1
101 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9

How long do I have to submit this information?
DIN holders should send in the completed (printed and signed) Drug Product Information Form to the above-noted address by August 3rd, 2007.

Does this affect all my products?
All radiopharmaceuticals and products that hold a DIN are affected by this request.

Is this information required for veterinary drug products?
Yes, DIN holders of veterinary drug products should provide Health Canada with a completed Drug Product Information Form.

Will any additional studies be requested of me?
The request to submit the Drug Product Information Form is to help facilitate the creation and population of a searchable database. Any changes to marketed products should follow the appropriate policy and regulatory framework outlined, depending on the type of change made.

Will it affect my ability to market my products?
Submission of the Drug Product Information Form will not affect your ability to market your DIN/radiopharmaceutical product provided that the product continues to comply with safety, efficacy, and quality requirements. Any concerns resulting from the submission of new information will be dealt with on a case-by-case basis.

My product is a Drug/Medical Device Combination. Should I submit information?
If your product holds a DIN, then you are requested to submit the Drug Product Information Form.

I have a radiopharmaceutical. How do I complete the form?
Complete the form as for any other product, but indicate that the DIN is not applicable.

My product is a Natural Health Product. Should I submit information?
All DIN holders and manufacturers of radiopharmaceuticals are requested to submit the Drug Product Information Form. If your product is subject to the Natural Health Products Regulations and has been issued a Natural Product Number (NPN), it is outside the scope of this request, and is therefore not affected.

If the source of my ingredient/material changes occasionally, how should I present this information?
If the change is from a non-animal/human to an animal/human source, indicate this change by completing Section 4 of the Drug Product Information Form, and send the revised section to the above-noted address.

What if I don't know the animal and/or human source(s) of all my ingredients/materials?
The manufacturer/sponsor should have information regarding the composition of ingredients used in drug products. This information is required under Division 2, C.02.009 (Raw Material Testing) of the Food and Drug Regulations. With respect to animal and/or human sources, every effort should be made to identify the source of ingredients in drug products. All DIN holders and manufacturers of radiopharmaceuticals are responsible for the content of the products they market.

I license my product from another manufacturer and do not have the information. What do I do?
In cases where another manufacturer is responsible for the fabrication of a product, the manufacturer may provide Health Canada with the drug product information on behalf of the sponsor. This information must be accompanied by the Third Party Signing Authorization Form included in this package.

I have multiple DINs for the same drug product. Do I need to fill out a form for each DIN?
Yes. Please complete the Drug Product Information Form for each DIN/radiopharmaceutical.

Is there a preferred terminology for non-medicinal ingredients?
Please refer to the Therapeutic Products Directorate document Non-Medicinal Nomenclature for preferred terminology. This document can be located on the website, at http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/nonmedingred/nmi_inm-eng.php

and by navigating the following links:

http://www.hc-sc.gc.ca/dhp-mps/index-eng.php

• English
• Drugs & Health Products
• Drug Products
• Applications & Submissions
• Guidance Documents.

If you need assistance filling out the Drug Product Information Forms (DPIFs), please contact:

Therapeutic Products Directorate, DIN Unit : (613) 941-7977

Veterinary Drugs Directorate : (613) 954-5687 vetdrugs-medsvet@hc-sc.gc.ca

Biologics & Genetic Therapies Directorate : BGTD_RAD_Enquiries@hc-sc.gc.ca