Guidance Document on the Application for Certificate of a Pharmaceutical Product (GUIDE-0024)

Contact Information and Complete Document for Printing

Table of contents

• 1.0 Purpose
• 2.0 Background
• 3.0 Scope
• 4.0 Definitions
• 5.0 Procedure
  • 5.1 Requirements for issuance of a CPP
  • 5.2 Refusal of issuance of a CPP
  • 5.3 Application Process
  • 5.4 Issuance of a CPP
• 6.0 Effective Date
• 7.0 Reference Documents
• Appendix 1
  Application Form Certificate of a Pharmaceutical Product
• Appendix 2
  Instructions on how to fill out an application for the request of a Certificate of a Pharmaceutical Product
• Appendix 3
  Fee Form Certificate of a Pharmaceutical Product
• Appendix 4
  Request for Stamping Form

1.0 Purpose

This document clarifies the requirements to be met for the issuance of a Certificate of a Pharmaceutical Product (CPP) and describes the procedure for the request of a CPP.

2.0 Background

In 1967, the Twentieth World Health Assembly requested in resolution WHA20.34 that a draft text be prepared on good manufacturing practices (GMP). The text was subsequently submitted to the Twenty-first World Health Assembly in 1968, under the title "Draft requirements for good manufacturing practice in the manufacture and quality control of drugs and pharmaceutical specialities". In 1969, the Twenty-second World Health Assembly endorsed these requirements for "Good Practices in the Manufacture and Quality Control of Drugs" (resolution WHA22.50). These requirements have since been revised: the first revision was adopted by the World Health Assembly in 1975 (resolution WHA28.65) and the most recent revision is included in the Thirty-seventh report of the World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Products.

These requirements also provide the basis for the WHO Certification Scheme on the Quality of the Pharmaceutical Products moving in International Commerce, recommended initially in resolution WHA22.50. The WHO Certification Scheme, an international voluntary agreement, enables countries with limited drug regulatory capacity to obtain partial assurance from exporting countries that the pharmaceutical products, which they plan to import, are safe, effective and of good quality.

All Member States of the WHO are urged to adopt and to apply these GMP standards as recommended by WHO. Canada, represented by the Health Products and Food Branch Inspectorate (HPFB Inspectorate), adopted the WHO Certification Scheme on May 1, 1996. Prior to this date, Certificates of Free Sales were used to attest that the pharmaceutical products were fabricated in compliance with GMPs. These types of certificates are no longer issued. They have been replaced by Certificates of Pharmaceutical Product (CPP) and are issued as a service to the industry when required by an importing country.

3.0 Scope

A CPP is issued for human drugs (pharmaceutical, biological and radiopharmaceutical) as well as for veterinary drugs (food producing animals and non food producing animals). Since the Food and Drugs Act and Regulations apply also to veterinary pharmaceuticals intended for non food producing animals, they must be fabricated according to GMP requirements and consequently, Health Canada chooses to issue CPPs for these pharmaceutical products.

Products falling under the Natural Health Products (NHP) framework are excluded from the scope of this document. Until December 31, 2006, a CPP will be issued to products falling under the NHP framework if the following conditions are met:

• The product license holder and the fabricator listed on the CPP currently hold a valid Site License as per the Natural Health Products Regulations.
• The fabricator listed on the CPP may not currently hold an Establishment License due to the change in regulations, however did hold an Establishment Licence in the 2005 calendar year.
• An inspector from the Health Products and Food Branch Inspectorate conducted a drug GMP inspection at the site listed on the CPP within the last 3 calendar years and the inspection was found to be compliant to drug GMP standards as set out in the Food and Drug Regulations. Under the Food and Drug Regulations, the Health Products and Food Branch Inspectorate considers an inspection to be valid for up to 3 years.
• The product listed on the attached CPP has a valid Canadian Drug Identification Number (DIN), Canadian Natural Product Number (NPN) or Drug Identification Number for Homeopathic Medicines (DIN-HM).

4.0 Definitions / Acronyms

Certificate of a Pharmaceutical Product (CPP): A certificate issued by the Inspectorate establishing the status of the pharmaceutical, biological, radiopharmaceutical or veterinary product listed and the GMP status of the fabricator of the product. This certificate is in the format recommended by the WHO. Certificat de produit pharmaceutique (CPP)

DEL: Drug establishment licence. Licence d'établissement pour les drogues (LED)

Drug: Any substance or mixture of substances manufactured, sold or represented for use in:

1. the diagnosis, treatment, mitigation or prevention of disease, disorder, abnormal physical state, or its symptoms, in human beings or animals;
2. restoring, correcting or modifying organic functions in human beings or animals, or
3. disinfection in premises in which food is manufactured, prepared or kept. Drogue

Drug Identification Number (DIN): An eight (8) digit numerical code assigned to each drug product marketed under or in accordance with the FDA. Drogue: identification numérique (DIN)

FDA: Food and Drugs Act. Loi sur les aliments et drogues

FDR: Food and Drug Regulations. Règlement sur les aliments et drogues

GMP: Good Manufacturing Practices. Bonnes pratiques de fabrication (BPF)

GP: General Public. Grand public

HPFBI: Health Products and Food Branch Inspectorate. Inspectorat de la Direction générale des produits de santé et des aliments (IDGPSA)

INNS: International nonproprietary names. Dénominations communes internationales (DCI)

NHP: Natural Health Product. Produit de santé naturel (PSN)

Section 37 of the FDA: Section 37 exempts certain drugs from the application of the FDA:

37. (1) "This Act does not apply to any packaged food, drug, cosmetic or device, not manufactured for consumption in Canada and not sold for consumption in Canada, if the package is marked in distinct overprinting with the word "Export" or "Exportation"and a certificate that the package and its contents do not contravene any known requirement of the law of the country to which it is or is about to be consigned has been issued in respect of the package and its contents in prescribed form and manner."

Articles 37 de la Loi sur les aliments et drogues

WHO: World Health Organization. Organisation mondiale de la Santé (OMS)

5.0 Procedure

A CPP, in the format recommended by the WHO, establishes the status of the pharmaceutical product listed on the certificate, and the GMP status of the fabricator of the pharmaceutical product, in the exporting country. The HPFB Inspectorate issues a CPP to one of the following applicants:

• the Drug Identification Number (DIN) owner of the pharmaceutical product; or in the case of radiopharmaceuticals the party to which an NOC has been issued
• the fabricator of the pharmaceutical product; or
• a third party that submits, along with the application, a written authorization for the issuance of the CPP from the DIN owner of the pharmaceutical product.

5.1 Requirements for issuance of a CPP

5.1.1 When the pharmaceutical product is fabricated and packaged/labelled in Canada, a CPP is issued if all the following requirements are met:

• the fabricator and packager/labeller are GMP compliant;
• the pharmaceutical product has a valid DIN and a valid date of notification;
• or in the case of radiopharmaceuticals an NOC has been issued and the product has a valid date of notification*
• the pharmaceutical product is sold on the Canadian market;

*Please note: the application form requests the "date of notification" and this is inserted in the field, on the certificate, identified as the date of issue. The date of notification indicates the date of issuance of the product on the market.

5.1.2 When the pharmaceutical product is fabricated in a foreign country and packaged/ labelled in Canada or fabricated in Canada and packaged/ labelled in a foreign country, a CPP is issued if all the following requirements are met:

• the packager/labeller and the fabricator are GMP compliant;
• the foreign establishment is GMP compliant and is listed on the Canadian Drug Establishment Licence (DEL);
• the pharmaceutical product has a valid DIN or an NOC and a valid date of notification;
• the pharmaceutical product is sold on the Canadian market;

5.1.3 When the pharmaceutical product is fabricated and/or packaged/labelled in Canada but not marketed in Canada, a CPP is issued if the following conditions are met:

• the fabricator and/or packager/labeller are/is GMP compliant;
• a DIN or an NOC has been issued, (that is the drug product has market authorization).

5.1.4 When the pharmaceutical product is fabricated in Canada and not sold on the Canadian market, but the drug submission is under review, a CPP is issued if the fabricator is GMP compliant and if the applicant submits information on the formulation and active ingredients of the pharmaceutical product. Furthermore, the CPP issued will carry the following statement: "The product is manufactured for export only. The Health Products and Food Branch of Health Canada is currently reviewing an application to permit the marketing of this product in Canada."

5.1.5 If the request for a CPP is not specific for a pharmaceutical product, a certificate is issued when the fabricator is GMP compliant. In this particular case, the modified certificate that is issued indicates the dosage form only, instead of the product information.

5.2 Refusal of issuance of a CPP

5.2.1 When the pharmaceutical product is fabricated and/or packaged/labelled in a foreign country, no CPP is issued if the foreign establishment is not GMP compliant and/or is not listed on the Canadian Drug Establishment Licence (DEL).

5.2.2 When the pharmaceutical product is fabricated in a foreign country and imported into Canada solely for the purpose of providing a contract packaging/labelling service to the foreign site that retains ownership of the pharmaceutical product, no CPP is issued.

5.2.3 A CPP will also not be issued for the following reasons, including the application is incomplete, the application is received by e-mail and/or Section 37 of the FDA has been invoked.

5.3 Application Process

5.3.1 The applicant must fill out the "Application Form for a Certificate of a Pharmaceutical Product", which is included in this document as Appendix 1 or is available on the Health Canada's Compliance and Enforcement website at the following address:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/index-eng.php. Instructions on how to fill out this form are included in this document as Appendix 2.

5.3.2 If the application is specific for a pharmaceutical product, one application form must be filled out per product, since manufacturing arrangements and approved information for different strengths can vary. Furthermore, one application must be filled out per country of consignment.

5.3.3 The applicant must fill out the "Fee Form for a Certificate of a Pharmaceutical Product", which is included in this document as Appendix 3 or is available on the Health Canada's Compliance and Enforcement website at the following address: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/index-eng.php.

5.3.4 The fee for each certificate is $50.00 plus tax:

• Applications originating from Quebec ($50.00 + 6% GST + 7.5% PST = $56.98),
• Applications originating from New Brunswick, Nova Scotia and Newfoundland ($50.00 + 14% HST = $57.00),
• Applications originating from other provinces ($50.00 + 6% GST = $53.00).

5.3.5 For supplemental copies of the same certificate (i.e. same product and same DIN), the request must be submitted at the same time as the request for the original CPP. The fee for each supplemental copy is $25.00 plus tax:

• Applications originating from Quebec ($25.00 +6% GST + 7.5% PST = $28.49),
• Applications originating from New Brunswick, Nova Scotia and Newfoundland ($25.00 + 14% HST = $28.50),
• Applications originating from other provinces ($25.00 +6% GST = $26.50).

5.3.6 One fee form copy must be submitted with each group of certificate applications.

5.3.7 A payment must accompany the application forms and the fee form. Payment may be made by:

• a cheque or money order for the total amount due, made payable to the Receiver General for Canada,
• company account
• Visa,
• MasterCard,
• Amex Card.

5.3.8 Payment should be in Canadian funds. Non-payment, partial payment or payment in non-Canadian funds, will result in return of the application at the company's expense. However, if US dollars are used, the exchange rate should be applied to ensure that full payment is made. Any overpayment will be credited against the firm's account. Any payment being charged to a compaany account must be accompanied by the appropriate account number.

5.3.9 If documents relating to the product indicated on the certificate need to be stamped by Health Canada, the applicant must:

• fill out the "Request For Stamping Form", which is included in this document as Appendix 4 or is available on the Health Canada's Compliance and Enforcement website at the following address: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/form/index-eng.php,
• have the form sworn before a Notary Public, and
• submit the form with TWO copies of the information to be stamped. One copy is stamped and returned to the applicant and the other copy is retained in Health Canada files.

5.3.10 The application form, the fee form, the payment and the request for stamping form, along with the documents to be stamped, must be sent to:

Health Products and Food Branch Inspectorate
Establishment Licence Unit
Graham Spry Building, 2^nd Floor
250 Lanark Avenue
Address Locator # 2002A
Ottawa, Ontario
K1A 0K9

5.3.11 In order to expedite certificate issuance, the applicant should include a completed shipping form (waybill Purolator, Fedex, Loomis, UPS, Dicom, etc....) with each request.

5.3.12 For questions related to CPPs, please contact the HPFB Inspectorate (same address as above):

Telephone: 613-957-1166

5.3.13 For questions related to fees, please contact the Cost Recovery Office:

Financial Management and Advisory Services
Holland Cross - Tower A
11 Holland Avenue, 5^th Floor
Address Locator: # 3002B
Ottawa (Ontario) K1A 0K9

Telephone: 613-946-0496 or 1-800-815-0506
Facsimile: 613-957-3495

5.4 Issuance of a CPP

5.4.1 The HPFB Inspectorate has a target for issuance of CPPs within 5 business days.

5.4.2 A seal is affixed on each page of the certificate. Each seal is individually numbered in a sequential order and indicates in large fonts the year of issuance. Furthermore, a fluorescent watermark is incorporated as an additional security feature.

5.4.3 A CPP is valid for a period of 1 year from the date of the issuance of the CPP.

5.4.4 If a certificate is not issued because one of the above mentioned requirements is not met, the HPFB Inspectorate will inform the applicant and the fees will not be refunded. The applicant must reapply for the CPP. Please note that if a certificate is issued and it contains an error for which the HPFB Inspectorate is responsible, the HPFB Inspectorate will issue a new certificate, upon request, free of charge. The replacement certificate will be issued with the original date of issue unless otherwise requested.

6.0 Effective date

This document will become effective April 1, 2006.

7.0 Reference documents

Conditions for Acceptance of Foreign Inspection Reports for Listing Foreign Sites on Canadian Establishment Licences

Guidance document on the commercial importation and exportation of drugs in dosage forms under the Food and Drugs Act

Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce

Appendix 1

Application Form
Certificate of a Pharmaceutical Product

This is a request for a Certificate of a Pharmaceutical Product (CPP) in the format recommended by the World Health Organization (WHO).
(one form must be completed for each product and country)

i) Country of Consignment:

ii) Brand name:

iii) Proper name:

Potency:

iv) Dosage Form:

v) DIN:

• This is a veterinary pharmaceutical intended for use in a non-food producing animal^{Footnote 1}
• Date of notification:
• I certify that this product is currently on the Canadian market
• This product is not on the Canadian market for the following reason(s):

vi)

• I certify that the above mentioned product has been fabricated in accordance with the currently approved master production document.

vii) Manufacturer's/sponsor's name:

Canadian address:

viii) Site(s) (name and address) of the production of this product:

ix)

• I certify that the above mentioned product is fabricated in compliance with the Canadian Good Manufacturing Practices (GMP) provisions.

x)

• If the above-mentioned product is fabricated at a foreign site; I certify that I have evidence it complies with Canadian Good Manufacturing Practices (GMP) provisions and the foreign site appears on my Drug Establishment Licence (DEL).
• Date of most recent inspection:
• DEL #:
  Expiration date on DEL:
  Date of most recent inspection:

xi)

• I certify that the manufacturer as identified in (vii), will advise the Health Products and Food Branch Inspectorate (HPFB Inspectorate) of any quality defects or other hazard associated with the product or shipment that may be determined.

xii)

• The certificate must be returned by prepaid courier. The certificate may be returned by regular mail.

xiii)

• English certificate French certificate

Name

Telephone ( )

Title

Facsimile ( )

Company

Signature

Date

Appendix 2

Instructions on how to fill out an application for the request of a Certificate of a Pharmaceutical Product

The following information and declarative statements must be provided by the applicant when requesting a CPP. Clarification regarding the sections of the Application Form is provided below:

i) Country of consignment: The importing country (e.g. Nigeria, Thailand)

ii) Brand name: The trade name appearing on the product label

iii) Proper name and potency declaration: International nonproprietary names (INNS) or national nonproprietary names should be used.

iv) Dosage form: Describe the dosage form in detail (e.g. film coated tablet, pressurized aerosol spray).

v) DIN: Provide the number and the date of notification. Indicate if the product is currently marketed in Canada and if not, provide a statement as to the reason. The date of notification is the date the product was issued onto the market.

Check the box if the product is a veterinary pharmaceutical intended for use in non-food producing animals.

vi) Check this box to certify that the product in question has been fabricated in accordance with the currently approved master production document. Failure to so certify may result in rejection of the application.

vii) Manufacturer's/sponsor's name and Canadian address: As specified

viii) Site(s) (name and address) of production of this product: It must be completely clear as to the site(s) of fabricating and packaging. This information allows the HPFB Inspectorate to make statements about the GMP compliance status of third parties. The names and addresses of third parties will be included on the certificate unless you request that this information remain confidential. A CPP for a drug fabricated outside of Canada will refer to the most recent evaluation of the foreign site(s). If the applicant is a person other than the legal agent, authorization for issuance of the certificate is required from the DIN owner of the pharmaceutical product.

ix) Check this box to certify that the product in question is fabricated in compliance with Canadian GMP provisions (Division 2, Part C, Food and Drug Regulations). The date of the last inspection must be indicated

x) If the product is fabricated in a foreign site, check this box to certify that you have evidence the product in question is fabricated in compliance with Canadian GMP provisions (Division 2, Part C, Food and Drug Regulations). The expiration date assigned to the foreign site must correspond with what appears on your current DEL. Please ensure your DEL lists all foreign fabricators. The date of the last inspection must also be indicated.

xi) Check this box to certify that the fabricator will advise the HPFB Inspectorate of any quality defects or other hazard associated with the product or shipment that may be determined. The DIN owner and/or the fabricator are also responsible for notifying the HPFB Inspectorate if the product is recalled.

xii) Check the appropriate box to indicate how the certificate should be shipped. If the certificate is to be returned by courier, please provide the name of your courier and your account number on the Certificate of a Pharmaceutical Product Fee Form.

xiii) Indicate which Official Language the certificate will be issued in: English or French.The name, signature, phone number, etc. of the applicant must also be provided.

Appendix 3

Fee Form
Certificate of a Pharmaceutical Product

To: Establishment Licensing Unit
Health Products and Food Branch Inspectorate
Graham Spry Building, 2^nd Floor
250 Lanark Avenue
Address Locator # 2002A
Ottawa , Ontario
K1A 0K9

Re: Application for a Certificate of a Pharmaceutical Product

Please find enclosed, applications for # certificates.

• Fee calculation: number of certificatesx $53.00 ($50.00 + 6% GST) =
• Fee calculation: number of supplementary certificatesx $26.50 ($25.00 + 6% GST) =
• Fee calculation (requests originating from Québec) :
  number of certificatesx $56.98 ($50.00 + 6% GST + 7.5% PST) =
• Fee calculation: number of supplementary certificates (requests originating from Québec) :
  x $28.49 ($25.00 + 6% GST + 7.5% PST) =
• Fee calculation (requests originating from New Brunswick, Newfoundland, Nova Scotia):
  number of certificates $$57.00 ($50.00 + 14% HST) =
• Fee calculation: number of supplementary certificates (requests originating from New Brunswick, Newfoundland, Nova Scotia):x $28.50 ($25.00 + 14% HST) =

PAYMENTS

• Prepayment
• Cheque
  • (A cheque or money order in the amount of $ made payable to the Receiver General for Canada, is enclosed with this application).
• Credit Card
  • Visa / MasterCard / AMEX
  • Card # + (for MasterCard 4 digit # above cardholder's name)
  • Valid Date: Expiry Date: Amount: $

Name and Telephone number of contact person:

Return of issued certificates by collect courier is hereby authorized:

Name of Courier:

Signature of applicant:

Name (printed):

Company name:

Address:

Phone number:

Date:

Account Number:

Title:

Facsimile:

Appendix 4

Request for Stamping Form

(Submit this form with TWO COPIES of any material that is to be stamped. One copy of the material will be stamped and returned to you with your Certificates. The other copy will be retained in Health Canada files.)

The undersigned Company requests that Health Canada stamp and return one copy of the enclosed information for attachment to a Certificate of Pharmaceutical Product.

Product name:

Summary of attached information and material:

We certify that the attached information and material are accurate and up-to-date and that copies of this information and material are on file with Health Canada.

• Name of Company
• Name of Company Representative
• Signature of Company Representative
• Title of Company Representative
• Date

THIS DOCUMENT MUST BE SWORN BEFORE A NOTARY PUBLIC.

• Name
• (Seal)
• Signature
• Date

This form is subject to HPFB Inspectorate revision. May 2000