Guidance on Applications for Certificates of Pharmaceutical Product (CPP) – Health Canada Directive

Purpose and Scope

Health Canada provides Certificates of Pharmaceutical Product (CPP) in accordance with the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. The CPP attests to the regulatory status of a drug in Canada, including marketing authorization, manufacturing site compliance with Good Manufacturing Practices (GMP), and any restrictions or conditions. It is primarily intended for regulatory authorities in importing countries to support drug registration or importation. The guidance applies to finished pharmaceutical products (prescription and non-prescription drugs) authorized for sale in Canada. Guidance on Application for Certificate of Pharmaceutical Product (Form 0024) - Canada.ca

Eligibility Requirements

To qualify for a CPP, the product must:

• Hold a valid Drug Identification Number (DIN) or Natural Product Number (NPN) and be authorized for sale in Canada.
• Be manufactured at a site compliant with Canadian GMP requirements (evidenced by a Drug Establishment Licence or GMP certificate).
• Be the subject of an active marketing authorization with no unresolved serious safety concerns or recalls affecting export.
• Not be subject to export restrictions or prohibitions under the Food and Drugs Act.

Applicants must be the marketing authorization holder or an authorized agent with consent.

Application Process

Applications are submitted using the Health Canada Form 0024 (Application for Certificate of Pharmaceutical Product), available on the website. Required information includes:

• Product name, dosage form, strength, and DIN/NPN.
• Manufacturer name and address (including all sites involved in production, packaging, labelling).
• Marketing authorization holder details.
• Intended exporting country and importer (if known).
• Fee payment (current fee schedule applies).

Electronic submission via the Common Electronic Submissions Gateway (CESG) is preferred; paper applications are accepted but may delay processing.

Review and Issuance

Health Canada reviews applications for completeness and compliance:

• Verification of authorization status and GMP compliance.
• Confirmation that no regulatory actions preclude issuance.
• Standard review timeline is approximately 30 calendar days (longer if additional information is requested).

Upon approval, the CPP is issued in the WHO-recommended format, signed by an authorized official, and includes:

• Product details and authorization information.
• Manufacturing site GMP status.
• Date of issue and validity (typically one year).

Refusal or Non-Issuance

A CPP may be refused if:

• The product lacks valid authorization in Canada.
• The manufacturing site is non-compliant with GMP.
• False or misleading information is provided.
• The product is subject to serious unresolved safety issues.
• The application is incomplete or fees are unpaid.

Reasons for refusal are communicated in writing.

Practical Considerations

• Multiple products can be included in one application if they share the same manufacturer and authorization holder.
• Separate CPPs are required for different exporting countries when requested.
• Applicants should maintain current information and notify Health Canada of changes affecting the CPP.
• The certificate does not replace export permits or importing country requirements.

This directive ensures consistent, transparent issuance of CPPs, supporting Canadian drug exporters while upholding regulatory standards. Full application instructions, form links, fee information, and contact details for inquiries are provided in the official guidance document on the Health Canada website. Guidance on Application for Certificate of Pharmaceutical Product (Form 0024) - Canada.ca