Certificate of Pharmaceutical Product (COPP), also known as CPP. Whether you’re a manufacturer looking to expand into new markets or a regulatory affairs professional navigating complex compliance terrain, understanding the COPP is essential.

What is a COPP?

The Certificate of Pharmaceutical Product (COPP) is a standardized document endorsed by the World Health Organization (WHO) under the WHO Certification Scheme. It provides a snapshot of the pharmaceutical product’s quality, safety, efficacy, and regulatory status in the exporting country. The document is primarily used to support the registration of pharmaceutical products in foreign markets, serving as a declaration by the competent authority that the product complies with relevant standards and regulations.

In essence, a COPP confirms:
  • The product is authorized for sale in the exporting country (or is legally exported if not marketed there).
  • It is manufactured in accordance with Good Manufacturing Practices (GMP).
  • The manufacturer is authorized and licensed by the regulatory authority.

Why is the COPP Important?

The COPP plays a central role in Drug Registration and Market Authorization processes in over 80 countries. It enables national regulatory authorities in importing countries to:
  • Validate the approval status of a product in the originating country.
  • Confirm compliance with GMP.
  • Reduce the need for duplicate inspections and testing.
Without a COPP, many national regulatory agencies will not even begin evaluating a drug registration dossier. It’s particularly critical for manufacturers targeting emerging markets where reliance on certifications from agencies like the FDA (U.S.) or EMA (Europe) is a key part of their regulatory review process.

Filing for a COPP in the United States:

In the U.S., COPPs are issued by the Food and Drug Administration (FDA) and managed by the Center for Drug Evaluation and Research (CDER). Here’s how to apply:
  1. Determine Eligibility
    2. The product must either:
    • Be legally marketed in the U.S. (approved under NDA, ANDA, etc.), or
    • Be legally exportable under the Export Reform and Enhancement Act (EREA) even if not approved domestically
  1. Types of COPPs
    2. Depending on the manufacturing and marketing status, the U.S. FDA issues different types of COPPs:
    • Standard COPP (Red ribbon): S.-approved products manufactured and exported from the U.S.
    • Foreign Manufacturer COPP (Yellow ribbon): Product manufactured outside the U.S. but packaged and exported from within the U.S.
    • Non-Marketed COPP (Blue ribbon): Unapproved products legally exportable under U.S. law.
  1. How to Apply
    • Submit Form FDA 3613b electronically through the CDER Export Certification and Tracking System (eCATS).
    • Provide documents such as labeling, package inserts, manufacturing site information, and marketing status.
    • The FDA aims to issue the certificate within 20 government working days, and each COPP is valid for 24 months.
  1. Fees
    • First certificate: $175
    • Second copy: $90
    • Third and subsequent: $40
Note: As of late 2021, the FDA issues COPPs electronically (eCPPs) only.

Filing for a COPP in Europe

In the European Union, COPPs are typically issued by the National Competent Authorities (NCAs) of the member states, not by the European Medicines Agency (EMA) itself. The process varies by country but follows similar WHO guidelines. Key Steps:
  1. Application submission to the respective NCA (e.g., MHRA in the UK, ANSM in France, BfArM in Germany).
  2. Provide details on the product’s marketing authorization in the EU, GMP status, and manufacturing details.
  3. Some countries may require:
    • Translations
    • Certificates of GMP compliance
    • EU marketing authorization reference numbers
The timelines and fees vary by country, and some member states issue COPPs only for products marketed locally.

Why Work with Masuu Global Quality and Regulatory Consultants?

At Masuu Global, we specialize in helping pharmaceutical companies navigate the intricate process of applying for COPPs and ensuring global regulatory compliance. Whether you’re exporting a U.S.-approved drug to Africa, an EU-based biologic to Latin America, or seeking regulatory entry in Southeast Asia, we can:
  • Assess product eligibility and documentation
  • Liaise with regulatory bodies (FDA, EMA, NCAs)
  • Prepare and review COPP application packages
  • Guide your compliance with GMP, labeling, and WHO standards
  • Help you understand local market requirements
Exporting your product without proper certification could lead to regulatory delays, shipment blocks, or financial penalties. Don’t let paperwork stall your global expansion.
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