Certificate of Pharmaceutical Product (COPP)

Certificate of Pharmaceutical Product (COPP)

The Certificate of Pharmaceutical Product (COPP) is issued under the WHO Certification Scheme, certifying that a specific pharmaceutical product is authorized for sale in its country of origin.

Purpose and Importance

1. Facilitates International Trade: Simplifies export processes for pharmaceutical products.
2. Regulatory Assurance: Provides importing countries with certified information on product quality, safety, and efficacy.
3. WHO Compliance: Confirms adherence to WHO Good Manufacturing Practices (GMP).

Process to Obtain COPP in India

1. Eligibility:

   • Manufacturer must hold a valid manufacturing license and comply with WHO-GMP standards.

2. Application Procedure:

   • Document Preparation:
     • Application form, manufacturing license copies, site master file, product summary sheet, and GMP certificate.
     • Submission: Apply through the State Drug Control Department.

3. Inspection and Verification:

   • GMP Inspection: Conducted by the State Authority, often with CDSCO.
   • Product Review: Evaluates product-specific details.

4. Issuance:

   • Upon successful inspection, the State Authority forwards the application to CDSCO, which issues the COPP (valid for two years).

Key Considerations

• Timelines: Prompt documentation aids faster processing.
• Renewal: Renewal applications must be filed before expiration.
• Compliance: Continuous GMP adherence is essential to maintain COPP validity.

Key Features of COPP

1. Standardized Format:

   • COPP follows the WHO-recommended format, widely accepted by regulatory authorities globally.

2. Included Information:

   • Product name and dosage form
   • Active ingredients and strengths
   • Manufacturer’s name
   • Licensing and regulatory status in the exporting country
   • GMP compliance status

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