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
Facilitates International Trade: Simplifies export processes for pharmaceutical products.
Regulatory Assurance: Provides importing countries with certified information on product quality, safety, and efficacy.
WHO Compliance: Confirms adherence to WHO Good Manufacturing Practices (GMP).
Process to Obtain Certificate of Pharmaceutical Product in India
Eligibility:
Manufacturer must hold a valid manufacturing license and comply with WHO-GMP standards.
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.
Inspection and Verification:
GMP Inspection: Conducted by the State Authority, often with CDSCO.
Product Review: Evaluates product-specific details.
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
Standardized Format:
COPP follows the WHO-recommended format, widely accepted by regulatory authorities globally.
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