Certificate of Pharmaceutical Product (COPP) is a regulatory document issued by a competent National Regulatory Authority (NRA) that certifies a medicinal product’s marketing authorization, approved manufacturer, dosage form, strength, shelf-life and often compliance with Good Manufacturing Practice (GMP). For B.Pharm students, understanding COPP procedure and significance is essential for export, drug registration, quality assurance and international regulatory affairs. Key topics include WHO Certification Scheme, application steps, required annexes (Free Sale Certificate, GMP certificate), legalization/apostille, electronic COPP trends, and implications for reliance-based approvals. Mastery of COPP helps future pharmacists navigate global supply chains and regulatory submissions. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary purpose of a Certificate of Pharmaceutical Product (COPP)?
- Confirms product sales data in the importing country
- Certifies manufacturing equipment specifications
- Certifies product authorization and GMP compliance for export
- Replaces the need for product registration in all countries
Correct Answer: Certifies product authorization and GMP compliance for export
Q2. Which authority normally issues the COPP?
- World Health Organization (WHO)
- National Regulatory Authority or competent authority of the exporting country
- Manufacturer’s quality assurance head
- Importer’s regulatory representative
Correct Answer: National Regulatory Authority or competent authority of the exporting country
Q3. The COPP format and guidance are recommended under which international scheme?
- International Council for Harmonisation (ICH)
- World Health Organization (WHO) Certification Scheme for Pharmaceutical Products
- United States FDA guidance
- European Medicines Agency (EMA) dossier scheme
Correct Answer: World Health Organization (WHO) Certification Scheme for Pharmaceutical Products
Q4. Which of the following is NOT typically included in a COPP?
- Product name, strength and dosage form
- Marketing authorization number and holder
- Batch number of a specific manufactured batch
- Date of issue and issuing authority signature
Correct Answer: Batch number of a specific manufactured batch
Q5. For an importing regulatory authority, the COPP is primarily used to:
- Replace all local quality testing requirements
- Facilitate registration and demonstrate product status in the exporting country
- Provide final batch release data for imported lots
- Authorize clinical trials in the importing country
Correct Answer: Facilitate registration and demonstrate product status in the exporting country
Q6. Who typically signs and issues the COPP within the issuing authority?
- Manufacturer’s Production Manager
- Licensing, registration or certification officer at the NRA
- Chief Executive Officer of the importing company
- Clinical trial principal investigator
Correct Answer: Licensing, registration or certification officer at the NRA
Q7. Is there a universal, globally fixed validity period for all COPPs?
- Yes — 12 months for all countries
- Yes — 36 months for all countries
- No — validity depends on the importing country and its requirements
- Yes — lifetime validity once issued
Correct Answer: No — validity depends on the importing country and its requirements
Q8. Does a COPP itself guarantee the complete product quality for every batch?
- Yes — it guarantees full quality for every batch
- No — it indicates regulatory status and GMP compliance but does not replace batch testing
- Yes — only for biologic products
- Only if issued with a Certificate of Analysis
Correct Answer: No — it indicates regulatory status and GMP compliance but does not replace batch testing
Q9. When is legalization or apostille of a COPP commonly required?
- Always, regardless of importing country
- Never — COPP is always accepted as-is
- When the importing country requires additional authentication such as apostille or embassy legalization
- Only when the product is a controlled substance
Correct Answer: When the importing country requires additional authentication such as apostille or embassy legalization
Q10. What is the current trend regarding electronic COPP (e-COPP)?
- Not accepted by any regulatory authority
- Increasingly accepted by many regulators alongside or instead of paper COPP
- Only accepted for investigational products
- Only used within WHO prequalification program
Correct Answer: Increasingly accepted by many regulators alongside or instead of paper COPP
Q11. How does a COPP differ from a GMP certificate?
- They are identical documents
- COPP concerns product authorization and marketing; GMP certificate certifies the manufacturing site’s compliance
- COPP certifies raw material suppliers; GMP certifies distributors
- COPP is only for biologics; GMP is only for small molecules
Correct Answer: COPP concerns product authorization and marketing; GMP certificate certifies the manufacturing site’s compliance
Q12. Which document commonly accompanies a COPP to support export and registration?
- Free Sale Certificate (FSC)
- Batch sample vial without documentation
- Clinical trial approval letter
- Environmental impact report
Correct Answer: Free Sale Certificate (FSC)
Q13. Who holds the primary responsibility for the factual accuracy of information stated in the COPP?
- The importer
- The issuing National Regulatory Authority (NRA)
- The foreign marketing authorization holder only
- World Health Organization (WHO)
Correct Answer: The issuing National Regulatory Authority (NRA)
Q14. Does a COPP typically include a statement that the product is authorized for sale in the exporting country?
- Yes — it includes a statement about authorization for sale
- No — it only lists manufacturing sites
- Only if the product is a vaccine
- Only for products under emergency use
Correct Answer: Yes — it includes a statement about authorization for sale
Q15. Can a COPP be issued for products that are not licensed or authorized in the exporting country?
- Yes — for investigational products broadly
- No — COPP is issued only for products authorized in the exporting country
- Yes — but only for generic medicines
- Yes — for any product manufactured in the country
Correct Answer: No — COPP is issued only for products authorized in the exporting country
Q16. Can COPP support reliance-based regulatory approvals in importing countries?
- No — it is never used for reliance
- Yes — importing regulators may rely on COPP and issuing NRA information as part of a reliance pathway
- Only if WHO directly endorses the product
- Only for controlled substances
Correct Answer: Yes — importing regulators may rely on COPP and issuing NRA information as part of a reliance pathway
Q17. A COPP is normally issued for a product that is in which market status?
- Officially authorized and marketed in the issuing country
- Currently under clinical trial only
- Suspended or banned products
- Products with revoked marketing authorization
Correct Answer: Officially authorized and marketed in the issuing country
Q18. Which authentication approach is applicable for COPP between countries that are parties to the Hague Apostille Convention?
- Embassy legalization only
- Apostille is commonly accepted for document authentication
- No authentication is ever required
- Certification by WHO regional office
Correct Answer: Apostille is commonly accepted for document authentication
Q19. If the manufacturing site for a registered product changes, what typically must happen to the COPP?
- The old COPP remains valid indefinitely
- A new or updated COPP must be issued reflecting the site change
- No documentation is required for site changes
- The COPP is simply annotated by the manufacturer without NRA involvement
Correct Answer: A new or updated COPP must be issued reflecting the site change
Q20. Does a COPP include a statement about GMP compliance of the manufacturing site?
- True — it may include a statement or reference to GMP compliance
- False — COPP never refers to GMP
- True — but only for sterile injectables
- False — GMP is only covered in separate WHO reports
Correct Answer: True — it may include a statement or reference to GMP compliance
Q21. In India, which central authority is typically responsible for issuing COPPs?
- State Drug Controller
- Central Drugs Standard Control Organization (CDSCO)
- Indian Council of Medical Research (ICMR)
- Pharmacy Council of India
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q22. Which international guideline specifically describes the concept and format of COPP?
- ICH Q7 Good Manufacturing Practice
- WHO Certification Scheme for Pharmaceutical Products
- USP compendial monographs
- FDA Orange Book guidance
Correct Answer: WHO Certification Scheme for Pharmaceutical Products
Q23. Which of the following is NOT a primary purpose of the COPP?
- To facilitate export and international registration
- To demonstrate GMP compliance and marketing authorization status
- To provide exhaustive batch-specific analytical results for each lot
- To support regulatory reliance and import decisions
Correct Answer: To provide exhaustive batch-specific analytical results for each lot
Q24. What is commonly required to confirm the authenticity of a paper COPP?
- Original stamped and signed copy from the issuing authority
- Unsigned photocopy from the manufacturer
- Faxed copy without seal
- Email text from a third party
Correct Answer: Original stamped and signed copy from the issuing authority
Q25. Can COPP be issued for over-the-counter (OTC) medicines?
- Yes — COPP can be issued for OTC medicines that are authorized and marketed
- No — COPP is only for prescription medicines
- Only for veterinary OTC products
- Only if the product contains controlled substances
Correct Answer: Yes — COPP can be issued for OTC medicines that are authorized and marketed
Q26. Does a COPP typically include details of dosage form and strength of the product?
- Yes — dosage form and strength are included
- No — it omits formulation details
- Only strength is included, not dosage form
- Only qualitative description without strength
Correct Answer: Yes — dosage form and strength are included
Q27. For a generic product seeking registration abroad, how does a COPP assist the importer or regulator?
- By demonstrating the product is authorized in the exporting country and indicating GMP compliance
- By serving as a full replacement for local bioequivalence studies
- By providing full manufacturing batch records
- By guaranteeing lower pricing for procurement
Correct Answer: By demonstrating the product is authorized in the exporting country and indicating GMP compliance
Q28. Issuance of a COPP normally requires submission of which primary document or evidence?
- Marketing authorization dossier or proof of product registration in the exporting country
- Random sample of the finished product
- A copy of clinical trial case report forms
- List of distributors in the importing country
Correct Answer: Marketing authorization dossier or proof of product registration in the exporting country
Q29. Which party usually maintains an official record of COPP issuance?
- The World Health Organization central archive
- The issuing National Regulatory Authority (NRA)
- The importer’s regulatory affairs department
- The courier company that shipped the COPP
Correct Answer: The issuing National Regulatory Authority (NRA)
Q30. Does a COPP typically contain information about product shelf-life and recommended storage conditions as per the authorization?
- Yes — it usually includes shelf-life and storage conditions
- No — such stability information is never included
- Only if requested by the importer
- Only for biologics and temperature-sensitive products
Correct Answer: Yes — it usually includes shelf-life and storage conditions
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com