Certificate of Pharmaceutical Products (COPP)

Introduction

The National Health Authorities grant this CoPP certificate upon request from the consumer, the authorities, or the drug supplier in the importing country. This certificate refers to a particular product whether or not it is sold in the country of origin and also states that the manufacturer of the drug complies with GMP and that they are regularly inspected by the national health authorities

A CoPP is issued in the format which is recommended by WHO. It is the importing country which needs the CPP for the pharmaceutical product and a special type of certificate which allows the registration and marketing of a given pharmaceutical product in the exporting country of interest and forms sections of the application for marketing authorization. The CoPP is necessary when the drug is intended by the importing country for registration or renewal (licensing, authorization, or extension) for the scope of the product being sold or marketed in that country. A certificate has been recommended to assist the undersized drug regulatory authorities (DRA) or also without sufficient quality assurance (QA) facilities in WHO importing countries and also to determine the quality of pharmaceutical products according to import or registration requirements.

It is issued by the Inspectorate and the product supplier having GMP position and also the pharmaceutical, radiopharmaceutical, biological or veterinary drug status. The approved information is varied for various pharmaceutical formulations and strengths so it is often provided for a single product.

Objective of certification

A CoPP demonstrates that imported medication is of the relevant standard of quality, safety and efficacy to allow marketing, rigorous testing and inspection in the exporting country to be carried out by regulatory authorities and shows that it meets the relevant standards and procedures of Good Manufacturing Practice (GMP) and improves the product's quality and health.

Drugs for which COPP may be issued

  • Approved drug products
  • Active Pharmaceutical Ingredients (API)
  • Over the counter (OTC) drug product
  • Unapproved product
  • Homeopathic drug

To increase business in a foreign country it is necessary to obtain the COPP certificates by the pharmaceutical company

Who Can Apply

  • The person/company that exports the product must present a complete application for export certification.
  • The qualification is intended for a drug that meets the criteria of the Act or the criteria of the Food Drug and Cosmetic Act.

 

Process of obtaining the certificate

  1. Send Form No. 3613b – Located on the FDA internet www.fda.gov/downloads/AboutFDA/Reports ManualsForms / Forms / UCM052388b) CoPP approval requirements:
  • Applicant Contact Information
  • Trade name (brand name of the drug product) 
  • Bulk Material Generic Name
  •  Applicant's name
  • Product License holder {List of manufacturing site on CPPP}
  •  Full Manufacturing Facility Address
  •  Facility Registration Number
  • Countries importing
  •  Permission to release details
  •  Number of certificates required
  •  Certification Statement
  •  Marketing status in the exporting country
  1. Additional information

Foreign manufactured drugs Export certification from the country for the Foreign Manufacturing sites Approved drug products NDA, ANDA, BLA or approval Letter / Outer Container Label(s) / Package Insert / Package Container (Immediate)

Guideline for COPP form attachments:

  1. All attachments will be required in two sets
  2. Attachments should not be more than 5 pager
  3. Applicant should consult with importing country for different types of information

COPP is generally issued within20 working days from the date of application and issued certificate expires in 2 years from the date of notarization.

Stages to obtain Certificate of Pharmaceutical Products (COPP)

Stage 1

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Stage 4

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