INTRODUCTION:

This CoPP certificate is issued by the National Health Authorities upon request from the customer, the authorities or the manufacturer of product in the importing country. This certificate is for a specific product whether the it is marketed in the country of origin or not and also states that the product’s manufacturer complies with GMP and whether they are inspected regularly by the national health authorities[1, 7]

A CoPP is in the format recommended by the WHO. It is the importing country who requires the CPP for the pharmaceutical product and a special type of certificate which enables a given pharmaceutical product to be registered and marketed in the exporting country of interest and forms parts of the marketing authorization application. [1]

This is issued by the Inspectorate and the fabricator of the product having GMP position and also the position of the pharmaceutical, radiopharmaceutical, biological, or veterinary product. [2]

The approved information for different pharmaceutical forms and strengths is varied so it is always issued for a single product. [1]

Received on 12.08.2015 Modified on 21.08.2015

Research J. Pharm. and Tech. 8(10): Oct., 2015; Page 1449-1453

DOI: 10.5958/0974-360X.2015.00260.7

Aim:

A CoPP demonstrates in question that the imported medicine is of the appropriate standard of quality, safety and efficacy to allow marketing in their market, having undergone rigorous testing and examination to Regulatory Authorities in the exporting country and also demonstrates that it follows the correct guidelines and procedures of Good Manufacturing Practice (GMP), increasing the level of quality and indeed safety of the product. [2,7]

SCOPE:

The CoPP is needed when the product tends that it is intended for registration or its renewal (licensing, authorization or prolongation)) by the importing country, with the scope that the product are distributed or commercialized in that country.

A Certificate has been recommended so that it helps the undersized drug regulatory authorities (DRA) or also without proper quality assurance (QA) facilities in importing countries by WHO and also it can assess the pharmaceutical products quality as per prerequisite of importation or registration.

A CoPP, which recommends WHO to national authorities for its esurient that confirmed method is analytical by the national laboratory, to view and also necessary to adapt information of product as per labelling requirements also bioequivalence and also some stability data. Regulatory practices vary in importing countries.

Also, dossiers assessment needed, with different levels and requirements complexity to satisfy quality assurance of drugs.

Inspection:

The DRA gives a CoPP only after conducting an inspection of the manufacturing product. (The Pharmaceutical market of India is estimated at around Rs65, 000 crore. Out of which, accounts of export for around Rs30, 000 crore.)[1, 2]

Types of CoPP :

1) WHO 1975 type CoPP

The WHO 1975 version is a certificate to be issued by exporting country regulatory authority stating:

a) the authorized product has to be placed on the market for its use in the country also, the permit number and issue date, or

b) that the nonauthorized product has placed on the market for its use in the country and also add the reasons why it is needed;

Also, that;

a) As recommended by World Health Organization, the manufacturer of product conforms to GMP requirements.

b) only within the country of origin the products to be sold or distributed ;or

c) To be exported to manufacturing plant where the product is produced and at suitable intervals subject to inspections.

2) WHO 1988 type CoPP

Unlike the WHO 1975 version, the competent authority of the exporting country should have:

● All labelling copies.

● Product detailed information in the country of origin (see annex 3).

3) WHO 1992 type CoPP

This is intended for use by the competent authority of an importing country in two situations:

a) When the question arises related to importation and sale license; and

b) For license renew, extend, review or changes.

The following information required for the certificate:

i) Whether a licensed product is required to be placed on the market or not.

ii) Also if the satisfied information submitted by the applicant that the certifying authority of the manufacture of the product undertaken by another party

iii) Inspection have been carried out of the manufacturer of product;

iv) If the certificate is provisional or permanent;

v) Is the dosage forms, packages and/or labels of a finished dosage form manufactured by an independent company or by the applicant;

vi) states the names of the importing and exporting (certifying) countries

Here besides three types of CoPPs also we have another specific type of the U.S. FDA CoPPs: [14]

The U.S. FDA issued “Pilot- CoPP” for the remaining products which are neither exported nor manufactured in the United States. It is only when no other country has given an approval for the finished medicinal product registration.

Certificate of a pharmaceutical product model[1,2,3]

The form is suitable for generation by computer. It should be submitted as hard copy, with responses printed in type rather than handwritten.

Reference Number:

Date:

This certificate conforms the format of WHO.

Certificate no.:

Importing country name:

Exporting country name:

1. Name and its dosage form:

1(a). API(s) and its amount per dose

Also see attached for (complete composition including excipients),

1(b) Is the product placed for use in the exporting country or not?

1(c) If the product present on the market in the exporting country?

● If the answer is yes, continue with section 2 and omit section 3.

● If the answer is no, omit section 2 and continue with section 3.

2.1. Number of product license and date of issue:

2.2. Product license holder (name and address):

2.3. Status of product license holder:

2.3.1. For b and c categories, the name of product and address of its manufacturer must be present:

2.4. if approval appended or not?

2.5. Is the officially approved product information complete and readily available according to the license?

2.6. Applicant for certificate, if different from license holder (name and address):

3. Certificate applicant (name, address and required info):

3.1 Status of applicant:

3.2 For (b) and (c) categories, the name and address of the manufacturer producing the dosage form is:

3.3 if the marketing authorization not required, not requested, under consideration or refused ?

3.4 other additional information

3.5 If the periodic inspection of the manufacturing plant in which the dosage form is produced or not/not applicable?

If not or not applicable, proceed to question 5;

4. Routine inspections periodicity (years):

4.1. Has the manufacture been inspected or not?

4.2 The operations and facilities conform to GMP recommendation or not?

5. The information submitted by the applicant satisfy the certifying authority or not?

Explanation required if not authorized:

Also, information like;

Certifying authority address:

Fax:

Telephone:

Name of authorized person with signature:

Stamp and date:

Proposed Layout of certificate of Pharmaceutical Product(s) present in ANNEX 3 (b): [2, 3,6 ]

● It should be product specific. The approved information for different dosage forms of the API which are same frequently differs in fundamental aspects.

● Confusion will arise if information relating to different products, or even different usage forms, is attached to the same certificate.

Name and dosage form of product:
Name and amount of each active ingredient:
	..........................................................................
Manufacturer, the person responsible for placing the product on the market:
	Address: ..................................................................................
It is certified for:
	The product has been authorized to be placed on the market for use in this country.
	Number of permit and date of issue (if applicable):
	The enclosed documents constitute the complete text of all labelling and prescribing information which is authorized for use in this country.
	This product has not been authorized to be placed on the market for use in this country for the following reasons :

Whenever required please use (INNs) International Nonproprietary names, also national nonproprietary names.

Also:

● The plant in which the product is produced, inspection is required at suitable interval.

● The manufacturer conforms to requirements of GMP in the Organization, with respect to the products to be distributed within the country of origin or can be exported.

Also, Signature of authority who designed, Place and date are also mentioned.

How to obtain CoPP? [2, 8, 11]

● To obtain a CoPP, a request is made to the exporting country’s health authority by the Marketing Authorization Holder (MAH).

● An authorized person issues the CoPP and returns it to the MAH. Also other documents required to obtain a CoPP including an application for Export Certificate form, evidence of a GMP certificate (if applicable), Manufacturing License and the last approved SPC (Summary of Product Characteristics).

Content and format [8, 12]

· Importing country:

· Exporting country:

· Name, form of dosage and its composition of the product (API per unit dose).

· Registration Information (licensing)

· Marketing status of the product in the exporting country.

· license no. of product (containing license holder details; involvement of license holder in manufacturing if any) and also add date of issue,

· Summary of technical basis on which the product has been licensed (if required by the issuing authority)

· Currently marketed product’s information

· Details about the product’s applicant

· If lacking is there in the exporting country, need to mention the information about reasons.

Certificates May Be Issued [5, 12]

· Legally marketable drug in the country.

· Nonauthorized drugs for distribution in the country which are legally exported to a foreign country.

· For a foreign manufactured drug.

Exportation for Personal Use [9]

● Awareness is necessary for the drugs that are legal in some countries may be illegal in other countries.

Importation for Personal Use [9]

● Risky to health, such drugs are prevented from importation.

● Also Enforcement actions have been taken domestically..

Types of drugs for which CoPPs may be issued [5]

● Approved drug products

● Active pharmaceutical ingredients (API)

● Over the counter drug (OTC) products

● Unapproved drug products

● Homeopathic drugs

Who can apply for CPP? [5, 12]

· A complete application for export certification must be submitted by the person/company who exports the drug.

· The certification is intended for a drug which : meets the applicable requirements of the Act or Food Drug and Cosmetic Act 801(e)(1) requirements [21 U.S.C.381(e)(1)]

Process to apply for a CoPP [5, 10, 12]

a)Submit Form no. 3613b– Located on the FDA internet www.fda.gov/downloads/AboutFDA/Reports Manuals Forms/Forms/UCM052388

b) Requirements for CoPP application:

· Applicant Contact Information

· Trade name (the drug product’s brand name)

· Bulk Substance Generic Name

· Name of Applicant

· Status of Product License holder

· Listing of manufacturing location on CPP

· Complete Manufacturing Facility Address

· Facility Registration Number

· Importing countries

· Authorization to Release Information

· Number of certificates requested

· Certification Statement

· Billing contact

· Marketing Status in the Exporting Country

Additional Required Information [5]

Foreign Manufactured Drugs Exportation certification from the country for the Sites of Foreign Manufacturing

Approved Drug Products NDA, ANDA, BLA or Approval Letter

· Outer Container Label(s)

· Package Insert

· Package Container (Immediate)

· Status of Product-license Holder

Unapproved Drug Products Product Identification Statement Formulation page

Over-the-Counter (OTC) Drug products

· Title of the applicable monograph

· Product Label(s)

· Immediate Package Container Label

Active Pharmaceutical Ingredients (API) main sample of the bulk container.

Export only formulation page.

COPPs should be issued as per Model Certificate of Pharmaceutical Product recommended by World Health Organization, given in TRS 86[10] of WHO.

Attachments to CoPP [13]

· Two sets of attachments required for one country (one set to attach to the certificate package and one set for FDA files).

· Attachments must not be more than five pages per certificate.

· Applicant is responsible for consulting with the importing country to determine the type of the information required.

Process Time [5]

· Drugs in compliance are normally issued within twenty (20) government working days of receipt of complete and an accurate CoPP application.

Certificates may not be issued [5]

Returned – missing information application with a letter identifying the missing information.

Rejected – manufacturing facilities are not in compliance with good manufacturing practices (GMPs).

Denied – drug products are not compliance as per regulation (e.g., misbranded drug)

Ribbons on CoPPs [4, 14]

Colored ribbons designate the type of CoPP:

Red: Approved drug product, API, OTC marketed as per monograph, and export only drugs.

Blue: Unapproved drug product not marketed in the country.

Yellow: Drug manufactured with foreign manufacturing sites.

CoPP Fee Schedule [2, 5]

· First Certificate (original) – ($175.00) 11025Rs/-

· Second Certificate – ($90.00) 5670 Rs/-

· Third and subsequent certificates –($40.00) 2520Rs/-

Expiration of CPP [5, 14]

· Certificate expires on 2 years from the notarization date or as noted.

· After expiry date, a new CoPP application has to be submitted.

Benefits [2]

· To grow business in foreign country, necessary to obtain the CoPP certificates by pharmaceutical companies.

Summary [5]

· Know the requirements of the importing country prior to submitting an application while obtaining CoPP.

· Complete Application Form no. 3613b.

· Submission of required documentation.

REFERENCES:

1. Mission pharma http://www.missionpharma.com/faqs

2. Guidance Document on application for a CoPP (GUI-0024) http://cdsco.nic.in/writereaddata/Guidance%20documents.pdf

3. Essential medicine and health product information portal,who http://apps.who.int/medicinedocs/en/d/Jwhozip43e/16.html

4. USFDA,U.S. Department of health and Huma service http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ImportsandExportsCompliance/ucm348825.htm

5. USFDA, Protecting and promoting public health http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM314784.pdf

6. WHO, ESSENTIAL MEDICINES AND HEALTH PRODUCThttp://apps.who.int/medicinedocs/en/d/Jwhozip43e/16.html GENPACT Pharamalink, global regulatory affairs medical.MEDICAL REGULATORY AFFAIRS TODAY, posted: 2013

7. WHO / CoPP certificate. http://en.wikipedia.org/wiki/Certificate_of_pharmaceutical_product lastly cited on 1^st april 2015.

9. Import and Export Policy for Health Products under the Food and Drugs Act and its Regulations (POL-0060) http://www.hc-sc.gc.ca/dhp-mps/compli-conform/import export/pol0060_biuuifeng.php

10. iDMLA.http://idmla.guj.nic.in/Help/SOP-For-Certificates-New.pdf

11. PHARMEXIL. http://www.pharmexcil.com/data/uploads/COPP_by_Shri_A_Chandra_Sekhara_Rao,ADCI,CDSCO.pdf http://www.pharmexcil.com/data/uploads/COPP_by_Shri_A_Chandra_Sekhara_Rao,ADCI,CDSCO.pdf http://www.pharmexcil.com/data/uploads/COPP_by_Shri_A_Chandra_Sekhara_Rao,ADCI,CDSCO.pdf

12. HPRA, Health Product Regulatory Authority. https://www.hpra.ie/homepage/medicines/regulatory-information/export-certification

13. The elsmar cove discussion forum. http://elsmar.com/Forums/showthread.php?t=55299

14. Relevance of a Certificate of Pharmaceutical Product for Registration and Life Cycle Management of Imported Drugs.http://dgra.de/media/pdf/studium/masterthesis/master_sahl_a.pdf