See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/285311046

Certificate of pharmaceutical product CoPP

Article in Research Journal of Pharmacy and Technology · November 2015

DOI: 10.5958/0974-360X.2015.00260.7

CITATION READS
1 53,816

3 authors:

Meena Pooja Ketan Shah

Zydus Research Centre Shree Naranjibhai Lalbhai Patel College of Pharmacy
2 PUBLICATIONS 1 CITATION 57 PUBLICATIONS 420 CITATIONS

SEE PROFILE SEE PROFILE

Dr. Pankaj Kapupara

RK University
58 PUBLICATIONS 350 CITATIONS

SEE PROFILE

All content following this page was uploaded by Dr. Pankaj Kapupara on 01 December 2015.

The user has requested enhancement of the downloaded file.

 Research J. Pharm. and Tech. 8(10): October 2015

ISSN 0974-3618 (Print) www.rjptonline.org

0974-360X (Online)

REVIEW ARTICLE

Certificate of pharmaceutical product CoPP

Meena Pooja*, Dr. Shah Ketan, Dr. Kapupara Pankaj
School of Pharmacy, RK University, Rajkot – 360020, Gujarat, India.
*Corresponding Author E-mail: poojameena4557@gmail.com

ABSTRACT:
This review includes basics of CoPP, origin of CoPP, types, types of drug includes in CoPP, procedure to obtain
CoPP, requirement for CoPP, applicant, examples, format and content and benefits of CoPP. A CoPP is given by
the drug regulator not before conducting an inspection of the manufacturing plant. The Indian pharmaceutical
market is at around Rs65, 000 crore and out of this, export for around Rs30, 000 crore and certificate is valid for
a two years period.

KEYWORDS: CoPP, regulation, foreign market, trade.

INTRODUCTION: Aim:
This CoPP certificate is issued by the National Health A CoPP demonstrates in question that the imported
Authorities upon request from the customer, the medicine is of the appropriate standard of quality, safety
authorities or the manufacturer of product in the and efficacy to allow marketing in their market, having
importing country. This certificate is for a specific undergone rigorous testing and examination to
product whether the it is marketed in the country of Regulatory Authorities in the exporting country and also
origin or not and also states that the product’s demonstrates that it follows the correct guidelines and
manufacturer complies with GMP and whether they are procedures of Good Manufacturing Practice (GMP),
inspected regularly by the national health authorities[1, increasing the level of quality and indeed safety of the
7] product. [2,7]

A CoPP is in the format recommended by the WHO. It is SCOPE:

the importing country who requires the CPP for the The CoPP is needed when the product tends that it is
pharmaceutical product and a special type of certificate intended for registration or its renewal (licensing,
which enables a given pharmaceutical product to be authorization or prolongation)) by the importing country,
registered and marketed in the exporting country of with the scope that the product are distributed or
interest and forms parts of the marketing authorization commercialized in that country.
application. [1]
A Certificate has been recommended so that it helps the
This is issued by the Inspectorate and the fabricator of undersized drug regulatory authorities (DRA) or also
the product having GMP position and also the position without proper quality assurance (QA) facilities in
of the pharmaceutical, radiopharmaceutical, biological, importing countries by WHO and also it can assess the
or veterinary product. [2] pharmaceutical products quality as per prerequisite of
importation or registration.
The approved information for different pharmaceutical A CoPP, which recommends WHO to national
forms and strengths is varied so it is always issued for a authorities for its esurient that confirmed method is
single product. [1] analytical by the national laboratory, to view and also
necessary to adapt information of product as per
Received on 12.08.2015 Modified on 21.08.2015 labelling requirements also bioequivalence and also
Accepted on 10.09.2015 © RJPT All right reserved some stability data. Regulatory practices vary in
Research J. Pharm. and Tech. 8(10): Oct., 2015; Page 1449-1453 importing countries.
DOI: 10.5958/0974-360X.2015.00260.7

1449
 Research J. Pharm. and Tech. 8(10): October 2015

Also, dossiers assessment needed, with different levels company or by the applicant;
and requirements complexity to satisfy quality assurance vi) states the names of the importing and exporting
of drugs. (certifying) countries
Inspection: Here besides three types of CoPPs also we have
The DRA gives a CoPP only after conducting an another specific type of the U.S. FDA CoPPs: [14]
inspection of the manufacturing product. (The The U.S. FDA issued “Pilot- CoPP” for the remaining
Pharmaceutical market of India is estimated at around products which are neither exported nor manufactured in
Rs65, 000 crore. Out of which, accounts of export for the United States. It is only when no other country has
around Rs30, 000 crore.)[1, 2] given an approval for the finished medicinal product
registration.
Types of CoPP :
1) WHO 1975 type CoPP Certificate of a pharmaceutical product model[1,2,3]
The WHO 1975 version is a certificate to be issued by The form is suitable for generation by computer. It
exporting country regulatory authority stating: should be submitted as hard copy, with responses printed
in type rather than handwritten.
a) the authorized product has to be placed on the
market for its use in the country also, the permit number Reference Number:
and issue date, or Date:
b) that the nonauthorized product has placed on the This certificate conforms the format of WHO.
market for its use in the country and also add the reasons Certificate no.:
why it is needed; Importing country name:
Also, that; Exporting country name:
a) As recommended by World Health Organization, 1. Name and its dosage form:
the manufacturer of product conforms to GMP 1(a). API(s) and its amount per dose
requirements. Also see attached for (complete composition including
b) only within the country of origin the products to be excipients),
sold or distributed ;or 1(b) Is the product placed for use in the exporting
c) To be exported to manufacturing plant where the country or not?
product is produced and at suitable intervals subject to 1(c) If the product present on the market in the exporting
inspections. country?
● If the answer is yes, continue with section 2 and
2) WHO 1988 type CoPP omit section 3.
Unlike the WHO 1975 version, the competent authority ● If the answer is no, omit section 2 and continue with
of the exporting country should have: section 3.
● All labelling copies. 2.1. Number of product license and date of issue:
● Product detailed information in the country of origin 2.2. Product license holder (name and address):
(see annex 3). 2.3. Status of product license holder:
2.3.1. For b and c categories, the name of product and
3) WHO 1992 type CoPP address of its manufacturer must be present:
This is intended for use by the competent authority of an 2.4. if approval appended or not?
importing country in two situations: 2.5. Is the officially approved product information
a) When the question arises related to importation and complete and readily available according to the license?
sale license; and 2.6. Applicant for certificate, if different from license
b) For license renew, extend, review or changes. holder (name and address):
3. Certificate applicant (name, address and required
The following information required for the certificate: info):
i) Whether a licensed product is required to be placed on 3.1 Status of applicant:
the market or not. 3.2 For (b) and (c) categories, the name and address of
ii) Also if the satisfied information submitted by the the manufacturer producing the dosage form is:
applicant that the certifying authority of the manufacture 3.3 if the marketing authorization not required, not
of the product undertaken by another party requested, under consideration or refused ?
iii) Inspection have been carried out of the manufacturer 3.4 other additional information
of product; 3.5 If the periodic inspection of the manufacturing plant
iv) If the certificate is provisional or permanent; in which the dosage form is produced or not/not
v) Is the dosage forms, packages and/or labels of a applicable?
finished dosage form manufactured by an independent If not or not applicable, proceed to question 5;
1450
 Research J. Pharm. and Tech. 8(10): October 2015

4. Routine inspections periodicity (years): recommendation or not?

4.1. Has the manufacture been inspected or not? 5. The information submitted by the applicant satisfy the
4.2 The operations and facilities conform to GMP 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:

OR
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.
1451
 Research J. Pharm. and Tech. 8(10): October 2015

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: ● Awareness is necessary for the drugs that are legal

● The plant in which the product is produced, in some countries may be illegal in other countries.
inspection is required at suitable interval.
● The manufacturer conforms to requirements of Importation for Personal Use [9]
GMP in the Organization, with respect to the products ● Risky to health, such drugs are prevented from
to be distributed within the country of origin or can be importation.
exported. ● Also Enforcement actions have been taken
Also, Signature of authority who designed, Place and domestically..
date are also mentioned.
Types of drugs for which CoPPs may be issued [5]
How to obtain CoPP? [2, 8, 11] ● Approved drug products
● To obtain a CoPP, a request is made to the exporting ● Active pharmaceutical ingredients (API)
country’s health authority by the Marketing ● Over the counter drug (OTC) products
Authorization Holder (MAH). ● Unapproved drug products
● An authorized person issues the CoPP and returns it ● Homeopathic drugs
to the MAH. Also other documents required to obtain a
CoPP including an application for Export Certificate Who can apply for CPP? [5, 12]
form, evidence of a GMP certificate (if applicable),  A complete application for export certification must
Manufacturing License and the last approved SPC be submitted by the person/company who exports the
(Summary of Product Characteristics). drug.
 The certification is intended for a drug which :
Content and format [8, 12] meets the applicable requirements of the Act or Food
 Importing country: Drug and Cosmetic Act 801(e)(1) requirements [21
 Exporting country: U.S.C.381(e)(1)]
 Name, form of dosage and its composition of the
product (API per unit dose). Process to apply for a CoPP [5, 10, 12]
 Registration Information (licensing) a)Submit Form no. 3613b– Located on the FDA internet
 Marketing status of the product in the exporting www.fda.gov/downloads/AboutFDA/Reports Manuals
country. Forms/Forms/UCM052388
 license no. of product (containing license holder b) Requirements for CoPP application:
 Applicant Contact Information
details; involvement of license holder in manufacturing
if any) and also add date of issue,  Trade name (the drug product’s brand name)
 Summary of technical basis on which the product  Bulk Substance Generic Name
 Name of Applicant
has been licensed (if required by the issuing authority)
 Currently marketed product’s information  Status of Product License holder
 Details about the product’s applicant  Listing of manufacturing location on CPP
 Complete Manufacturing Facility Address
 If lacking is there in the exporting country, need to
mention the information about reasons.  Facility Registration Number
 Importing countries
Certificates May Be Issued [5, 12]  Authorization to Release Information
 Legally marketable drug in the country.  Number of certificates requested
 Nonauthorized drugs for distribution in the country  Certification Statement
which are legally exported to a foreign country.  Billing contact
 For a foreign manufactured drug.  Marketing Status in the Exporting Country
Exportation for Personal Use [9]
1452
 Research J. Pharm. and Tech. 8(10): October 2015

Additional Required Information [5] CoPP Fee Schedule [2, 5]

Foreign Manufactured Drugs Exportation certification  First Certificate (original) – ($175.00) 11025Rs/-
from the country for the Sites of Foreign Manufacturing  Second Certificate – ($90.00) 5670 Rs/-
Approved Drug Products NDA, ANDA, BLA or  Third and subsequent certificates –($40.00)
Approval Letter 2520Rs/-
 Outer Container Label(s)
 Package Insert Expiration of CPP [5, 14]
 Package Container (Immediate)  Certificate expires on 2 years from the notarization
 Status of Product-license Holder date or as noted.
Unapproved Drug Products Product Identification  After expiry date, a new CoPP application has to be
Statement Formulation page submitted.
Over-the-Counter (OTC) Drug products
 Title of the applicable monograph Benefits [2]
 Product Label(s)  To grow business in foreign country, necessary to
 Immediate Package Container Label obtain the CoPP certificates by pharmaceutical
companies.
Active Pharmaceutical Ingredients (API) main sample of
the bulk container. Summary [5]
Export only formulation page.  Know the requirements of the importing country
COPPs should be issued as per Model Certificate of prior to submitting an application while obtaining CoPP.
Pharmaceutical Product recommended by World Health  Complete Application Form no. 3613b.
Organization, given in TRS 86[10] of WHO.  Submission of required documentation.

Attachments to CoPP [13] REFERENCES:

1.
 Two sets of attachments required for one country 2.
Mission pharma http://www.missionpharma.com/faqs
Guidance Document on application for a CoPP (GUI-0024)
(one set to attach to the certificate package and one set http://cdsco.nic.in/writereaddata/Guidance%20documents.pdf
for FDA files). 3. Essential medicine and health product information portal,who
 Attachments must not be more than five pages per http://apps.who.int/medicinedocs/en/d/Jwhozip43e/16.html
4. USFDA,U.S. Department of health and Huma service
certificate. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInfor
 Applicant is responsible for consulting with the mation/ImportsandExportsCompliance/ucm348825.htm
importing country to determine the type of the 5. USFDA, Protecting and promoting public health
information required. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalPro
cess/SmallBusinessAssistance/UCM314784.pdf
Process Time [5] 6. WHO, ESSENTIAL MEDICINES AND HEALTH
 Drugs in compliance are normally issued within PRODUCThttp://apps.who.int/medicinedocs/en/d/Jwhozip43e/16
twenty (20) government working days of receipt of .html GENPACT Pharamalink, global regulatory affairs
complete and an accurate CoPP application. medical.MEDICAL REGULATORY AFFAIRS TODAY,
posted: 2013
7. WHO / CoPP certificate.
Certificates may not be issued [5] http://en.wikipedia.org/wiki/Certificate_of_pharmaceutical_produ
st
Returned – missing information application with a letter ct lastly cited on 1 april 2015.
identifying the missing information. 9. Import and Export Policy for Health Products under the Food and
Drugs Act and its Regulations (POL-0060) http://www.hc-
Rejected – manufacturing facilities are not in compliance sc.gc.ca/dhp-mps/compli-conform/import
with good manufacturing practices (GMPs). export/pol0060_biuuifeng.php
Denied – drug products are not compliance as per 10. iDMLA.http://idmla.guj.nic.in/Help/SOP-For-Certificates-
regulation (e.g., misbranded drug) New.pdf
11. PHARMEXIL.
http://www.pharmexcil.com/data/uploads/COPP_by_Shri_A_Cha
Ribbons on CoPPs [4, 14] ndra_Sekhara_Rao,ADCI,CDSCO.pdf
Colored ribbons designate the type of CoPP: http://www.pharmexcil.com/data/uploads/COPP_by_Shri_A_Cha
Red: Approved drug product, API, OTC marketed as per ndra_Sekhara_Rao,ADCI,CDSCO.pdf
http://www.pharmexcil.com/data/uploads/COPP_by_Shri_A_Cha
monograph, and export only drugs. ndra_Sekhara_Rao,ADCI,CDSCO.pdf
Blue: Unapproved drug product not marketed in the 12. HPRA, Health Product Regulatory Authority.
country. https://www.hpra.ie/homepage/medicines/regulatory-
Yellow: Drug manufactured with foreign manufacturing information/export-certification
13. The elsmar cove discussion forum.
sites. 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
1453

View publication stats