Apostille Service for Certificate of Pharmaceutical Product (COPP)

The Certificate of Pharmaceutical Product (COPP), issued in the format as recommended by the World Health Organization (WHO), is a document that is internationally recognized by national drug regulatory authorities for establishing the status of a pharmaceutical product under a national drug product licensing system.

COPP can be issued for registered therapeutic products or unregistered therapeutic product made for export only or under product evaluation. The therapeutic product must be produced under a comprehensive system of quality assurance, conforming to Good Manufacturing Practice (GMP) standards as mandated by WHO.

step 1:

Upload your document in PDF format.

step 2:

Fill order form and verify the authenticity of your document.

step 3:

Decide method of shipping.

step 4:

Pay a total fee of $57

The COPP is specific for one product as well as one country of import. Among other information, the certificate includes the following data:

Information on whether or not a product is sold in its country of origin.

Details of the manufacturing site.

Product details, such as the formulation.

This certificate conforms to the format recommended by the World Health Organization

No. of certificate

Exporting (certifying country):

Importing (requesting country):

Certificate Of Pharmaceutical Product Apostille

1. Name and dosage form of the product:

1.1. Active ingredient(s)2 and amount(s) per unit dose3:

For complete composition including excipients, see attached4:

1.2. Is this product licensed to be placed on the market for use in the exporting country?5 (yes/no)

1.3 Is this product actually on the market in the exporting country?

If the answer to 1.2. is yes, continue with section 2A and omit section 2B.

If the answer to 1.2 is no, omit section 2A and continue with section 2B6:

2.A.1. Number of product licence7 and date of issue:

2.A.2. Product licence holder (name and address):

2.A.3. Status of product licence holder8: (Key in appropriate category as defined in note 8)

2.A.3.1. For categories b and c the name and address of the manufacturer producing the dosage form is9:

2.A.4. Is a summary basis for approval appended?10 (yes/no)

2.A.5. Is the attached, officially approved product information complete and consonent with the licence?11 (yes/no/not provided)

2.A.6. Applicant for certificate, if different from licence holder (name and address)12:

2.B.1. Applicant for certificate (name and address):

2.B.2. Status of applicant: (Key in appropriate category as defined in footnote 8)

2.B.2.1. For categories (b) and (c) the name and address of the manufacturer producing the dosage form is:9

2.B.3. Why is marketing authorization lacking? (not required/not requested/under consideration/refused)

2.B.4. Remarks13:

3. Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced? (yes/no/not applicable)14

If not or not applicable, proceed to question 4.

3.1. Periodicity of routine inspections (years):

3.2. Has the manufacture of this type of dosage form been inspected? (yes/no)

3.3 Do the facilities and operations conform to GMP as recommended by the World Health Organization?15 (yes/no/not applicable)14

4. Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product16: (yes/no)

If no, explain:

Address of certifying authority:

Telephone:

Fax:

Name of authorized person:

Signature

Stamp and date

To have this COPP certificate Apostilled, you can use our E-Apostille (Electronic Apostille) service for your COPP Certificate by uploading your document in PDF format to our website and fill up our order form, and specify which type of mail/courier we should use to send you back the Apostilled document. This way you will save a one-way postal (or courier) service cost, and time. Generally speaking, our fees for this type of service is a fixed $62.0.