Manufacturers/Official¹ Batch Certificate of a Pharmaceutical Product

This certificate conforms to the format recommended by the World Health Organization (general instructions and explanatory notes attached)

1. No. of Certificate:

2. Importing (requesting) authority:

3. Name of product

3.1. Dosage form

3.2 Active ingredient(s)² and amount(s) per unit dose:

3.2.1 Is the composition of the product identical to that registered in the country of export?yes/no/not applicable³ (key in as appropriate)

If no: please attach formula (including excipients) of both products.

4. Product-licence holder⁴ (name and address):

4.1 Product-licence number⁴:

4.2 Date of issue⁴:

4.3 Product licence issued by⁴:

4.4 Product certificate number^4,5:

5.1 Batch number:..............

5.2 Date of manufacture:

5.3 Shelf life (years): ..............

5.4 Contents of container:

5.5 Nature of primary container:

5.6 Nature of secondary container/wrapping:

5.7 Specific storage conditions:

5.8 Temperature range:

6 Remarks⁶:

7. Quality analysis:

7.1 What specifications apply to this dosage form. Either specify the pharmacopoeia or append company specifications.⁷

7.1.1 In the case of a product registered in the exporting country, have these company specifications⁷ been accepted by the competent authority? yes/no
(key in as appropriate)

7.2 Does the batch comply with all parts of the above specifications?
yes / no (key in as appropriate)

7.3 Append certificate of analysis⁸

It is hereby certified that the above declarations are correct and that the results of the analyses and assays on which they are based will be provided on request to the competent authorities in both the importing and exporting countries.

Name and address of authorized person:

Telephone no:. .............. Fax number:

Signature of authorized person:

Stamp and date:

General instructions

Please refer to the guidelines for full instructions on how to complete this form and information on the implementation of the Scheme.

These forms are suitable for generation by computer. They should always be submitted as hard copy, with responses printed in type rather than handwritten.

Additional sheets should be appended, as necessary, to accommodate remarks and explanations.

Explanatory notes

Certification of individual batches of a pharmaceutical product is only undertaken exceptionally by the competent authority of the exporting country. Even then, it is rarely applied other than to vaccines, sera and biologicals. For other products, the responsibility for any requirement to provide batch certificates rests with the product-licence holder in the exporting country. The responsibility to forward certificates to the competent authority in the importing country is most conveniently assigned to the importing agent.

Any inquiries or complaints regarding a batch certificate should always be addressed to the competent authority in the exporting country. A copy should be sent to the product- licence holder.

¹ Strike out whichever does not apply.

² Use, whenever possible, International Nonproprietary Names (INNs) or national nonproprietary names.

³ “Not applicable” means that the product is not registered in the country of export.

⁴ All items under 4 refer to the product licence or the Certificate of a Pharmaceutical Product issued in the exporting country.

⁵ This refers to the Certificate of a Pharmaceutical Product as recommended by the World Health Organization.

⁶ Indicate any special storage conditions recommended for the product as supplied.

⁷ For each of the parameters to be measured, specifications give the values that have been accepted for batch release at the time of product registration.

⁸ Identify and explain any discrepancies from specifications. Government batch release certificates issued by certain governmental authorities for specific biological products provide additional confirmation that a given batch has been released, without necessarily giving the results of testing. The latter are contained in the manufacturer’s certificate of analysis.

The layout for this Model Certificate is available on diskette in Word Perfect from the Division of Drug Management and Policies, World Health Organization, 1211 Geneva 27, Switzerland.