Manufacturer’s/Official1 Batch Certificate of a Pharmaceutical Product
No. of Certificate........
Importing (requesting) country:
Proprietary name (if applicable) and dosage form:
Active ingredient(s)2 and amount(s) per unit dose:
Details of product licence and product certificate issued in the exporting country
Product-licence holder: |
Product-licence number: |
Date of issue: |
Product licence issued by: |
|
Product-certificate number: 3 |
Batch number: |
Date of manufacture: |
Shelf-life (years): |
Contents of container: |
Nature of secondary container: |
Nature of primary container/wrapping: |
Specific storage conditions recommended for the product: |
Temperature range: |
|
Quality analysis
What specifications apply to this dosage form? |
Either specify the pharmacopoeia or append the specifications. |
Does the batch comply in all particulars with the above specifications? |
yes  no |
Append certificate of analysis.4 |
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It is hereby certified that the above declarations are correct and that 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 the exporting countries.
Name and address of authorized person: |
Signature of authorized person: |
| |
Stamp: |
Telephone/fax numbers: |
Date: |
This certificate conforms to the format recommended by the World Health Organization (General instructions and explanatory notes overleaf)
General instructions
Please refer to the guidelines for further information on how to complete this form and on the implementation of the Scheme.
Forms should be completed using a typewriter to ensure legibility.
A cross should be placed in boxes as appropriate to indicate which options apply.
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 and biologicals. For other products, the responsibility for any request 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 This refers to the Certificate of a Pharmaceutical Product as recommended by the World Health Organization.
4 Identify and explain any discrepancies from specifications.
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