Model statement of licensing status of pharmaceutical product(s)
Please refer to the guidelines for full instructions on how to complete this form and information on the implementation of the Scheme.
The 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.
Statement of licensing status of pharmaceutical product(s)1
No. of statement:
Exporting (certifying) country:
Importing (requesting) country:
This statement indicates only whether or not the following products are licensed to be put on the market in the exporting country.
|Name of product||Dosage form||Active ingredient(s)2 and amount(s) per unit dose:||Product-licence No. and date of issue3|
The certifying authority undertakes to provide, at the request of the applicant (or, if different, the product-licence holder), a separate and complete Certificate of a Pharmaceutical Product in the format recommended by WHO, for each of the products listed above.
Address of certifying authority:
Name of authorized person:
Telephone/fax numbers: Signature:
Stamp and date:
This statement conforms to the format recommended by the World Health Organization.
- This statement is intended for use by importing agents who are required to screen bids made in response to an international tender and should be requested by the agent as a condition of bidding. The statement indicates that the listed products are authorized to be placed on the market for use in the exporting country. A Certificate of a Pharmaceutical Product in the format recommended by WHO will be provided, at the request of the applicant and, if different, the product-licence holder, for each of the listed products.
- Use, whenever possible, International Nonproprietary Names (INNs) or national nonproprietary names.
- If no product licence has been granted, enter "not required", "not requested", "under consideration" or "refused" as appropriate.