Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Close this folder7. International trade in pharmaceuticals
Close this folderGuidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce1
View the document1. Provisions and objectives
View the document2. Eligibility for participation
View the document3. Requesting a certificate
View the document4. Issuing a certificate
View the document5. Notifying and investigating a quality defect
View the documentReferences
View the documentAppendix 1. Model Certificate of a Pharmaceutical Product
View the documentAppendix 2. Model Statement of Licensing Status of Pharmaceutical Product(s)
View the documentAppendix 3. Model Batch Certificate of a Pharmaceutical Product
View the documentAppendix 4. Glossary and index
View the documentWorld Health Assembly resolution WHA50.3: Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
View the documentGuidelines on import procedures for pharmaceutical products1
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 

Appendix 2. Model Statement of Licensing Status of Pharmaceutical Product(s)

No. of Statement ___________

Exporting (certifying) country:

 

Importing (requesting) country:

Statement of Licensing Status of Pharmaceutical Product(s)1

This statement indicates only whether or not the following products are licensed to be put on the market in the exporting country. Applicant (name/address):

Name of product

Dosage form

Active ingredients(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 (general instructions and explanatory notes below).

General instructions

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.

Explanatory notes

1 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.

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

3 If no product licence has been granted, enter “not required”, “not requested”, “under consideration” or “refused” as appropriate.

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

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