Document complet  |  Dérouler chapitre  |  Etendre sommaire  |  Version HTML imprimable
Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGMENTS
Afficher le documentPREFACE
Afficher le documentEXECUTIVE SUMMARY
Ouvrir ce répertoire et afficher son contenu1. INTRODUCTION
Afficher le document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Afficher le document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Ouvrir ce répertoire et afficher son contenu4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Ouvrir ce répertoire et afficher son contenu5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Afficher le document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Ouvrir ce répertoire et afficher son contenu7. SUMMARY ANALYSIS
Afficher le document8. CONCLUSIONS
Afficher le documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Afficher le documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Afficher le documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Afficher le documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Afficher le documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Afficher le documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Afficher le documentANNEX 4 (b): Certificate of a Pharmaceutical Product
Afficher le documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Afficher le documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Afficher le documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Afficher le documentANNEX 6: List of Participants in the Study
Afficher le documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Afficher le documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Afficher le documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Ouvrir ce répertoire et afficher son contenuANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Afficher le documentBACK COVER
 

ANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)

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 placed on the market for use in the exporting country. Applicant (name/address):

Proprietary name (if applicable)

Dosage form

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

Product-licence no. & date of issue3

 

 

 

 

     

The certifying authority undertakes to provide, at the request of the applicant (and, 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:

 

Signature:

Telephone/fax numbers:

Stamp and 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.

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.

2 Use, whenever possible, International Non proprietary 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.

 

vers la section précédente
vers la section suivante
 
 
Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 1 décembre 2019