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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 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)

1 The certificate is intended to be product specific. The approved information for different dosage forms of the same active substance frequently differs in fundamental aspects. Confusion will inevitably arise if information relating to different products, or even different usage forms, is attached to the same certificate.

Name and dosage form of product: ...................................................

Name and amount of each active ingredient:2 ...................................


.......................................................................................................
.......................................................................................................

Manufacturer, and/or when applicable, the person responsible for placing the product on the market:


.......................................................................................................
Address(es): ..................................................................................


It is certified that:


-- This product has been authorized to be placed on the market for use in this country.


Number of permit and date of issue (if applicable): .......................
.......................................................................................................


-- The enclosed documents constitute the complete text of all labelling and prescribing information which is authorized for use in this country.


-- This product has not been authorized to be placed on the market for use in this country for the following reasons:....................................................................
.......................................................................................................
.......................................................................................................

2 Use, whenever possible, international nonproprietary names (INNs) or national nonproprietary names.

It is also certified that (a) the manufacturing plant in which the product is produced is subject to inspections at suitable intervals and (b) the manufacturer conforms to requirements for good practices in the manufacture and quality control, as recommended by the World Health Organization, in respect of products to be sold or distributed within the country of origin or be exported. (See Explanatory Notes.)

....................................................



.......................................

(Signature of designated authority)



(Place and date)

Explanatory Notes

Certificate of Pharmaceutical Product(s)

This certificate is intended to define the status of the pharmaceutical product and its manufacturer in the exporting country. It is issued by the competent authority in the exporting country in accordance with the requirements of the competent authority of the importing country. It may be required by the importing country at the time of the first importation and subsequently if confirmation or updating is required.

The requirements for good practices in the manufacture and quality control of drugs mentioned in the certificate refer to the text adopted by the Twenty-eighth World Health Assembly in its resolution WHA28.65 (see Official Records No.226, 1975, Annex 12, Part 1).

Batch certificates

Certification of individual batches of a pharmaceutical product or substance is only undertaken exceptionally by the competent authorities of Member States. Even then, it is rarely applied other than to vaccines and other biologicals. If certificates of individual batches of products covered by a Certificate of a Pharmaceutical Product is required, such certificates could be issued either by the manufacturer or by the competent authority of the exporting Member State, according to the nature of the product and the requirements of the exporting Member State or of the importing Member State. The batch certificate would indicate the name and dosage form of the product, the batch number, the expiry date and storage conditions, a reference to the Certificate of a Pharmaceutical Product and a statement that the batch conforms either to the requirements of the competent authority for sale or distribution within the exporting Member State (with reference to the authorization) or, where appropriate, to published specifications or to established specifications to be provided by the manufacturer. The certificate could also include data on packaging, labelling, nature of the container, the date of manufacture, results of analysis, stability data and other information such as an approved technical summary of the data regarding safety and efficacy on which the domestic marketing authorization is based.

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