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
Fermer ce répertoire1. INTRODUCTION
Afficher le document1.1 Background
Afficher le document1.2 WHO Certification Scheme
Afficher le document1.3 Types of Certificates
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
 

1.3 Types of Certificates

The different types of certificates developed by WHO over the last two decades under the Certification Scheme, as well as examples of other certificates issued by drug regulatory authorities in the exporting countries are described below.

1.3.1 WHO-type Certificate

a) Certificate of Pharmaceutical Product (WHO 1975 type)

The 1975 version of the WHO-type Certificate of a Pharmaceutical Product is a certificate to be issued by a competent authority (regulatory authority) of the exporting country stating:

(i) that the product has been authorized to be placed on the market for use in the country including the number of permit and date of issue, or that the product has not been authorized to be placed on the market for use in the country and the reasons why;

(ii) that: a) the manufacturing plant in which the product is produced is subject to inspections at suitable intervals; and b) the manufacturer conforms to GMP requirements as recommended by WHO in respect of products to be sold or distributed within the country of origin or to be exported.

The certificate combines (i) and (ii) above in a single document (see annex 2).

b) Certificate of a Pharmaceutical Product (WHO 1988 type)

The 1988 format of the Certificate of a Pharmaceutical Product is similar to the 1975 version, but in addition the competent authority of the exporting country is required to provide copies of the complete text of all labelling and product information which is authorized in the country of origin (see annex 3).

c) Certificate of a Pharmaceutical Product (WHO 1992 type)

This is intended for use by the competent authority of an importing country in two situations: a) when the product in question is under consideration for a product license that will authorize its importation and sale; and b) when administrative action is required to renew, extend, vary or review such a license (see annex 4). The certificate provides information on the following:

i) whether a product is licensed to be placed on the market, and if not, the reasons why;

ii) whether the applicant manufactures the dosage forms, packages and/or labels a finished dosage form manufactured by an independent company, or is involved in none of the above;

iii) if the manufacturer of the product has been inspected and the periodicity of inspection;

iv) if the certificate is provisional, pending technical review;

v) whether the information submitted by the applicant satisfies the certifying authority on all aspects of the manufacture of the product undertaken by another party;

vi) states the names of the importing and exporting (certifying) countries.

d) Statement of Licensing Status (WHO 1992 type)

This is an attestation issued by a national regulatory authority of an exporting country stating that a license has been issued for a specified product or products for use in the exporting country. It is intended for use by importing agents when considering bids made in response to an international tender and is useful only to facilitate the screening and preparation of information (see annex 4).

e) Batch Certificate (WHO-type)

A certificate issued by either the manufacturer or by the competent authority of an exporting country confirming that the quality of a specific batch of the product conforms to specifications approved at the time of issuance of product license by the competent authority in the exporting country. The batch certificate indicates the name, dosage form, batch number, expiry date, storage condition of the product as well as a reference to the Certificate of a Pharmaceutical Product (see annex 4).

1.3.2 Other Certificates (non WHO-type)

a) Free Sale Certificate

A certificate issued by a national regulatory authority of an exporting country based on national legislation confirming that the product is freely sold in the country but without any indication that the product is evaluated for safety and efficacy and is registered for use in the country.

b) GMP Certificate

A certificate issued by a national regulatory authority of an exporting country confirming that the manufacturer complies with GMP requirements.

c) Analytical Batch Certificate

A certificate issued by a manufacturer confirming that the quality of a specific batch corresponds to the specifications for the product at the time when the batch was released. It contains results of analytical tests but does not mention the relevant Certificate of a Pharmaceutical Product issued by the regulatory authority of the exporting country as recommended by WHO.

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