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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 4 (b): Certificate of a Pharmaceutical Product

Certificate Of a Pharmaceutical Product1

No. of Certificate........
Exporting (certifying) country:
Importing (requesting) country:

Proprietary name (if applicable) and dosage form:

Active ingredient(s)2 and amount(s) per unit dose:3

1. Is this product licensed to be placed on the market for use in the exporting country?4 If yes, complete box A. If no, complete box B.

A

Product-licence holder:

Status of licence holder:5

a b c d

Number of product licence6 and date of issue:

Is an approved technical summary appended?7

yes no

Is the attached product information complete and consonant with the licence?

yes no not provided

Applicant for certificate if different from the licence holder:8

B

Applicant for certificate:

Status of applicant:5

a b c d

Why is authorization lacking?

not required not requested under consideration refused

Remarks:9

2. Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced?

yes

If no, proceed to question 3

 

no


Periodicity of routine inspections (years):

   

Has the manufacture of this type of dosage form been inspected?

yes

no

Do the facilities and operations conform to GMP as recommended by the World Health Organization?10

yes

no

3. Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product undertaken by another party?”

yes no If no, explain:

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.

A cross should be placed in boxes as appropriate to indicate which options apply.

Additional sheets should be appended, as necessary, to accommodate remarks and explanations.

Explanatory notes

1 This certificate, which is in the format recommended by WHO, establishes the status of the pharmaceutical product and of the applicant for the certificate in the exporting country. It is for a single product only since manufacturing arrangements and approved information for different dosage forms and different strengths can vary.

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

3 A qualitative listing of other ingredients contained in the dosage form should be appended.

4 When applicable, append details of any restriction applied to the sale, distribution, or administration of the product that is entered on the product licence.

5 Specify whether the person responsible for placing the product on the market:

(a) manufactures the active ingredients and the finished dosage form;

(b) manufactures the finished dosage form;

(c) packages and/or labels a finished dosage form manufactured by an independent company; or

(d) is involved in none of the above.

6 Indicate, when applicable, if the licence is provisional, pending technical review.

7 This refers to the document, prepared by certain national regulatory authorities, that summarizes the technical basis on which the product has been licensed.

8 In this circumstance, permission for issuance of the certificate is required from the product-licence holder.

9 Please indicate the reason the applicant has provided for not requesting registration:

(a) the product has been developed exclusively for the treatment of conditions - particularly tropical diseases - not endemic in the country of export;

(b) the product has been reformulated with a view to improving its stability under tropical conditions;

(c) the product has been reformulated to exclude excipients not approved for use in pharmaceutical products in the country of import;

(d) the product has been reformulated to meet a different maximum dosage limit for an active ingredient;

(e) any other reason, please specify.

10 The requirements for good practices in the manufacture and quality control of drugs referred to in the certificate are those adopted by the Twenty-eighth World Health Assembly in its resolution WHA28.65 (see WHO Official Records, No. 226, 1975, Annex 12, Part 1). Proposals for the amendment of these requirements are included in the Thirty-second Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (WHO Technical Report Series, No. 822, 1992, Annex 1). Recommendations specifically applicable to biological products have been formulated by the WHO Expert Committee on Biological Standardization (WHO Technical Report Series, No. 822, 1992, Annex 1).

11 This section is to be completed when the product-licence holder or applicant conforms to status (c) or (d) as described in note 5 above. It is of particular importance when foreign contractors are involved in the manufacture of the product. In these circumstances the applicant should supply the certifying authority with information to identify the contracting parties responsible for each stage of manufacture of the finished dosage form, and to indicate the extent and nature of any controls exercised over each of these parties.

 

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