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
 

5. Notifying and investigating a quality defect

5.1 Each certifying authority undertakes to institute enquiries into any quality defect reported in a product exported in accordance with the provisions of the Scheme, on the understanding that:

- the complaint is transmitted, together with the relevant facts, through the competent authority in the importing country;

- the complaint is considered to be of a serious nature by the latter authority; and

- the defect, if it appeared after delivery of the product into the importing country, is not attributable to local conditions.

5.2 In the case of obvious doubt, a participating national authority may request WHO to assist in identifying an independent quality control laboratory to carry out tests for the purposes of quality control.

5.3 Each certifying authority undertakes to inform WHO and, as far as is possible, all competent national authorities, of any serious hazard newly associated with a product exported under the provisions of the Scheme or of any criminal abuse of the Scheme directed, in particular, to the export of falsely labelled, spurious, counterfeited or substandard pharmaceutical products. On receipt of such notification, WHO will transmit the message immediately to the competent national authority in each Member State.

5.4 WHO stands prepared to offer advice should difficulty arise in implementing any aspect of the Scheme or in resolving a complaint, but it cannot be a party to any resulting litigation or arbitration.

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