Essential medicines and health products

Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce

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.