|Counterfeit drugs (WHO/EDM, 1999, 61 p.)|
In considering measures against counterfeit drugs, emphasis should be given to the following:
The establishment of an adequate national drug regulatory system - an essential starting point. The system should include licensing/authorization of pharmaceutical products. It should also cover licensing/authorization of manufacturing, importation and distribution practices and premises and adequate inspection arrangements. It is the responsibility of governments to ensure that counterfeit drugs are taken off the market, and their sources found and eradicated. This should be a part of their overall quality control system.
Shared responsibility among the relevant parties. At the national level any difficulties and inefficiencies should be overcome by cooperation between the government agencies concerned and also with other involved groups. At the international level Member States, WHO, other United Nations organizations, nongovernmental organizations and other interested bodies should collaborate in the detection and prevention of counterfeit drugs. In this context, the liaison officers for the anticounterfeit pharmaceuticals network should be utilized to ensure timely exchange of information.
Sharing of information on counterfeit drugs with other countries and WHO. Where counterfeit drugs present the risk of serious health consequences, such information should be urgently and widely disseminated, in particular to the DRAs concerned.
Adequate training by government of the personnel of the national DRA and other relevant agencies involved in detection of counterfeit drugs.
Use of the measures and tools presented in these guidelines - by government and related parties to further combat counterfeit drugs.