Considering the sensitive nature of the data being collected within the Programme, countries contributing such data to the scheme have agreed on certain requirements that should be complied with by countries wishing to join. Collaborating with WHO, being an organisation for co-operation between member states, also requires a certain administrative structure of the drug monitoring activity. The basic requirements are:
* General acquaintance with the methodology of spontaneous monitoring. A country joining the
WHO Programme must have a programme for collection of spontaneous adverse reaction reports in place.
* A national centre for pharmacovigilance must be designated and recognised by the Ministry of Health (or equivalent).
* Technical competence to fulfill reporting requirements to WHO. Case reports collected in the national drug monitoring programme must be submitted to the WHO Programme in a defined format.
The UMC has published Safety Monitoring of Medicinal Products: Guidelines for Setting-up and Running a Pharmacovigilance Centre (WHO and Uppsala Monitoring Centre, 2000) and argues the case for good pharmacovigilance practice (Mey-boom, 2000).
For further information please contact:
World Health Organisation
Health Technology and Pharmaceuticals
CH-1211 Geneva 27
Switzerland telephone +41-22 7912111 telefax +41-22 7910746 e-mail [email protected]
WHO Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Centre) Stora Torget 3 S-753 20 Uppsala Sweden telephone +46-18 656060 telefax +46-18 656080 e-mail [email protected]
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