Joining the WHO Programme

JOINING THE WHO PROGRAMME

Considering the sensitive nature of the data being collected within the Programme, countries contribut-ing 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 require-ments 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) and

·    technical competence to fulfil reporting require-ments to WHO. Case reports collected in the national drug monitoring programme must be submitted regularly to the WHO Programme in a defined format.

The UMC has published Safety Monitoring of Medici-nal Products: Guidelines for Setting-up and Running a Pharmacovigilance Centre (WHO and Uppsala Moni-toring Centre, 2000) and argues the case for good pharmacovigilance practice (Meyboom, 2000).

For further information please contact:

World Health Organisation

Health Technology and Pharmaceuticals CH-1211 Geneva 27 Switzerland

Telephone: +41 22 7912111

e-mail: couperm@who.int

WHO Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Centre)

Stora Torget 3

SE-753 20 Uppsala

Sweden

Telephone: +46 18 656060

e-mail: info@who-umc.org