Joining the WHO Programme

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Chapter: Pharmacovigilance: WHO Programme - Global Monitoring

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.


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

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