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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