reporting adverse events
Reporting adverse events leads to new understanding of the
effects of medicinal products that were not yet known when the
product received marketing authorisation. In the Netherlands, the
Netherlands Pharmacovigilance Centre Lareb collects reports from
doctors, pharmacists and patients. It performs this task on behalf
of the MEB.
Patients
Patients can report suspected adverse events to the Netherlands Pharmacovigilance Centre Lareb. This must
be done using an electronic form.
If you want to report any other kind of experience with a
medicinal product (not an adverse event), you can do this at the
website Medicinal
Products Reporting Unit of the Dutch Institute for the Proper
Use of Medicine (DGV). These experiences might include problems
with labelling or package leaflets, for instance.
Patients with questions about adverse events can contact the
Medicinal Products Hotline (Geneesmiddeleninformatielijn - only
available for people calling from the Netherlands) on 0900-9998800
or visit http://www.apotheek.nl/.
Healthcare providers
Healthcare providers are encouraged to report suspected adverse
events to the Netherlands Pharmacovigilance Centre Lareb. The
electronic Pharmacopoeia also
contains a link to the Lareb report form with each entry on a
medicinal product. Paper forms can be obtained from Lareb on
request.
Marketing authorisation holders
Marketing authorisation holders have a statutory obligation to
report adverse events to the MEB. There are detailed instructions
as to what has to be reported and how reports must be submitted,
check
'Expedited reporting requirements based on pharmacovigilance
legislation'.
Clinical trials with medicinal products
Sponsors of clinical trials with medicinal products are also
required to follow specific instructions for the submission of
reports, check
'Expedited reporting requirements based on clinical trials
legislation'.
As from 1 January 2010 all adverse events/reactions (SUSAR’s and
SAE's) from investigator initiated trials should be submitted via
the CCMO webportal
ToetsingOnline. The Adverse Event Reporting Module in
ToetsingOnline handles submission to the MEB, CCMO (or Minister, if
applicable) as well as the accredited Ethics Committees in the
Netherlands. SUSARs that have been submitted via ToetsingOnline do
not have to be submitted to the MEB again.
SUSARs orginating from the Netherlands, which have not yet been
submitted to the EMA EudraVigilance database will be re-routed to
the Netherlands Pharmacovigilance Center Lareb, who will take care
of submission to the EMA in line with ICH E2B(R2) requirements.
This Adverse Event Reporting Module in ToetsingOnline is
currently available for investigator initiated trials only. It is
expected that the CCMO will develop an Adverse Event Reporting
Module for commercial clinical trials in 2010.
For guidance with respect to the CCMO webportal ToetsingOnline,
as well as reporting requirements to CCMO and Ethics Committees you
are referred to the
CCMO website.
