Documents - Medicines
7 documents on Medicines
GLP domestic test facilities
GLP: Non-domestic test facilities
Template for Risk-Assessment Questionnaire Pharmacovigilance
This template is to help marketing authorization holders (MAHs) during the collection of information from different departments ...
Restrictions in IGJ on-site inspections due to safety risks
During national or international crises, on-site GxP inspections may not be possible for a number of reasons such as travel ...
Requirements (re)start clinical trials
Coronavirus (COVID-19): impact on the conduct of clinical trials under the Medical Research Involving Human Subjects Act (WMO)
FAQ risk-based pharmacovigilance questionnaire
In order to effectively monitor the compliance of Dutch MAHs’ with the Dutch and EU legislation, the Inspectorate has developed a ...