Documents - Medicines

7 documents on Medicines

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  1. GLP domestic test facilities

    Publication | 07-05-2024

  2. GLP: Non-domestic test facilities

    Publication | 02-10-2023

  3. Template for Risk-Assessment Questionnaire Pharmacovigilance

    This template is to help marketing authorization holders (MAHs) during the collection of information from different departments ...

    Publication | 02-02-2023

  4. 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 ...

    Publication | 20-09-2022

  5. Requirements (re)start clinical trials

    Report | 25-08-2020

  6. Coronavirus (COVID-19): impact on the conduct of clinical trials under the Medical Research Involving Human Subjects Act (WMO)

    Publication | 25-08-2020

  7. 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 ...

    Publication | 02-08-2017