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  1. GLP domestic test facilities

    Publication | 02-06-2025

  2. Inspections in the field of medicines, blood and tissues

    In the Netherlands, the Health and Youth Care Inspectorate (HYCI) is the supervisory authority for the quality, safety and ...

    Brochure | 21-02-2025

  3. GLP: Non-domestic test facilities

    Publication | 02-10-2023

  4. 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

  5. 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

  6. Requirements (re)start clinical trials

    Report | 25-08-2020

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

    Publication | 25-08-2020

  8. 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