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  1. 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

  2. Notice to manufacturers nasal and mouth sprays

    The Health and Youth Care Inspectorate as market surveillance authority for medical devices in The Netherlands, would like to ...

    Letter | 14-11-2022

  3. GLP domestic test facilities

    Publication | 30-09-2022

  4. GLP: Non-domestic test facilities

    Publication | 30-09-2022

  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. IGJ assessment framework: Deployment of eHealth by healthcare providers

    The assessment framework in this booklet is the starting point for supervision by the Dutch Health and Youth Care Inspectorate ...

    Publication | 25-11-2021

  7. FAQ about inducements (Medical Devices Act)

    Report | 28-05-2021

  8. Guidance on the Management of Clinical Trial during the COVID-19 (Coronavirus) pandemic

    Due to the corona crisis the source data verification for the majority of the clinical trials conducted is severely hampered. ...

    Publication | 23-02-2021

  9. A: Relevant legislation

    Publication | 01-10-2020

  10. B: Clinical investigations involving the use of medical devices – regime

    Publication | 01-10-2020

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