Reports from compassionate / named patient use
In the Netherlands, reports of suspected adverse reactions should be actively collected for medicinal products that are used within a compassionate use programme or a Doctor’s Declaration (named patient).
When, as a marketing authorisation holder or applicant for marketing authorisation, an adverse reaction to your medicinal product that is used within a ‘compassionate use programme’ has come to your knowledge, you must follow the guidelines in GVP Module VI. Reports suspected to be related to the medicinal product (as assessed by the primary reporter or by the applicant/authorisation holder) must be sent to EudraVigilance.
For medicinal products that are used based on a Doctor's Declaration, the reporting requirements as published on the website of the Health and Youth Care Inspectorate (IGJ) apply. The legal entity (i.e. a pharmacist, a general practitioner owning a pharmacy, a wholesale distributor or a manufacturer) that received permission from the IGJ to supply an unlicensed product under named patient use must report suspected ADRs to the Netherlands Pharmacovigilance Centre Lareb. This report must also be sent to the pharmaceutical company concerned. Lareb will forward all received ADRs to EudraVigilance. The legal entity that received permission from the IGJ to supply an unlicensed product under a named patient use or the pharmaceutical company concerned do not have to report these ADRs to EudraVigilance.