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Administrative fine

Under the Medicines Act, the Inspectorate is entitled to impose an 'administrative fine' in respect of any breach. This is a less stringent measure than disciplinary or criminal proceedings.

The Inspectorate may opt to impose a fine if, for example, the guidelines for preparation of medicines are not followed, if a product is offered for sale without the required marketing authorisation, or trials of a drug are conducted without the necessary licences and permits. The amount of the fine will depend on a number of factors, including the seriousness of the incident, the potential risk to public health, and the size of the company in question. Indicative tables of the fine amounts are to be found in the Policy Guidelines on Administrative Fines (Beleidsregels Bestuurlijke Boete) at www.overheid.wetten.nl.