Enforcement term after change in legal status of supply

With an amendment of the legal status of supply of a medicinal product (including over-the-counter medicines), the Dutch Health and Youth Care Inspectorate (IGJ) gives manufacturers, wholesalers, pharmacies and chemists a maximum of twelve months’ time to bring practice in line with the changed status.

After 12 months the IGJ will enforce the legal status of supply. The enforcement term is necessary because:

  • manufacturers cannot change the labelling of medicinal products they manufacture immediately
  • there may be 'old' stock with the wholesalers or retailers

The enforcement term is a general principle which may be deviated from in special cases. For example, this would be the case when it becomes necessary from a public health point of view to enforce the legal status of supply with immediate effect.