At the end of April 2018, the Dutch House of Representatives adopted a legislative proposal to amend the Dutch Medicines Act (DMA). The Bill increases the maximum statutory amount for administrative fines for violations of the DMA, currently set at EUR 450,000, to the amount determined for the sixth category in Article 23 of the Dutch Criminal Code, which is EUR 830,000 (Article 101(1) DMA) with the aim at strengthening the deterring effect of the fine.

In addition, the Bill incorporates material changes and technical improvements to the DMA, notably:

  • The prohibition on the unauthorised wholesaling of generators of radionuclides, kits, starting materials for radiopharmaceuticals and industrially prepared radiopharmaceuticals (Article 18(1) DMA).
  • Manufacturers will be able to acquire dispensation from the Healthcare and Youth Inspectorate to bring medicines inside the Dutch territory through other ways than by import (Article 18(6)(b) DMA).
  • The obligation to obtain a marketing authorisation prior to the offering of medicines for sale (including through the internet) or exporting medicines (Article 40(2) DMA).
  • The prohibition on the offering for sale and handing over of so-called UR, UA and UAD medicines (i.e. medicines that are available only on prescription, only at pharmacies, and only at pharmacies and drugstores respectively) is clarified to also cover online sales (Article 61(1), 62(1) and 67a DMA).
  • The Healthcare and Youth Inspectorate will be empowered to confiscate medicines or active substances immediately to prevent damage to public health (Article 115(1) DMA).

On 22 May 2018, the Dutch Senate formally adopted the bill, therefore paving the way for it to become law in the near future.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, May 2018 Issue (Thomson Reuters).