In our newsletter of April 2017, the Bill for review of the Dutch Medicines Act2 (DMA) by reason of technical improvements and increase of the fine maximum was already discussed. The final Act3 was published on 15 November 2018 and entered into force on 1 January 20194.
One of the major changes is that the maximum legal level of the administrative fine for breaches of the entire DMA has been raised from EUR 450,000.= to no less but EUR 820,000.= in conformity with the Dutch Commodities Act5.
On 29 December 2018 the new Policy Rules for Administrative Fines have also entered into force6. Simultaneously, the Policy Rules for Administrative Fines 2017 have been withdrawn. In the new policy rules inter alia the validity of a warning has been set at two years.
1 Dutch Official Journal 2018, 469
2 Review of Dutch Act on Medicines by reason of technical improvements and increase of the fine maximum, Parliament, meeting year 2016-2017, 34 694, no. 2.
3 Dutch OJ 2018, 175
4 Dutch OJ 2018, 407
5 In conformity with the sixth category of Article 23 of the Dutch Criminal Code, i.e. presently EUR 820,000,=.
6 Dutch OJ (Staatscourant) 2018, 72501