Netherlands

Dutch Parliament adopts bill to amend Medicines Act

Iradj Nazaryar

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 Read More

Dutch Data Protection Authority clarifies application of GDPR’s right to be forgotten and data portability to medical records

Iradj Nazaryar

The Dutch Data Protection Authority (DPA) recently published information on its website with respect to the application of the right to be forgotten and data portability to medical records under the General Data Protection Regulation ((EU) 2016/679) (GDPR). According to the DPA, the right to data portability applies only to the personal data that the Read More

Dutch CCMO publishes information on impact of GDPR on clinical research

Iradj Nazaryar

On 13 April 2018, the Dutch Central Committee on Research Involving Human Subjects (CCMO) published a Q&A on the impact of the upcoming General Data Protection Regulation ((EU) 2016/679) (GDPR) on clinical research. According to the CCMO, to process the personal data of current or past participants of research that comes under the Dutch Clinical Read More

Revised Dutch policy rules on inducement prohibition regarding medicinal products enter into force

Iradj Nazaryar

On 1 April 2018, revised policy rules concerning the inducements prohibition with regard to medicines (“Beleidsregels Gunstbetoon Gnw 2018“) entered into force. These policy rules provide guidance on what qualifies as an “inducement” and the scope of the prohibition. The new policy rules revise the previous version dating back to 1 May 2014 in light Read More

Dutch cabinet approves proposal for reimbursement of replacement medicines

Iradj Nazaryar

On 9 February 2018, the Dutch government issued a press release announcing the Council of Ministers’ approval of a proposal for the reimbursement of medicines from abroad that are not (yet) registered in the Netherlands (i.e., replacement medicines). In case of any shortage of a certain medicinal product in the Netherlands, an equivalent medicine approved Read More