Netherlands

The Netherlands: New borderline products advisory group established

Iradj Nazaryar

On 9 July 2018, the establishment of the new Advisory Group on the Determination of the Status of Borderline Products was published in the Dutch Government Gazette. The Advisory Group consists of expert representatives from the Healthcare and Youth Inspectorate, the Dutch Food and Consumer Product Safety Authority, the Medicines Evaluation Board and the Central Committee Read More

Dutch government survey: “Are the supplementary protection mechanisms for pharmaceutical products fit for their purpose?”

Anna-Maria Withagen

Supplementary protection mechanisms have succeeded in achieving most of their aimed objectives, according to a study by the Technopolis Group that was commissioned by the Dutch government. However, another conclusion of the study is that the mechanisms seem to have various unintended effects as well. These effects still have to be further investigated. Below is Read More

Dutch Data Protection Agency issues guidance on large-scale data processing in healthcare

Iradj Nazaryar

Last month, the Data Protection Agency (DPA) issued guidance on large-scale healthcare data processing. The General Data Protection Regulation requires organisations involved in large-scale processing of data to appoint a Data Protection Officer (DPO) and in certain cases to conduct a Data Protection Impact Assessment (DPIA). In this respect, the guidance clarifies when healthcare providers are Read More

Amendment of the Dutch Code of Conduct for Pharmaceutical Advertising

Anna-Maria Withagen

On 1 July 2018, an amended Code of Conduct for Pharmaceutical Advertising (Code of Conduct) entered into force. The amendment follows a revised version of the policy rules providing guidance on the ban of inducements with regard to medicines, which entered into force on 1 April 2018 (see our previous blog post “Revised Dutch policy Read More

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