14 August 2018 - Authored by: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 on Research Involving Human Subjects. Its task is to issue advice on legislation that is applicable to individual products, product groups or substances belonging to a group of so-called borderline products (that is, products with combined characteristics of foods, medicines, cosmetics and/or biocides, for which it is therefore unclear which regulations are applicable). The advisory group’s assessments do not involve the efficacy or safety of medicines or any research protocols.
The advisory group was established because it is not always clear which regulations apply to certain products (for example, in relation to research and marketing authorisation) and, as a consequence, which authority is competent to act and enforce the law. The Advisory Group will grant advice on the applicable legislation upon the request of one of the authorities involved. The authorities involved may then respond to the advice within four weeks after its presentation, after which the advisory group reconsiders and adjusts the advice if necessary. In the absence of a final agreement on the applicable legislation, no advice will be issued. The advisory group may also change its advice in the event of legislative changes. The advice issued, any lack of agreement on the applicable law, and amendments to any piece of advice will be registered on the advisory group’s database.
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, July 2018 Issue (Thomson Reuters).