The Netherlands

The Dutch Medicines Evaluation Board (MEB) published an update of the policy document (MEB 44) regarding Direct Healthcare Professional Communications (DHPCs). This policy presents a framework for the way in which the MEB deals with DHPCs and the considerations that are made when assessing them. Several practical topics are addressed: a single DHPC for multiple products, to what extent must a literal ENG>NL translation be used, electronic distribution of DHPCs, etc.

The single new topic in this update clarifies how to use personal data in the DHPC letter: after the Dutch translation of the DHPC has been established, the marketing authorisation holder (MAH) must immediately submit an anonymised version, dated but without personal data in Word format. This will be published on the MEB website. The version of the DHPC that will be sent out to the target group can include personal data.

Personal data are any information which are related to an identified or identifiable natural person. For example names and signatures, but also email addresses. If the name of a natural person can be identified from the email address, this email address is not allowed to be published on the MEB website. The MAH must therefore use an email address without personal data, for example department@organisation.tld or an abbreviation of the name. Within these examples, no natural person can be identified from the email addresses.


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