Since the first of October the Dutch Medicines Agency CBG-MEB has changed its policy regarding distribution of Direct Healthcare Professional Communication (DHPC).
The DHPC is a one-off, additional risk minimisation measure used to directly inform healthcare providers about new, important risk information regarding a medicinal product. This is usually coordinated at European level and will then be decided by MEB on national level if the DHPC will also be sent in the Netherlands.
Until the first of October 2024 health care professionals received this information via post, more specifically in an envelope with an orange or white hand. This is to distinguish between very important or urgent DHPCs (orange hand) and other DHPCs (white hand). The colour of the hand is decided by the MEB in collaboration with the Health Care Youth Inspectorate (IGJ).
With the change in policy of the MEB, the marketing authorisation holders will need to send their DHPCs via e-mail to the health care professionals. This change will make sure that the important risk minimisation information will reach the target population much earlier than when sending it via post. Apart from the DHPC, the change to digital distribution also applies to recall letters.
The digital DHPCs will be send to the health care professionals who already received the DHPCs via post before, with the strong condition that an e-mail address is known. If you have never received the communication via post before, make sure to check the website of Vereniging Innovatieve Geneesmiddelen for more information on how to subscribe. In case an e-mail address is not known, health care professionals will still receive the DHPC per post as well after 1 October 2024.
Important to keep in mind is that other risk minimisation measures such as educational materials will not follow the digital distribution via e-mail but will still be sent via post.
For more information about this topic, please reach out to us via our Contact page.
