Sunshine Act – disclosure

Sunshine Act – disclosure

Belgium On June 30, the transfers of value from the pharmaceutical and medical device industry to the healthcare industry have been disclosed on betransparent.be. This is already the third disclosure of collaborations under the legal framework of the Sunshine Act. A...
New Deadline for Risk Assessment on Nitrosamines

New Deadline for Risk Assessment on Nitrosamines

Europe Marketing authorisation holders (MAHs) are asked to take precautionary measures to mitigate the risk of nitrosamine formation or presence during the manufacture of all medicines containing chemically synthesised active substances. The MAHs were obliged to...
Closure of the MEB Portal

Closure of the MEB Portal

The Netherlands For safety reasons, the Medicines Evaluation Board portal was provisionally taken offline in January this year and unfortunately the MEB made the decision to close down the portal permanently. Due to the closure of the portal, the following services...
Amended policy on DHPCs: addition of photos

Amended policy on DHPCs: addition of photos

The Netherlands The Medicines Evaluation Board (MEB) has amended its policy on Direct Healthcare Professional Communications (DHPCs) for medicinal products for human use. The update includes the following: “The marketing authorisation holder must attach one (or more)...