Changes to product information must be made more quickly, says Dutch MEB

Within Europe agreements are regularly made regarding changes to information on medicinal products.

In many cases it takes too long before the changes have been implemented in the package leaflet, the product information for care providers and on the packaging. That is the conclusion of the Netherlands Medicines Evaluation Board (MEB). For that reason, the MEB is stressing the need for the responsible pharmaceutical companies, or the market authorization holders, to change their product information more quickly.

“The MEB keeps a record of those medicinal products for which amended wording has been agreed in a referral or a periodic safety update report single assessment (PSUSA) and checks whether the market authorization holder has or has not submitted a variation. Experience has taught us that in the case of a large number of medicinal products which are subject to such changes, the product information in question will not yet have been changed,” the Board said in a website posting.