Changes to product information must be made more quickly

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 Medicines Evaluation Board (MEB). For that reason the MEB is stressing the need for the responsible pharmaceutical companies, or the market authorisation 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 authorisation 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 MEB is asking market authorisation holders to check their product information continuously and to submit a variation for a particular medicinal product wherever necessary. A general overview of sources in which the agreed wording is published can be found on the Implementation of agreed wording page of the MEB website.

Examples of recent agreed wording

In recent years a number of procedures have been completed whereby the wording has been amended for a large number of medicinal products. Some examples are the Article 31 referral procedures for fluoroquinolones, inhaled corticosteroids for chronic obstructive pulmonary disease and a PRAC recommendation relating to signals for hydrochlorothiazide and paracetamol.