Within Europe, the MEB and other European and national medicine authorities regularly make agreements about amending the product information for medicinal products.
Marketing authorisation holders must ensure that their product information is up to date (See Article 23.3 of European Directive 2001/83/EC). They are responsible for keeping up to date with relevant sources of new information and recommendations. The website of the European decision-making body CMDh features an overview of European agreements and EU agreed wording about amendments of the product information.
There are many different types of procedures. These procedures can result in different amendments of the product information. Recommendations from the European Pharmacovigilance Risk Assessment Committee (PRAC) and referral procedures, such as an Article 31 referral, are examples of this. For more information about these procedures, you can visit our website. The CMDh website has a complete overview of the procedures and recommendations.
Marketing authorisation holders must implement agreed wording in the product information. This is done by means of a variation procedure. For more information, read the Procedural Guidance: Variation Procedure on the CMDh website.
For a number of procedures, a timetable is determined at the European level. This timetable, depending on the type of procedure, can be found on the CMDh or EMA website. The MEB subsequently, after some time, determines whether the marketing authorisation holder has actually amended the text. If it has failed to do so, the MEB will request the marketing authorisation holder to include the stipulated text in the product information.
Dutch translations of agreed wording stipulated by the CMDh
Sometimes, the CMDh stipulates a single SmPC or patient information leaflet text for a group of medicinal products. To facilitate harmonised implementation, the MEB has published Dutch versions of some of these texts.
- Gecombineerde hormonale anticonceptiva die ethinylestradiol bevatten: Nederlandse vertaling SmPC en patiëntenbijsluiter (CHCs containing ethinylestradiol: Dutch translation of SmPC and patient information leaflet) (25 January 2017)
- NSAID’s voor systemische toediening en gebruik tijdens zwangerschap (NSAID-containing medicinal products (for systemic use) and use during pregnancy) (September 2022)
MEB decisions about adjustments to texts are usually adopted in a European context. If the marketing authorisation holder only needs to amend the product information in Dutch, MEB will inform the relevant marketing authorisation holders.