Why is this important?

European regulations require that all product information, including package leaflets, should be updated no later than three years of the latest QRD revision. However, the product information for many medicinal products on the Norwegian market still contain outdated information.

Update the Product Information according to QRD on Time

QRD templates are updated regularly to ensure clear, accurate, and harmonised information about medicinal products. The changes may be minor or significant, but they must be implemented in the product information as soon as possible and no later than three years after the update. This applies to both CP, MRP/DCP and nationally authorised medicinal products.

Remove Outdated “Blue Box” Sentences

Previously, Norway required certain standard sentences («blue box») to be included in the package leaflets. This requirement ceased in February 2020, yet many package leaflets still contain these sentences. Authorities are considering stricter enforcement for removal of these sentences in the future and strongly recommend pharmaceutical companies to proactively update their package leaflets.

How Can Mericon Help?

Mericon has extensive experience in updating product information, including package leaflets. We focus on consistent, harmonised and patient-friendly language.

 We can support with:

• Updating according to the latest version of QRD
• Removing “blue box” sentences
• Quality assurance of product information

Contact Us for Assistance

Don’t wait until the last minute—ensure your product information is updated in compliance with current regulations. Need assistance with the process? Contact us today for a non-binding consultation!

For further information, contact us!