Medicine’s product information texts – what happens after regulatory approval?

A medicine’s product information (summary of product characteristics, package leaflet and labelling) contains essential information that healthcare professionals and patients using the medicine need to know about its use. The summary of product characteristics (SmPC) describes how the efficacy and safety of the medicine have been demonstrated and explains what the medicine is used for and how. The package leaflet (PL) is based on the SmPC and contains important information for the user about the correct use of the medicine. The package leaflet is part of the medicine pack. 

The product information is updated every time new information about the product becomes available, for example when updated information about the medicine’s efficacy and safety is obtained or when there are changes to the appearance or stability of the medicine. The newer the product, the more often the information needs to be updated. Once updates to the SmPC and PL have been approved by the authorities, the pharmaceutical company still has a lot of work to do to make the updated information available to patients and health care professionals.

Our experts have compiled a list of things that you may need to remember after the approval of a variation requiring changes to the product information:

• Within the pharmaceutical company, any changes must be communicated to different units and internal databases must be updated to make the latest product information available to everyone.
• The work of updating the labelling and the package leaflet, i.e. the artwork update, should be started in the company’s systems in order to get the changes implemented in the packaging materials. Implementation times vary between the Nordic countries. It is worth noting that, for multi-country packages, the Swedish six-month implementation period often determines the package material implementation schedule.
• During the artwork update phase, checks are carried out to ensure that the packaging materials have been updated correctly and that the user of the medicine will receive the necessary information in a format that is easy to read. Sometimes several rounds of corrections are needed before the most user-friendly result is reached.
• If changes have been made to the SmPC, the abbreviated SmPC and marketing materials may need to be updated. The abbreviated SmPC is used in marketing materials and contains the most essential information about the correct use of the medicinal product. The actual promotional materials must be prepared in accordance with the relevant legislation and Pharma Industry Finland’s Code of Ethics. 
• Sometimes the RMP (the product-specific risk minimisation material) is updated in connection with a text update, in which case it is necessary to review whether the change affects the additional risk minimisation materials. The updated materials and distribution plan may need to be submitted to the authorities.
• The Vnr number may also change in connection with a text update (e.g. transfers of marketing authorisations to new holders and withdrawals of marketing authorisations).
• After the product information is updated, it is important to ensure that the new texts are uploaded to the national pharmaceutical databases (Pharmaca, Lääkeohje, FASS, Felleskatalogen, DKMA.net) in order to provide healthcare personnel and other users with the information they need in a convenient manner.
• Other national databases may also need to be updated. In Finland, for example, a notification of introduction to the market must be filed through the Vnr web service if the composition or trade name of a product changes. 

Every year, our team of marketing authorisation experts helps numerous pharmaceutical companies with all things related to marketing authorisations for both human and veterinary medicinal products. We can give you a hand even at short notice, without compromising on quality. Please contact us for further information!