The Norwegian Medical Products Agency (NOMA) recommends the use of digital package leaflets. 

All medicinal products have package leaflets with important information about correct use. In Norway, these leaflets are also available digitally on the website of The Norwegian Pharmaceutical Product Compendium, Felleskatalogen.no. 

There are many advantages with digital package leaflets:

Up to date information
Currently, inclusion of package leaflets in paper format in local language in Norway and EU is a legal requirement. However, there are limitations with package leaflets on paper, e.g. its time consuming and expensive to update, print, pack and distribute them.

The most important benefits with digital package leaflets from patients’ perspective is that the product information is always available online and up to date. This is also in the interest of the pharmaceutical industry, healthcare professionals and the authorities from a drug safety perspective.

Easily available information
Digital information in Felleskatalogen is easily available for patients via internet in a mobile application or pc. In addition to the packages leaflet the patient will also find other relevant information of the medicinal product in Felleskatalogen (The Norwegian Pharmaceutical Product Compendium), e.g. user instructions/videos. Prescriber information is also available here, e.g. FK text (short form of SPC), SmPC and additional risk minimisation materials (aRMM). The digital package leaflets on the Felleskatalogens web site are customised for patients with certain disabilities (e.g. voiceover, zoom/text size).

European cooperation
An ongoing European cooperation aims to introduce digital package leaflets. NOMA wants Norway to lead the way replacing paper with digital package leaflets. Currently, drug shortage is a problem in many countries in Europe and many medicinal products intended for use in small patient groups or countries with small populations do not reach the market. Facilitating use of common packages with reference to digital available information will ease market access for these medicinal products.

Environmental benefits
Let’s not forget the environmental perspective: Replacing paper package leaflets with electronic PILs will reduce paper usage and save manufacturing and transport energy, contributing to a more sustainable future.

Mericon supports pharmaceutical companies with regulatory services, including Felleskatalogen.
 Do not hesitate to contact us if you need support.

Referanser:

• Benefits and challenges of electronic package leaflet (ePL)
• Use digital package leaflets – Norwegian Medical Products Agency (dmp.no)

Foto: Istockphoto/Santje09