package leaflets

Package leaflets are derived from the Summary of Product Characteristics (SPC). They are intended for patients or consumers, and the medical terminology is translated into layman's language. Package leaflets are assessed and approved by the MEB.

The MEB publishes approved package leaflets (and other product information) in the medicine data bank.

If you are blind or have impaired sight, you can call the package leaflet hotline (only available for people calling from the Netherlands) on 0900 0125. The package leaflet text will then be read out to you.

The purpose of package leaflets is to improve information for patients and consumers, thereby promoting the responsible use of medicines.

Since 1994 it has been a legal requirement that all medicinal products (including those dispensed in hospitals and nursing homes) be supplied with a corresponding package leaflet.

Labelling
The MEB assesses the labelling text submitted by the company. Certain items must always appear on labels, such as the name of the medicinal product, the active ingredient, the strength and shelf life. Labels for products that are available without prescription (such as paracetamol) must also indicate what the medicinal product is for and when it must not be used.

New European legislation was adopted requiring the name of the product to be marked in Braille as well on labels for new medicinal products.

Package leaflets
Since 1994 it has been a legal requirement that all medicinal products (including those dispensed in hospitals) be supplied with a corresponding package leaflet. The aim is to improve information for patients and consumers, and thereby promote the safe use of medicinal products.

The MEB adds new and revised package leaflets to the Medicines data bank, which is accessible to everyone.
If you are blind or have impaired sight, you can call the package leaflet hotline (only available for people calling from the Netherlands) on 0900 0125. The package leaflet text will then be read out to you.

Readability of package leaflets
In collaboration with various interest groups, the MEB is working to improve product information products for patients. http://www.debegrijpelijkebijsluiter.nl/ provides information about these initiatives.

Legislation
For more information about requirements for labelling and package leaflets of pharmaceutical products, please go to Human medicines/Regulatory affairs/Package leaflets, SPC and labelling.