The package leaflet has to be easy to read and understand for users. This page contains tips and resources for anyone who wants to work on creating an understandable Dutch language package leaflet. Is the Dutch package leaflet text a translation of an English text that has been approved in Europe? Even then the tips and resources can still be used.
The toolkit can therefore be used:
for products with a marketing authorisation obtained via the national, MRP/DCP or centralised procedure.
to make - parts of - an existing package leaflet more understandable, or when drawing up a new package leaflet text.
However, you should check whether the product is a generic product. Where possible you should then keep to the Dutch package leaflet of the reference product. If the package leaflet text of the reference product is not easy to understand, you should inform the marketing authorisation holder of the reference product in question.
If you have any questions or comments, please contact the Better Use Programme.
Toolkit for writing in an understandable way
Attend, for example, a course or workshop on understandable writing. This may help to see, from the reader's perspective, why writing in an understandable way is important. Practical guidelines are usually issued during most courses so that you can quickly put things into practice.
Mark which parts of the text you are not going to make more understandable. This may be two types of text:
Texts which come from the QRD template, Excipients guideline, etc.
Obligatory texts , for example from a Referral, PSUSA or a PRAC signal. Read more about where these obligatory texts are published.
First find a place for standard pieces of text, such as the current QRD template, Excipients guideline, etc. Then add obligatory pieces of text from a Referral, PSUSA or a PRAC signal in the package leaflet. Read more about where these obligatory texts are published.
Writing advice
Word plug-in (not free) which proposes understandable words
Digital tools such as ishetb1.nl to check whether words are sufficiently understandable
Reliable websites such as thuisarts.nl (for medical disorders) or apotheek.nl (for information about medicines) to see which terms they use.
The package leaflet must tie in with the text on which it is based:
A package leaflet is often a translation of an English language package leaflet text which has been approved in Europe (the 'common' package leaflet text). This text has to be taken into account.
The text in the package leaflet always has to be based on the information in the summary of product characteristics for the care provider (the SmPC). The package leaflet must therefore also be consistent with the SmPC.
Do not deviate from the message in the text. To make sure this does not happen, do not deviate too much from the sequence of information in the text.
Have someone else read through the text to see whether the information is understandable. The aim is to detect any possible problems. You could therefore ask future users, care providers or possibly one or more colleagues who may be able to help.
Use a digital tool (not free) to determine the quality level of the text.
Has the package leaflet been rewritten? If so, simply submit it to the MEB. So with a clear 'present'/'proposed' table. Also clearly indicate the basis for the changes. Study our example (available in Dutch).
An amended Dutch language package leaflet can be submitted via various types of procedures. A so-called Article 61(3) procedure is suitable if the package leaflet has been changed without any change to the summary of product characteristics for the care provider (the SmPC). Read more about the Article 61(3) procedure.
Textual changes to the package leaflet text can be made during a variation procedure (type II) in which the SmPC also changes.
In the event of numerous, or drastic, changes, you should contact the case manager/FT group in advance, or the Better Use Programme. You should do the same if you have any doubts about the right procedure for submitting the changes.
Submitting a package leaflet for a new product is part of the registration application. In that case the usual submission method will apply.
You have been given this medicine because you have COPD or asthma. Your illness means you have difficulty breathing. This medicine will help you to breathe more easily.
Instead of:
This medicine helps patients with chronic obstructive pulmonary diseases (COPD) or asthma to breathe more easily.
This medicine is intended for daily use.
Instead of:
This medicine is intended to be used as maintenance treatment for your chronic obstructive pulmonary disease (COPD) or asthma.
Do not use this medicine any more than 2 puffs 1 x per day.
Instead of:
Do not use this medicine any more than once a day (two inhalations each time).
