Linguistic proofreading of product information for centrally authorised medicinal products
When a medicinal product is granted a marketing authorisation via the centralised procedure, the Danish Medicines Agency performs a linguistic proofreading of the Danish product information, which companies provide to doctors and patients, e.g. summaries of product characteristics, labelling and package leaflets.
The linguistic proofreading follows EU rules on supply and layout of product information and occurs as a continuous dialogue with the individual companies. The purpose of the linguistic proofreading is to ensure a high quality and consistent Danish language standard in the product information. You can find further information via the box to the right (Examples of poor translations are provided in Danish only).
As participants in the European cooperation within the area, one of the tasks is to draw up norms for layout and presentation of the product information. This cooperation is organised by EMA, where it is carried out by representatives from the EU member states in the Working Group on Quality Review of Documents (abbreviated QRD); please see the box to the right.
We proofread companies' product information with the expectation that it complies with the following standards:
- The standard headlines and standard texts at EMA's website are used; more information via the fact box to the right.
- The contents of the package leaflet are consistent with the summary of product characteristics.
- The Danish translation is a faithful translation of the original text.
- Choice of words and use of terminology is consistent.
- Summaries of product characteristics, package leaflets and labelling are in correct Danish.
- Phrasing and terminology are accommodated to the users, for example the package leaflets are always written in an easy-to-read language.
- The package leaflet only contains technical terms if the users know such words.
We may suggest changes to the translations supplied by the companies. The linguistic proofreading follows EMA's policy for the work of the QRD group.
If we experience numerous or serious cases of negligence of the above standards, we are entitled to request the company to supply us with a completely new translation. Normally, the new translation must be submitted within a week.