​​​​​​​​​​​​​​​​​Summary of product characteristics and Package leaflet

he target audience for the SmPC are healthcare professionals with medical professional background. The applicant must ensure that the SmPC is of high quality. The concept of plain language should be used.

How to write a good text:

1. Write in Norwegian

It is important that the translated Norwegian text has the same meaning as the English text (faithful translation). There are differences between English and Norwegian grammar. Sentence structure and word order are often different. Direct translation from English to Norwegian can lead to complicated wording and incorrect translation. Split long sentences if possible.

2. Write clearly

Use short sentences and write in an active voice. Avoid using extra nouns. Use verbs instead of nouns where possible. The message should not be disturbed by ambiguous and unclear language.

3. Write to healthcare professionals

Use well-established Norwegian medical terms as much as possible. Some medical terms are identical in English and Norwegian.

4. Standardised translations and abbreviations

The following translations should always be used in the SmPC.

Standardised translations:
active substance – virkestoff
adverse effects/adverse drug reactions – bivirkninger
adverse events – uheldige hendelser
drug/substance – legemiddel
efficacy/effectivity – effekt
herbal medicinal product – plantebasert legemiddel
medicinal product – legemiddel
patient alert card /patient reminder card – pasientkort

Abbreviations:
QD – én gang daglig
BID – to ganger daglig
TID – tre ganger daglig
QID – fire ganger daglig

Applicants must ensure that the package leaflet (PIL) always is of high quality. The target audience for the PIL is the patient, therefore the PIL should be easy to read and understand (written in plain language).

How to write a good text:

1. Write in Norwegian

It is important that the translated Norwegian text has the same meaning as the English text (faithful translation). There are differences between Norwegian and English grammar. Sentence structure and word order are often different. Direct translation from English to Norwegian can lead to complicated wording and incorrect translation. Split long sentences if possible.

2. Write clearly

Use short sentences and write in an active voice. Use verbs instead of nouns where possible. The message should not be disturbed by ambiguous and unclear language.

3. Write to the patient

Foreign words are used to a greater extent in the English language, than in Norwegian. Medical terms should always be translated into patient friendly terms and language. The medical term may in some cases be kept in brackets.

Excipients guideline with Norwegian translations

Excipients in medicinal products should be listed qualitatively in the package leaflet. Several of these should be accompanied by information that is of importance to the patient. Such excipients are listed in the Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'(External link) (pdf)

New MAs shall comply with this guideline. Existing MAs must update the package leaflet in the next variation concerning the product information or renewal procedure.