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

Start with a Norwegian translation of the current version of the QRD template. Then add standard sentences where applicable based on guidelines, templates or appendices. Add mandatory text from referral and PSUSA updates. Furthermore, add text excerpts from PRAC signals. PRAC signales are not mandatory but highly recommended security updates.

For medicinal products approved in central procedure (CP)

If medicinal products are approved through a generic, biosimilar, hybrid or informed consent procedure, the Norwegian translation must be identical to the Norwegian product information of the original medicinal product. Note that this does not apply to the product-specific parts of the product information and if the original medicine has not been updated according to current templates and guidelines.

Renewals

The product information must be reviewed with focus on plain language and updates according to the QRD template and guidelines.

It is important to get an overview of the text and which parts of the text that need to be updated/made more understandable.

Check whether the text has correct sentences from the QRD template, excipients guideline etc. Also check whether the text contains mandatory texts from a referral or a PSUSA, or recommended text from a PRAC signal.

For generic/biosimilar medicinal products approved via a central procedure: see "How to write a good Norwegian product information".

Variations and notifications

Only text that corresponds to the requested variation, and if relevant to a variation in approved English (common) text, can be changed in the Norwegian product information. Check whether the variation are mandatory text (PSUSA, referral) or recommended text (PRAC) or standard sentences from the QRD template. 

For generic/biosimilar medicinal products approved via central procedure: see "How to write a good Norwegian product information"

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

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'. The link is found at the bottom of this page. 

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.

Readability testing

Readability of the PL shall be tested with a target group of patients to ensure that the PL is legible, clear and easy to use. Read more about readbility testing.