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​​​​​​​​​​​​​​​​​Summary of product characteristics (SmPC) and Package leaflet (PIL)

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    ​​​​​​​​​​​​​​​​​Summary of product characteristics (SmPC)

    The 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

    Package leaflet (PIL)

    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' (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.

    Blue box

    There is no longer a requirement for Blue box wording in the Norwegian PL's, starting February 12 2020. The MAH's should submit a variation to make sure that the text in the PL is adapted to their product.

    The change in Blue box standard wording shall be submitted as a type IB C.I.z or a type II variation that affects the product information. Type IA or a 61(3) notification are not applicable for this matter.

    MRP/DCP

    For MRP/DCP the Norwegian PL should be a faithful translation of the common text approved in the procedure, i.e. the purely national Blue box wording must be removed from the PL.

    National procedure

    Blue box wording under section 1 in the PL shall be removed.

    In cases where there is aneed to retain important content from the Blue box standard wording, the sentences should be reformulated with adjusted text in accordance withsection 4.7 and 4.9 in the SmPC, respectively:

    Information under ​"​Kjøring og bruk av maskiner"

    • Shall be adapted to each individual medicinal product

    Information under "Dersom du tar for mye av X"

    • Shall be adapted to each individual medicinal product
    • It is possible to refer to the NorwegianPoison InformationCentrewhen relevant to the medicinal product. If so, the existing Blue box wording can be kept.

    For nationally authorised products the proposed wording will be assessed by NoMA.

    The Blue box standard wording which was applicable until February 2020:

    • Legal status Under punkt 1: Hvis preparatet er unntatt fra reseptplikt må det fremgå av pakningsvedlegget. Tilhørende indikasjonsområde og dosering inkluderes.
    • Under punkt 1: "Vær oppmerksom på at legen kan ha foreskrevet legemidlet til en annen bruk og/eller med en annen dosering enn angitt i pakningsvedlegget. Følg alltid legens forskrivning som er angitt på apoteketiketten."
    • Under overskriften: Kjøring og bruk av maskiner: "Du må bare kjøre bil eller utføre risikofylt arbeid når det er trygt for deg. Legemidler kan påvirke din evne til å kjøre bil eller utføre risikofylt arbeid. Les informasjonen i pakningsvedlegget nøye. Er du i tvil må du snakke med lege eller apotek. "
    • Under overskriften: Dersom du tar for mye av X: "Kontakt lege, sykehus eller Giftinformasjonen (tlf. 22 59 13 00) hvis du har fått i deg for mye legemiddel eller hvis barn har fått i seg legemiddel ved et uhell. For andre spørsmål om legemidlet, kontakt lege eller apotek."

    High quality Norwegian product information

    The product information has to be easy to read and understand for the users. A higher quality of the product information will improve the patient information and contribute to safe use of medicines.

    This section will give you some advices on how to create a Norwegian product information of high quality. This includes information about the marketing authorisation holder (MAH) responsibilites, choice of translators, resources, high quality translations of new marketing authorisations (MA) and improving excisting product informations.

    Templates, guidelines and other resources on how to write a high quality Norwegian product information can be found under "Resources" further down on the page.

    MAH responsibilites

    The MAH is responsible for the product information and its high quality. The product information includes summary of product characteristics (SmPC), package leaflet (PL) and labelling .

    Adequate principles of plain language shall be applied. The MAH is responsible for ensuring that the Norwegian product information is updated in accordance with today's requirements and guidelines before submission.

    Resources

    The MAH should focus on readability, harmonised and consistent language when translating to Norwegian. Templates, reference and guidance documents that are instrumental for the preparation of a high quality product information are listed below (not exhaustive):

    For general reference guidelines on how to create a product information

    Terms that are approved/preferred for use

    Recommendations on updating the product information

    Contact us

    Unit for medicinal product information

    +47 22 89 77 00

    pi@noma.no