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QRD templates

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  • : New information regarding implementation concerning our name change for human and veterinary medicinal products

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    QRD templates

    Norwegian QRD product information templates for all procedures for both human and veterinary medicinal products can be found on the Norwegian version of this page.

    Human

    Updating Norwegian product information by new QRD template

    Common practice for updating the product information of nationally authorised medicinal products (MRP/DCP and purely national procedure):

    • The product information should be updated according to the current template at the time of submission, i.e. applications submitted before the new template was published are processed according to the old template. If not other is advised by Reference member state (RMS) or national authority.
    • The product information should be updated with the next variation that affect the product information.
    • If no variation concerning the product information is planned, the MA-holder may submit a C.I.z, typeIB variation (CMDh Q&A on variations (pdf)) within 2-3 years.

    For medicinal products authorised through centralized procedures, please see EMA's website.

    Revision of Human QRD template – Version 10.1, 06/2019

    Version 10.1, 06/2019 of the human QRD template was published on the EMA's website on 28 June, 2019.

    Among the changes, new requirements for the traceability of biological medicinal products has been introduced under section 4.4 Warnings and precautions.

    Please note that in addition some linguistics updates have been made in the Norwegian translation.

    For detailed information on the implementation of the new version, see EMA's website.

    Reporting of adverse reactions in SmPC and PIL

    MRP/DCP and NP

    Concerning the name change, the reference to Direktoratet for medisinske produkter (DMP)/the Norwegian Medical Products Agency (NoMA) in the product information must be updated (see standard texts below). There is no deadline for the update, but please update with the first variation that affects both the SmPC and the PL. The update can be handled through a type IA, IB or a type II variation (not via a 61(3) notification).

    For medicinal products authorised through MRP/DCP and NP the texts below shall be included in both printed and electronic version of the product information.

    SmPC: Reporting of suspected adverse reactions (section 4.8)

    Melding av mistenkte bivirkninger

    Melding av mistenkte bivirkninger etter godkjenning av legemidlet er viktig. Det gjør det mulig å overvåke forholdet mellom nytte og risiko for legemidlet kontinuerlig. Helsepersonell oppfordres til å melde enhver mistenkt bivirkning. Dette gjøres via meldeskjema som finnes på nettsiden til Direktoratet for medisinske produkter: www.dmp.no/meldeskjema.

    PL: Reporting of side effects (section 4)

    Melding av bivirkninger

    Kontakt <lege> <eller><,> <apotek> <eller sykepleier> dersom du opplever bivirkninger. Dette gjelder også bivirkninger som ikke er nevnt i pakningsvedlegget. Du kan også melde fra om bivirkninger direkte via meldeskjema som finnes på nettsiden til Direktoratet for medisinske produkter: www.dmp.no/pasientmelding. Ved å melde fra om bivirkninger bidrar du med informasjon om sikkerheten ved bruk av dette legemidlet.

    CP

    For medicinal products authorised through CP, the update concerning the name change will be handled in line with Appendix V. Please note, from 01.01.2024 the new address must be inserted into the printed package by the Marketing Authorisation Holder. This does not require any variation application.

    New content in Appendix V:

    Norge: Direktoratet for medisinske produkter
    [For SmPC]
    Nettside: www.dmp.no/meldeskjema

    [For package leaflet]
    Nettside: www.dmp.no/pasientmelding

    Veterinary

    Reporting of adverse reactions

    See information in annotated QRD template section 7.

    MRP/DCP and NP

    Concerning the name change, the reference to Direktoratet for medisinske produkter (DMP)/the Norwegian Medical Products Agency (NoMA) (which was introduced in QRD template version 9) must be updated in the package leaflet. There is no deadline for the update, but please update with the first variation requiring assessment (VRA) that affects the package leaflet. The update can also be submitted through a variation not requiring assessment (VNRA) C.10b).

    CP

    For medicinal products authorised through CP, the update concerning the name change will be handled in line with Appendix I. Please note, from 01.01.2024 the new address must be inserted into the printed package by the MAH. This does not require any variation application.

    New content in Appendix I:

    Norge

    Direktoratet for medisinske produkter:

    www.dmp.no/bivirkningsmelding-vet