QRD templates

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.

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

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

For medicinal products authorised through CP the texts below shall be included in the printed version of the product information only.

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 Statens legemiddelverk: www.legemiddelverket.no/meldeskjema.

Package leaflet 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 Statens legemiddelverk: www.legemiddelverket.no/pasientmelding. Ved å melde fra om bivirkninger bidrar du med informasjon om sikkerheten ved bruk av dette legemidlet.