Reporting of adverse reactions - MRP/DCP and NP - human

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 legemiddelet er viktig. Det gjør det mulig å overvåke forholdet mellom nytte og risiko for legemiddelet 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 legemiddelet.

For medicinal products authorised through CP, the update concerning the name change will be handled in line with Appendix V(External link)(External link). 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

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(External link)(External link)(External link) (pdf)) within 2-3 years.

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

See information in annotated QRD template section 7.

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).

See information in annotated QRD template section 7.

For medicinal products authorised through CP, the update concerning the name change will be handled in line with Appendix I(External link)(External link). 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