Article 61(3)-notifications and VRA G.I.15z (NP)

Article 61(3) Notifications regarding nationally approved medicinal products in Norway

Article 61(3) notifications are changes to the package leaflet (PIL) and/or the labelling not affecting the Summary of Product Characteristics (SmPC).

61(3) notifications for medicinal products authorized through the national procedure are submitted to pi@noma.no, with the filled in form attached.

Art 61(3) notification national procedure

Some changes to the labelling can be submitted for information only (in Norwegian). This applies to some 61(3)-notifications and the requirements for such notifications are listed in this document.

Veterinary products

For veterinary products changes to the package leaflet and/or the labelling not affecting the SmPC must be made by submitting a VRA G.I.15.z.

What is not considered a 61(3) notification?

​Corrections/updates to the Norwegian product information.

We encourage the applicant to include corrections to the SmPC/PIL as part of an ongoing or an upcoming procedure amending the product information (type I or type II).

Changes to the SmPC

An update of the SmPC to implement changes in the SmPC, not already covered by the classification guideline and for which no new data are required, should be submitted as a C.I.z, type IB variation (CMDh Q&A on variations). ​​

Important information regard​​ing MRP variation applications and art. 61(3) notifications

Please submit the SmPC/SPC, PL and labelling as separate Word files and use the latest version of the QRD templates.

Norwegian labelling text shall be submitted if there are changes in common labelling. Please submit mock-ups if there are significant changes in design or layout. Note that mock-ups must be in line with the current guidelines and that NoMA may request updated mock-ups when needed.