Electronic submission of SPC/PIL – national procedure

Applications regarding national variations and renewals should include electronic version of the summary of product characteristics (SPC) and the package information leaflet (PIL)

This information concerns only variations and renewals in the national procedure for human and veterinary use. For other applications/procedures there are no changes in the existing routine.

What should be sent to NoMA?

A hardcopy of the application must be submitted by mail as earlier. Summary of product characteristics (SPC) and package information leaflet (PIL) should be sent in a hardcopy format, in addition to two separate electronic files of the SPC and PIL on a CD (in word-format). The files should not be placed in folders or zipped. The application form and other corresponding documentation can be sent on the same CD.

Tracking the variations in SPC and PIL
All variations in the SPC and PIL should be tracked in the word-document with the Track-Changes function

Template

SPC and PIL should follow EMEAs qrd-templates. See conventions to be followed for the EMEA-qrd templates.  ere.

Formatting the electronic files

In order to place the the SPCs in NoMA´s database, which is in HTML format, the SPCs need to be transferred manually into the database. To simplify this transfer of the Word-files, it is very important that the files are formatted in a unified way. Please follow the instructions related to the following Word-file formatting code when transmitting the SPC and PIL.

Contact:

Sissel Woxholt, Head of section for Regulatory Affairs
Sissel.woxholt@noma.no

Cecilie Kjorholt, Scientific officer
Cecilie.kjorholt@noma.no

Sist gjennomgått: 09.11.2011
Første gang publisert: 31.03.2008