To marketing authorisation holders - Mock-ups of packaging material including package leaflets

As of 24 January 2012 the Icelandic Medicines Agency (IMA) would like to receive final mock-ups of packaging material and package leaflets by e-mail

23.1.2012

As of 24 January 2012 the Icelandic Medicines Agency (IMA) would like to receive final mock-ups of packaging material and package leaflets by e-mail to mockups@ima.is. The same holds for stickers and package leaflets used for repackaging.

The e-mail should contain the following information:

  • Product name, strength, pharmaceutical form, pack size, packaging type and Nordic Article Number (Vnr).
  • Reference to IMA‘s V-number (if relevant) or the marketing authorisation holder‘s application.
  • Article number of the mock-up and reference to the type of material (carton, label, blister, package leaflet etc.).
  • Changes compared to last mock-ups, i.e. if there is no reference to a V-number.

If the mock-ups are submitted by e-mail no hard copies are required nor a formal letter by mail to the IMA.

The IMA plans to confirm receipt of mock-ups by e-mail.