The warning triangle

All medicinal products for human use containing active substance(s) stated in the warning triangle list from the NoMA shall bear the warning triangle. For these medicinal products the warning triangle should be present/applied on the package. This also applies for parallell imported medicinal products and medicinal products that are solely used in hospitals.

Medicinal products that have MA, but are not marketed in Norway shall also be updated with the warning triangle.

Medicinal products with active substance(s) which are not on the warning triangle list shall not bear the warning triangle on the package. For these medicinal products the warning triangle must be removed from the package.

Veterinary medicinal products shall also not bear the warning triangle.

Even if the product information to the medicinal product states that the medicine affects the ability to drive, a warning triangle must not be applied on the package if the active substance is not on the warning triangle list. The requirement regarding the warning triangle is not connected to the information given in section 4.7 “Effects on ability to drive and use machines” of the SmPC and section 2 “Driving and using machines” of the PIL. The requirement regarding the warning triangle is connected to medicinal products falling under the categories listed in Annex 1, chapter 14 § 36 in the regulation of the driving license “førerkortforskriften”. 

Medicinal products containing active substance(s) included in the warning triangle list approved as of 01.07.2018 shall bear the warning triangle on the packaging. 

If the active substance(s) is not on the list, but is an active substance that can be considered to be in the group of benzodiazepines, opioids, antihistamines (1. generation) and substitution (LAR) treatment, the NoMA will inform you together with the granting of the marketing authorisation if the medicinal product shall bear the warning triangle.

It is still possible with a multilingual package even though the warning triangle is only required for one or more countries and not all the countries. 

For purely national procedure and the MRP/DCP the warning triangle on the multilingual packaging can be hidden by a sticker (see the Q&A to the Guideline on Nordic packages(External link).)

For centralised procedure the warning triangle is a Norwegian Blue box requirement. If there are different requirements in the countries included in the multilingual pack, several Blue boxes needs to be included on the package.

There are requirements regarding the design of the warning triangle. The warning triangle must appear as a red, isosceles triangle on a white background. The corners are pointed, with one of the corners pointing upwards. Minimum length of the sides is 10 mm (0.4 inches). The minimum width of the frame is approx. 2 mm (0.08 inches). The colour shall be signal red in colour code C: 0, M: 96, Y: 90 K: 2 (or similar).

MRP/ DCP and national procedure

The mock-ups can be updated in connection with a variation application which affects the mock-ups or a 61(3) notification for information only can be submitted, provided that the warning triangle is added or deleted and no other changes to the layout has been made.

CP

The warning triangle is added or removed without an approval of the Blue box content from the NoMA. It is the MAHs responsibility to ensure that the changes are implemented as required. Do not submit a variation application to the EMA or the NoMA.