The warning triangle list comes into force on the 1.7.2018.
The purpose is to harmonise the warning triangle guidance and Annex 1, chapter 14 § 36 in the regulation of the driving license “førerkortforskriften”.
Implementation
The warning triangle must be implemented within 1.7.2019.
The purely 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 can be submitted, provided that the warning triangle is added or deleted and no other changes to the layout has been made.
The mutual recognition procedure: The mock-ups can be updated in connection with a variation application which affects the mock-ups or a national 61(3) notification for information can be submitted, provided that the warning triangle is added or deleted and no other changes to the layout has been made.
The centralised procedure: 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.
New medicinal products: Medicinal products containing active substance(s) included in the warning triangle list approved as of 1.7.2018 shall bear the warning triangle on the packaging. The NoMA will evaluate whether new active substances shall bear the warning triangle during the procedure.
The applications can be submitted to: pi@noma.no
Q&A
What is the intention of the warning triangle?
To inform you that you need to consider your ability to drive when you use a medicinal product. Talk to your doctor about whether your medicine(s) and disease/illness (?) effects your ability to drive.
When does the new practice take effect and what is the implementation time?
The new practice comes into force on the 1.7.2018. All medicinal products for human use must implement the warning triangle within 1.7.2018.
How do I know if the packaging of a medicinal product is covered by the guidance?
Look at the warning triangle list from the Norwegian Medicine Agency. If the active substance is stated in the list, the packaging of your medicinal product shall bear the warning triangle. If the active substance is not included in the list, the medicinal product shall not bear the warning triangle.
The packaging of a medicinal product bears the warning triangle, but the active substance is not included in the warning triangle list – what to do?
The warning triangle must be removed from the package. This change must be implemented within 1.7.2019.
The warning triangle on the packaging of a medicinal product must be removed. Do I apply for a variation – and if so, what type of variation shall be submitted?
For the purely national procedure: Yes. You can either update the mock-ups in connection with a variation application affecting the mock-ups, or submit a national 61(3) notification. The latter alternative is only applicable if the change solely affects the warning triangle.
The application can be submitted to: pi@noma.no.
For the mutual recognition/decentralised procedure: Yes. You can either update the mock-ups in connection with a variation application affecting the mock-ups, or submit a national 61(3) notification. The latter alternative is only applicable if the change solely affects the warning triangle.
The application can be submitted to: pi@noma.no.
For the centralised procedure: No. 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.
Will there be changes to the warning triangle list?
Yes. The list is updated whenever a new active substance, which will fall under the categories of a medicinal product listed in Annex 1, chapter 14, § - 36 in the regulation of the driving license “førerkortforskriften”, has been granted a marketing authorisation. The warning triangle list from the Norwegian Medicine Agency is updated accordingly and published on our website, www.noma.no.
Are there any requirements regarding the design of the warning triangle?
Yes. 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).
How to know if the packaging of a medicinal product shall bear the warning triangle when applying for a marketing authorisation?
If you find the active substance(s) on the warning triangle list, the packaging of the medicinal product shall bear the warning triangle.
If the active substance(s) is not on the list, but the active substance can be considered to fall under the following categories;
- 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.
The product information states that the medicinal product has influence on the ability to drive, but the active substance is not stated in the warning triangle list. Is the packaging of the medicinal product obliged to bear the warning triangle?
No. 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”.
Do packages not complying with the new practice need to be withdrawn from the market?
No. Packages placed on the marked before 1.7.2019 can remain on the marked until they are sold out or expired.
The medicinal product has a Norwegian marketing authorisation, but is currently not marketed. Do I need to update the labelling by 1.7.2019?
No. If your medicinal product is not marketed in Norway, the changes must be implemented by 1.7.2021 – given that it stays off the market. However, all medicinal products placed on the Norwegian marked after 1.7.2019, falling under the requirement to bear the warning triangle, must be updated accordingly before marketing.
Is the packaging of veterinary medicinal products covered by the guidance?
No. The requirement to bear the warning triangle is only applicable for medicinal products for human use.
What about parallel imported medicinal products, do they have to bear the warning triangle?
Yes. All human medicinal products containing active substances stated in the warning triangle list shall bear the warning triangle.
What about medicinal products solely for the use in hospitals. Are they exempted from the requirement to bear the warning triangle?
No. All packaging for human medicinal products are required to bear the warning triangle.
What about multilingual packaging? If the packaging of the medicinal product is required to bear the warning triangle in one or more countries, can I still have a multilingual pack?
Yes.
The purely national and the MRP procedures: The warning triangle on the multilingual packaging can be hidden by a sticker (see the Q&A to the
Guideline on Nordic packages.)
The 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.
If you cannot find the answer to your question above, please contact pi@noma.no.
