Requirements for labelling on packaging

Requirements for labelling of medicinal products are according to Regulation Nr. 462/2000 on marketing authorisations for proprietary medicinal products, their labelling and PILs

PILs and packaging, exemptions

In the case of medicinal products indicated for rare diseases, IMA can permit labelling and PILs to be in English or in a Nordic language other than Finnish. IMA can also grant an exemption from generally required information on the labelling or the PIL. Furthermore, exemptions can be granted for the PIL being in Icelandic if the product is not given directly to the patient for self-medication or owner/possessor of an animal in the case of a veterinary medicinal product.

(Source Directive 2001/83/EC art.63 (human medicinal products) and Directive 2001/82/EC, art.61 (veterinary medicinal products).)

Preliminary exemptions for packaging

In exceptional cases IMCA can grant provisional exemptions from approved packaging in order to alleviate shortage of specific medicinal products. Each case is individually assessed, but the following information must accompany each application:

The number of packages to be exempted must be specified or the time limit intended for the exemption. A mock-up for the intended packaging to be used while the product is not available in approved packaging. If the packaging does not have the same product ID (Nordic Number) as an approved packaging, the MAH must confirm the equivalence of the products.

National Requirements regarding labelling/package leaflet (Products authorised via MR, DC or national procedure) (About exemptions from the requirements, see above)

From Notice to Applicants, chapter 7:

... 10.   ‘blue-box’ requirements 

Additional information on labelling/package leaflet that may be required nationally in accordance with Articles 57 and 62 of Directive 2001/83/EC as amended, is outlined below.

These requirements apply to products authorised via a Mutual Recognition or Decentralised Procedure only. Blue-Box requirements for products authorised via the Centralised Procedure are detailed in the "Guideline on Packaging Information of medicinal products for human use authorised by the Community" as published in Volume 2C. 

Iceland

Package leaflet (PL)

Under the heading number 1

”Verið getur að læknirinn hafi ávísað lyfinu við öðrum sjúkdómi eða í öðrum skömmtum en tiltekið er í þessum fylgiseðli. Ávallt skal fylgja fyrirmælum læknis og leiðbeiningum á merkimiða frá lyfjabúð.”

English translation:  “Please notice that your doctor may have prescribed the medicinal product for a different therapeutic indication and/or at a different dosage that is stated in the package leaflet. Always follow the doctor’s prescription and the instructions on the pharmacy label”.

Under the heading ”If you <take>  <use> more X than you should”

“Ef of stór skammtur af lyfinu hefur verið notaður, eða ef barn hefur í ógáti tekið inn lyfið skal hafa samband við lækni, sjúkrahús eða eitrunarmiðstöð (sími 543 2222).”

English translation:   “Contact your doctor, the hospital or “eitrunarmiðstöð” (sími 543 2222)  if you have taken more X than you should or if children have been taking medicine by accident.”

Under the heading “Driving and using machines”

Lyf geta haft áhrif á hæfileikann til að aka bíl eða framkvæma áhættusöm verk vegna verkana sinna eða aukaverkana. Lesið vandlega upplýsingarnar í fylgiseðlinum. Hafið samband við lækni eða lyfjafræðing ef þörf er á frekari upplýsingum.

English translation:

Medicines may influence your capability to drive or carry out dangerous work.  Read the information provided in the package leaflet carefully.  Ask your doctor or pharmacy for advice if you are unsure. “

Label

Price

There is no requirement for the price to appear on the label.

Reimbursment

There are no reimbursement conditions to appear on the label.

Legal status

There is no requirement for the legal status to appear on the label except for packages intended  for dose dispensing.

• Þessi pakkning er eingöngu ætluð til skömmtunar.
• English translation:  For dose dispensing only

Identification and authenticity

The Nordic number required (exception:  radiopharmaceuticals)

Written as  “Vnr XX XX XX”.

Bar code is accepted

Symbol and pictogram

Products containing inflammable material must bear the international warning symbol

Eldfimt         English translation:  Inflammable + symbol

Products which reduce the ability to drive or operate machines must have a warning triangle.  The tip of the triangle points upwards. It is a red triangle on a white background.  Its size is adapted to fit the label; its sides are usually 10 mm long and the width of the frame is usually 2 mm.