Medicines may only be marketed in Iceland once a marketing authorisation has been granted by the Icelandic Medicines Agency (IMA). The marketing authorisation holder decides whether a medicine that has been granted a marketing authorisation is subsequently marketed.

Withdrawal of marketing authorisation and removal from medicinal product registers

Withdrawal of a marketing authorisation means that the authorisation ceases to be valid and the medicine concerned may no longer be marketed. Removal from medicinal product registers, however, means that information about the medicine is removed from the registers and the medicine is no longer available, even though its marketing authorisation remains valid. Withdrawal of a marketing authorisation and removal from medicinal product registers may also apply to individual pharmaceutical forms, strengths, packaging types and pack sizes.

Reasons for withdrawal of a marketing authorisation

The main reason for withdrawing a marketing authorisation or removing information about a medicine from medicinal product registers is low sales. In such cases, this is done at the initiative of the marketing authorisation holder. This often creates difficulties for doctors and patients, and IMA therefore strongly encourages medicines to remain on the market for as long as they are needed. If a request to withdraw a marketing authorisation is due to low sales but there is considered to be a significant need for the medicine, IMA seeks an appropriate solution, for example by reducing fees relating to the medicine or approaching other pharmaceutical manufacturers about marketing an equivalent medicine in Iceland.

Various other reasons may lead to the withdrawal of a marketing authorisation or the removal of information about a medicine from medicinal product registers. The medicine may be unavailable because production has ceased, difficulties have arisen in manufacturing or transporting it to Iceland, or the assessment of its safety has changed.

Three months’ notice

IMA receives applications to withdraw marketing authorisations or remove information from medicinal product registers with varying periods of notice. Sometimes these requests arrive many months before the medicine becomes unavailable, but sometimes they arrive without notice or even after stocks in Iceland have run out. IMA has therefore asked pharmaceutical companies to submit such applications at least three months in advance.

Stocks of medicines that no longer have a marketing authorisation

If a marketing authorisation is withdrawn or information is removed from medicinal product registers for reasons other than safety, the general rule is that the medicine may be sold while stocks last, but for no longer than three months from the date of withdrawal or removal.

News items published where appropriate

In certain cases, IMA publishes a news item on its website announcing that a medicine’s marketing authorisation is being withdrawn or that a medicine is being taken off the market. This applies particularly where the medicine’s unavailability is expected to cause considerable inconvenience, for example where patients need to start taking a different medicine, or where significant use is anticipated of a medicine that will only be available under a special exemption granted by IMA. An exemption is granted at a doctor’s request for each patient concerned and/or for use in a healthcare institution (unlicensed medicines). Exemptions are not expected to be granted for prescribing medicines whose marketing authorisations are no longer valid or which are no longer marketed if medicines marketed in Iceland can be used instead.