Icelandic Medicines Agency
Withdrawal of marketing authorisations and removal from the medicines registers
Withdrawal of a marketing authorisation means that the marketing authorisation is cancelled, and it is therefore no longer permitted to place the medicinal product concerned on the market. Removal from the registers of medicinal products, on the other hand, means that information on the medicinal product is removed from the registers of medicinal products, and the medicinal product is therefore no longer available even though its marketing authorisation remains valid.
Requesting withdrawal of a marketing authorisation or removal of information from the registers of medicinal products
Please note the following when requesting withdrawal of a marketing authorisation or removal of information from the registers of medicinal products:
Applications for withdrawal of a marketing authorisation or removal of information from the registers of medicinal products shall be sent to the Icelandic Medicines Agency (IMA) on the application form, by email to afskraningar@lyfjastofnun.is.
For medicinal products on the market, the effective date is the first day of each month.
Applications for withdrawal of a marketing authorisation or removal of information from the registers of medicinal products must be submitted at least two months before the requested effective date.
If an application is made for withdrawal of a marketing authorisation and the applicant is not the marketing authorisation holder, a power of attorney (PoA) issued for that purpose shall be submitted.
When applying for withdrawal of a marketing authorisation or removal of information from the registers of medicinal products, marketing authorisation holders must report a medicine shortage to IMA in good time, or at least two months before stocks run out.
Marketing authorisation holders should inform doctors and pharmacies in good time
Marketing authorisation holders are strongly encouraged to inform doctors and pharmacies in good time about medicinal products that are to be withdrawn from the market, including information on when the medicinal product will no longer be available. This applies in particular to essential medicinal products, widely used medicinal products and medicinal products that are the only ones of their kind on the market, so that doctors have the opportunity to respond, for example by changing treatment.
Medicine shortages must be reported
Marketing authorisation holders must report to IMA any medicine shortage resulting from the withdrawal of a marketing authorisation/removal from the registers of medicinal products in good time, or at least two months before stocks run out. Medicine shortages can be reported on My pages.
It is preferable for marketing authorisation holders to apply for removal/withdrawal and report the medicine shortage at the same time, where a medicine shortage applies.
Why are marketing authorisations withdrawn or medicinal products taken off the market?
Medicinal products may only be placed on the market in Iceland once a marketing authorisation has been issued by the Icelandic Medicines Agency (IMA). It is the decision of the marketing authorisation holder whether a medicinal product that has been granted a marketing authorisation is subsequently placed on the market or not.
Withdrawal of a marketing authorisation and removal from the registers of medicinal products
Withdrawal of a marketing authorisation means that the marketing authorisation is cancelled, and it is therefore no longer permitted to place the medicinal product concerned on the market.
Removal from the registers of medicinal products, on the other hand, means that information on the medicinal product is removed from the registers of medicinal products (the medicinal product is no longer marketed), and the medicinal product is therefore no longer available even though its marketing authorisation remains valid.
Deregistration is a collective term for withdrawal of a marketing authorisation and removal from the registers of medicinal products. Withdrawal of a marketing authorisation and removal from the registers of medicinal products may also apply to individual pharmaceutical forms, strengths, package types and package sizes.
Reasons for withdrawal of a marketing authorisation
This often causes difficulties for doctors and patients, and IMA therefore strongly encourages that medicinal products remain on the market for as long as they are needed. If the reason for a request for withdrawal of a marketing authorisation is low sales of the medicinal product but there is considered to be a significant need for it, IMA seeks an appropriate solution, for example by reducing the fees for the medicinal product or by approaching other pharmaceutical manufacturers about placing a similar medicinal product on the market in Iceland.
Various other reasons may underlie the withdrawal of a medicinal product's marketing authorisation or the removal of information on a medicinal product from the registers of medicinal products. The medicinal product may not be available because its manufacture has been discontinued, because problems have arisen in the manufacture of medicinal products or their transport to Iceland, or because the assessment of the safety of using the medicinal product has changed.
The main reason for the withdrawal of a medicinal product's marketing authorisation or the removal of information on the medicinal product from the registers of medicinal products is low sales, and in such cases this is done on the initiative of the marketing authorisation holder.
Stocks of a medicinal product that no longer has a marketing authorisation
If the marketing authorisation of a medicinal product is withdrawn or information is removed from the registers of medicinal products for reasons other than safety, the general rule is that the medicinal product may be sold while stocks last, but for no more than three months from the date on which the marketing authorisation is withdrawn or the information is removed from the registers of medicinal products.
News published when considered necessary
In certain cases, IMA publishes a news item on its website stating that the marketing authorisation of a medicinal product is being withdrawn or that a medicinal product is being taken off the market. This applies in particular when considerable inconvenience can be expected once a medicinal product is no longer available, for example if a new medicinal product will need to be used in place of the one leaving the market, or if significant use is expected of a medicinal product that will only be available under a special exemption granted by IMA. An exemption is granted at the request of a doctor for each patient concerned and/or for use in a healthcare institution (exempt medicines). Exemptions are not expected to be granted for the prescribing of medicinal products that no longer have a valid marketing authorisation or are no longer marketed, if medicinal products marketed in Iceland can be used instead.