Requested withdrawal of a marketing authorisation (MA) or deletion of information from drug catalogues
Keep the following in mind when requisting for withdrawal of a marketing authorisation (MA) or deletion of information from drug catalogues:
- Application for withdrawal of a marketing authorisation (MA) or deletion of information from drug catalogues must be sent to IMA in an application form to the email address [email protected]
- Entry into force drugs on the market is the first day of every month
- An application for withdrawal of a marketing authorization or deletion of information from drug catalogues must be received by the Icelandic Medicines Agency at least two months before the requested entry into force and will come into effect the first day of the requested month.
Withdrawal of MA means that the marketing authorisation is no longer valid and thereby it is prohibited to market the product.
Deletion of information from drug catalogues means that information about the drug is deleted from both the drug price list and drug information catalogue (SmPC, patient information and other information about the medicine), this means that the product can no longer bee prescribed, marketed or sold but the marketing authorisation is still valid and therefore the medicine can be relaunched on the market given that conditions for marketing ar met and publication in the drug catalogue is requested by the M.A. holder.
See further instructions here.
Reporting of Medicine shortages
Medicine shortages caused by deletion from drug catalogues/withdrawal of MA shall be notified to the Icelandic Medicines Agency in due time or no less than two months before stock out. Medicine shortages can be reported here. Ideally shortages and deletion from drug catalogues/ withdrawal of MA should be reported/requested simultaniously.
Withdrawal of MA and deletion of information from drug catalogues can be applicable to specific pharmaceutical forms, strengths, packages and pack sizes. When, the whole MA is not withrawn and texts are common to strenghts/pharmaceutical forms, this is done by applying for a change terms of the MA (type C.I.7) in addition to the submission of the application form for withdrawal of the M.A.