Guidelines for letters requesting withdrawal of medicinal products.

Please consider the following when writing a letter requesting withdrawal of a medicinal product.

The annual dates for products marketed in Iceland are the following: 1 January, 1 April, 1 July and 1 October. Medicinal products that have never been placed on the market in Iceland can be withdrawn any month.

The request needs to be received by the Agency at least one and a half months before the next regular unlisting date, in order for it to be processed timely.

• The letterhead must contain information on what should be unlisted, e.g. proprietary medicine, pharmaceutical form or package.
• Only one marketing authorisation holder per letter.
• There should be separate letters for MR/DC and nationally authorised products.
• A Nordic product ID (Vnr) of the relevant proprietary medicine, pharmaceutical form or package must be clearly stated as well as the relevant marketing authorisation numbers.
• If the corresponding medicine has not been placed on the market, that must be stated also.
• The reason for the request must be given as well as statistic of sale for the previous year.

Guidelines for letters on deleting information from the official Medicinal products Price List

• The same information is requested as stated above for the withdrawal procedure.