Withdrawal of marketing authorization for medicinal products

The most common cause for a medicinal product being withdrawn is low sales. The withdrawal is then done on the initiative of a company. Other, less common, reasons for withdrawal of medicinal products may be production problems or the discovery of serious side effects of the medicinal product.

When a company wants to withdraw a medicinal product on its own initiative and the Swedish Medical Products Agency (Läkemedelsverket) finds that it is important that the product remains on the market, the Agency informs the company of this. When there are specific reasons, the Medical Products Agency can reduce fees in whole or in part. An exemption from the annual fee can therefore be possible in some cases when the reason for withdrawal is low sales. However, the Swedish Medical Products Agency cannot force a company to keep a product on the market.

Handling of application and annual fee

The handling of an application for withdrawal of marketing authorisation may take up to three months.

As a main rule, the application fee will not be reduced or refunded when the license of marketing authorisation is withdrawn. In order not to be issued an annual fee in the coming year, the application for withdrawal need to be received by the Medical Products Agency no later than the last of October the year before, to be sure that the assessors will have time enough to finalize and put withdrawal date to 31 of January the year the fee applies. .

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information