Withdrawal of marketing authorisation for medicinal products

Reasons for withdrawal

The most common cause for a medicinal product being withdrawn is low sales.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 and the Swedish Medical Products Agency finds that it is important that the product remains on the market, the Agency informs the company of this.

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.

The Swedish Medical Products Agency recommends that medicinal products that are to be withdrawn should be phased out, so that the stock is depleted prior to the withdrawal date. After effective date of withdrawal, no packages left in stock can be sold on the Swedish market. An assessment should be made regarding the number of pharmaceutical packages in order to avoid a recall of remaining packages.

If product remains on the market after the withdrawal date, the marketing authorisation holder should contact the Swedish Medical Products Agency for a dialogue on how the remaining products should be handled.

Phone +(0)18 17 46 00. Tell the operator that you are calling regarding recalls and request to be connected to the Department of Drug Inspectorate – Industry and Hospital.

Application

• The application for withdrawal should be sent to the Swedish Medical Products Agency regarding products authorised within national procedure, decentralised procedure, and mutual recognition procedure. The application for withdrawal regarding medicinal products approved within the centralised procedure should be sent to EMA.
• An application for withdrawal may include several medicinal products from the same marketing authorisation holder. However, medicinal products for human use and medicinal products for animals should be submitted in separate applications.
• In case the withdrawal has effect on the product information, the SmPC, PL, and if necessary, the labelling text should be enclosed in word format with changes highlighted.
• If Sweden is the RMS for the medicinal product and an RMS switch needs to be carried out as a result of the withdrawal, complete the application with which country will be the new RMS and the new procedure number.
• If the application is submitted on behalf of the marketing authorisation holder or local representative, a power of attorney should be enclosed.

Send this form by email or mail.

Email: 
RIC@lakemedelsverket.se

Mail:
Läkemedelsverket
P O Box 26
751 03 Uppsala
Sweden

Handling 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 for the coming year, the application for withdrawal needs to be received by the Swedish Medical Products Agency no later than the last of October the year before, to be sure that the assessors will have enough time to finalise and set withdrawal date to 31 January the year the fee applies.The handling of an application can be faster, but the number of applications is at its highest at the end of the year.

Additional information

It is common for the marketing authorisation holder to inform the healthcare providers and pharmacies about the withdrawal, in some cases with references to other medicinal products that can replace the withdrawn product.

In special cases, the Swedish Medical products Agency publishes information before the withdrawal. This could be, for example, if patients who use the medicinal product needs to start treatment with another product, or if a high license prescription can be expected as a result of the withdrawal.
The information is published on the Swedish Medical Products Agency´s website and in some cases the information is sent directly to the hospitals, pharmaceutical committees and expert groups concerned.

Withdrawn medicinal products

Medicinal products that have been withdrawn from 2004 onwards can be searched on the Swedish Medical Products Agency´s website.
It is possible to search individual medicinal products, or medicinal products that meet specified keywords, for example all medicinal products that contain a certain substance. It is also possible to search for all medicinal products that have been withdrawn during a certain period of time.

The list can be exported to Excel or in XML format. The exported list includes information about ATC code, prescription status, withdrawal date, among other things.