Withdrawal, revocation, suspension or expiration of the marketing authorization of a drug refers to the process by which a drug loses its official marketing authorization in a particular country or region. This can happen for a variety of reasons, which may be related to the safety, efficacy and quality of the drug, or to a decision by the manufacturer.

• Safety concerns: Sometimes, serious adverse effects (German: Nebenwirkungen) or health risks that were not known at the time of the original assessment are identified after a drug has already been approved. New clinical studies or pharmacovigilance may reveal that the risks of a drug exceed its potential benefits.
• Insufficient efficacy: If further studies show that the drug has no therapeutic effect, the marketing authorization (German translation: Zulassung) must be revoked.
• Quality problems: Manufacturing defects, changes to the drug’s formulation without notifying the regulatory authorities or the use of raw materials of insufficient quality may lead to the withdrawal or revocation of a drug’s marketing authorization.
• Compliance with regulations: Changes in legislation may make it necessary that a drug be re-approved.
• Waiver by the manufacturer: Sometimes the manufacturer is the one who initiates the expiration of the marketing authorization of a drug, e.g. due to low demand or a strategic decision by the company to discontinue production.

The competent authority must withdraw the authorization if it determines that not all the necessary criteria were met when the authorization was granted. If at any point in time these criteria are no longer being met, this is referred to as a revocation (translation into German: Widerruf). In some cases, a temporary suspension of the marketing authorization can also be ordered in order to give the pharmaceutical manufacturer the opportunity to remedy any deficiencies. A marketing authorization may also expire if it is not used for a certain period of time, is not renewed, or if it is waived in writing.

The withdrawal of a marketing authorization is an important instrument for ensuring the safety and efficacy of drugs on the market. Market authorization withdrawal helps to protect patients from potentially harmful or ineffective drugs and maintain high standards in the healthcare system.

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