Urgent Safety Restriction

An urgent safety restriction refers to a regulatory action taken promptly by the marketing authorization holder, a national regulatory authority, or the European Commission to address or prevent a risk to human or animal health or to the environment associated with a medicine or medical product.

In situations where new safety concerns or emerging evidence indicate a potential risk, the regulatory authorities may deem it necessary to implement immediate measures to ensure the safety of patients, animals, or the environment. This can involve imposing restrictions on the use, distribution, or marketing of the product.

The decision to initiate an urgent safety restriction is typically based on a thorough assessment of available data, including reports of adverse events, clinical trials, scientific studies, or any other relevant information. The regulatory authorities evaluate the potential risks and benefits associated with the product and determine the appropriate actions to mitigate or eliminate the identified risks.