The crisis management system for veterinary medicinal products at the BVL is described in the “Crisis Management Plan Department 3”. This plan applies to all incidents up to a crisis in the area of veterinary medicinal products, regardless of the type of marketing authorisation. These incidents can affect the

• efficacy
• safety
• quality
• supply
• misuse

of one or more veterinary medicinal products and thus pose a risk to human health, animal health or the environment.

Examples for instance are:

• urgent safety risks, i.e. pharmacovigilance issues
• quality defects of veterinary medicinal products and their active substances, e.g. contamination, altered active substance content, non-GMP-compliant manufacturing
• counterfeit veterinary medicinal products
• political events
• production and supply chain disruptions or export bans that can lead to shortages
• events/information related to changes in the legal framework at national or EU  level (e.g. changes in the classification of certain substances or substance classes)

The crisis management system of Department 3 comprises all tasks in the general organisational structure for veterinary medicinal products (AAO TAM) and the special organisational structure for veterinary medicinal products (BAO TAM) for the prevention and management of incidents up to crisis. The established system of risk management and risk communication of Department 3 is the first stage of the crisis management system for the prevention of situations (AAO TAM). The BAO TAM system, consisting of crisis management and crisis communication, is the second level for dealing with special incidents up to crisis within the crisis management system.

The crisis management plan of Department 3 provides a framework for action that does justice to the uniqueness of situations such as a special incident, event or crisis and allows sufficient flexibility in the course of action. The crisis management plan provides a quick overview before and during the occurrence of a situation (“Lage”): It defines and describes the necessary process steps as well as the involvement of stakeholders and their responsibilities.

Factors that can initiate the crisis management plan include new findings from the above-mentioned areas, including the pharmacovigilance or rapid alert system, information from marketing authorisation holders or authorities, groups and committees as well as, for example, newly published data from scientific journals, reports in the media and/or measures taken by an EU or non-EU regulatory authority with regard to actual or alleged effects on human, animal health or the environment.

In addition, the crisis management plan of Department 3 can also be initiated if the Incident Management Plan (IMP) and/or the Incident Review Group (IRG) of the EMA are being activated on European level.

Before a situation occurs, risk management is active within the framework of the AAO TAM. Risk management is the first level of the crisis management system Department 3. Fulfilment of the regulatory tasks as part of risk management minimises the risk of an incident occurring. However, gradual, slow-building or sudden, unexpected and/or unforeseen events can lead to the suspicion that a situation (“Lage”) may have occurred and thus trigger the application of the crisis management plan.

The BVL crisis management for the area of food, feed and consumer products is described in the following section in German language.

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