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Pharmacovigilance – Pharmacovigilance Center Berlin

The term pharmacovigilance (from pharmakon: drug; vigilare: to be vigilant) refers to the systematic recording and evaluation of adverse drug reactions (ADRs) by authorities, marketing authorization holders and healthcare professionals.

The task of pharmacovigilance is to monitor the safety, quality and efficacy of medicinal products and to prevent problems during their use.

In order to strengthen pharmacovigilance (PhV), regional pharmacovigilance centers have been created at some veterinary universities, including the FU Berlin at the Institute of Pharmacology and Toxicology under the direction of Prof. Dr. Wolfgang Bäumer. This PhV center acts as a local contact point for questions and is intended to actively support Berlin university clinics of the School of Veterinary Medicine in reporting suspected cases of adverse drug reactions in veterinary medicine. This is a cooperation with the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL – Federal Office of Consumer Protection and Food Safety), which is responsible nationwide for monitoring the safety of veterinary medicinal products after authorization.

According to §8 (2) of the professional code of conduct of the Berlin Chamber of Veterinarians, adverse drug reactions or deficiencies that become known during the practice of veterinary medicine must be reported immediately to the competent authority or the Drug Commission of the Federal Chamber of Veterinarians.

What to do if adverse drug reactions are suspected?

In the case of clinical symptoms of unknown cause that occur in temporal connection with the administration of a medicinal product, an adverse drug reaction (ADR) should always be considered as a differential diagnosis.

Any suspected ADR should be reported to the competent authority in order to support efficient post-authorization drug safety monitoring.

What should be reported?

  • Adverse reactions
  • Interactions with other medicinal products
  • Insufficient withdrawal period
  • Lack of efficacy
  • Resistance in bacteria and parasites
  • Effects on persons who have had contact with the medicinal product and
  • Negative effects on the environment

ADRs already known and described in the instructions for use should also be reported! 

How should reports be submitted?

Your contact person for submitting reports is Mirjam Watta, PhD student at the Institute of Pharmacology and Toxicology at Freie Universität Berlin. From here, the reports are recorded and forwarded to the BVL. All reports are treated anonymously and processed exclusively for pharmacovigilance purposes. The report can be submitted using the form or via VETERA.

For further questions regarding pharmacovigilance, please contact:

Link to the concact form

BVL pharmacovigilance: https://www.bvl.bund.de/DE/Arbeitsbereiche/05_Tierarzneimittel/01_Aufgaben/04_UeberwachungRisikomanagement/01_Pharmakovigilanz/tam_Pharmakovigilanz_node.html

BVL adverse drug reactions: https://www.bvl.bund.de/DE/Arbeitsbereiche/05_Tierarzneimittel/02_Verbraucher/02_UAW/01_UAW/tam_uaw_node.html

Signal management: https://www.bvl.bund.de/DE/Arbeitsbereiche/05_Tierarzneimittel/01_Aufgaben/04_UeberwachungRisikomanagement/02_Signalmanagement/tam_Signalmanagement_node.html