Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Referral procedures of Directive 2001/82/EC - General principles, analysis of Article 78 procedures and future outlook

Dr. Christina Wallkötter (Abschlußjahr: 2017)

Summary
Language: English
This thesis provides an introduction and overview on veterinary referral procedures in general with focus on Article 78 referral procedures of Directive 2001/82/EC.
Article 78 referral procedures - so-called ‘pharmacovigilance urgent measures’ - can be triggered by a Member State based on the evaluation of pharmacovigilance data. If such safety concerns arise, namely if a Member State considers withdrawal, suspension or variation (restriction of indications or availability, amendment of the posology, addition of a contraindication or new precautionary measures) of a marketing authorisation, this procedure applies.
Five Article 78 referral procedures of Directive 2001/82/EC have been started yet and all of them have already been finalised. The procedure length (from start to European Commission decision) varies between five and 31 months. Trigger for the procedures were in four cases adverse events in animals (anaphylactic type reactions, cases of Bovine Viral Diarrhoea, neurological signs, gastrointestinal disorders, cases of bovine neonatal pancytopenia) and in one case a human adverse event (after accidental self-injection).
Remarkably, all of the four Article 78 procedures that were based on adverse events in animals occurred in the species cattle.
Concerned product classes were endectocides, sedatives and in three cases vaccines. Two procedures resulted in negative risk-benefit-evaluations, while three procedures remained the products with a positive risk-benefit-balance.
Outcomes of the procedures were in three cases variation of the concerned marketing authorisation to mitigate risk and improve surveillance measures (amendment of the Summary of Product Characteristics and related product information, amendment of quality control) and in two cases suspension of the concerned marketing authorisations as the benefit-risk ratio was judged to have changed to being negative.
Pages: 42; Annexes: 0