• To submit a Risk Management Plan, according to the current guideline, including: o Detailed strategies for educating physicians including appropriate injection techniques, dosing and lack of interchangeability between products as well as programmes for continued and improved monitoring of spread reactions in clinical use and in clinical trials. o Information on usage patterns and on types of prescribers/ users of Xeomin in order to identify if and at what type of clinics off-label cosmetic use is taking place, especially in the EU. o Steps to be taken to ensure that patients are adequately informed of the safety issues associated with these products, e. g. adequate labelling and patient brochures.