• Predložitev načrta za obvladovanje tveganj v skladu z veljavno smernico, vključno s: podrobno strategijo za izobraževanje zdravnikov, ki vključuje ustrezno tehniko injiciranja, o odmerjanje in neobstoj medsebojne zamenljivosti med izdelki, kakor tudi programe za kontinuiran in izboljšan nadzor širjenja pri klinični uporabi in kliničnih preizkušanjih; informacijami o vzorcih uporabe in tipih predpisovalcev/ uporabnikov zdravila Xeomin, da o bi tako identificirali ali in v kakšnem tipu klinik prihaja do " off- label " uporabe (za namene, ki niso navedeni v registraciji zdravila) za kozmetične namene, zlasti v EU; potrebnimi koraki, da bi zagotovili, da so bolniki ustrezno informirani o vidikih varnosti o pri teh izdelkih, npr. ustrezno označevanje in brošure za bolnike; te informacije morajo vključevati izrecen napotek, naj bolniki takoj poiščejo zdravniško pomoč v primeru nastopa težav s požiranjem, govorom ali dihanjem; dogodke, povezane s širjenjem toksina, je treba izrecno vključiti v seznam dogodkov za o aktivno spremljanje; ovrednotenjem reakcij, povezanih s širjenjem, specifično kot del prihodnjih študij; o zavezo k opozorilu pristojnih nacionalnih organov v primeru pomembne spremembe v o pogostosti poročil.
• 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. Specifically this information should include advice to seek immediate medical help in the event of swallowing, speech or respiratory difficulties arise. o Specifically include toxin spread events in their sentinel list of events for active monitoring. o Evaluation of the spread reactions, specifically as part of future studies. o Commitment to alert the National Competent Authorities if there is a significant change in reporting rate.