Outside of EMA business hours (we.elizabeth. Monday so you can Monday ahead of or once , from the vacations or for the Agencies getaways) you may also name the item crisis hotline: +29 (0)88 781 7600.
This is exactly an emergency matter and really should be studied simply inside the case regarding a probably serious problem which have a good centrally authorised equipment.
Sales and/or design authorisation proprietors try required to help you are accountable to EMA any equipment quality problem, as well as good guessed problem, away from an effective centrally authorised medication which will produce a remember otherwise unpredictable restrict toward also provide, pursuing the rules to the alerting high quality faults:
- complete the Faulty product declaration templateNote: This type must be exposed with an effective PDF reader.続きを読む →