incident
- Guideline or reference source
- HMAGVP Guideline on good pharmacovigilance practices
- Definition
- A situation where an event occurs or new information arises, irrespective whether this is in the public domain or not, in relation to (an) authorised medicinal product(s) which could have a serious impact on public health. The incident may be related to quality, efficacy or safety concerns, but most likely to safety and/or quality (and possibly subsequent supply shortages). In addition, situations that do not seem at a first glance to have a serious impact on public health, but are in the public domain - subject of media attention or not- and may lead to serious public concerns about the product, may also need to be considered as incidents. Likewise, other situations which might have a negative impact on the appropriate use of a medicinal products (e.g. resulting in patients stop taking their medicine) may fall within the definition of an incident. In the context of this the European Union Regulatory Network Incident Management Plan for Medicines for Human Use Incident Management Plan, an incident relates to (a) medicinal product(s) authorised in the EU, irrespective of their route of authorisation
- Related Term
- crisis
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