In accordance with the new Therapeutic Products Act, which entered into force on 1 January 2019, all serious adverse reactions that are hitherto unknown or insufficiently documented in the product information leaflet of the medicine concerned, as well as any other medically significant adverse reaction, must be reported.
Adverse reactions are considered serious if they:
- result in death
- are life-threatening
- lead to, or prolong, hospitalisation
- involve a persistent disability or incapacity
- are otherwise to be considered medically significant (if, for example, a timely medical intervention prevented one of the above-mentioned outcomes)
These suspected adverse reactions should be reported within 15 days of diagnosis; non-serious reactions should be reported within 60 days.
A causality between a reaction and a medicine need not be proved: suspicion alone is sufficient to justify reporting such events.
Although misuse, dependency and addiction are not covered by the WHO definition of an adverse drug reaction, as they do not relate to normal posology, it is important to report such events as they might affect the safety profile of a drug.