• All suspected teratogenic effects
• All suspected reactions to new medicines (i.e. those authorised for less than five years)
• All suspected reactions to vaccines
• Serious* suspected reactions to established products
• Any suspected increase in the frequency of non-serious reactions

Further information on adverse reaction reporting can be found on the Reporting Suspected Product Problems page.

* Definition of Serious:
The term 'serious adverse reaction' means an adverse reaction which results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability, or incapacity, or in a congenital anomaly/birth defect.

Life threatening in this context refers to a reaction in which the patient is at risk of death at the time of the reaction; it does no refer to a reaction that hypothetically might have caused death if more severe.