3. When are DHPCs disseminated?

A DHPC should be disseminated when there is a need to take immediate action, or change current practice, in relation to a medicinal product. The EMA guideline provides details about the different situations where a DHPC is necessary or should be considered. As specified in the EMA guideline, situations when a DHPC may become necessary are the following:

  • a suspension, withdrawal or revocation of an MA for safety reasons;
  • an important change to the use of a medicine due to the restriction of an indication, a new contraindication, or a change in the recommended dose due to safety reasons;
  • a restriction in availability or discontinuation of a medicine with potential detrimental effects on patient care.

Other situations where dissemination of a DHPC should be considered are:

  • new major warnings or precautions for use in the product information;
  • new data identifying a previously unknown risk or a change in the frequency or severity of a known adverse reaction;
  • new evidence that the medicinal product is not as effective as previously considered;
  • new recommendations for preventing or treating adverse reactions or to avoid misuse or medication error with the medicinal product;
  • ongoing assessment of an important potential risk, for which data available at a particular point in time are insufficient to take regulatory action.