Direct healthcare professional communications
A marketing authorisation holder may send a direct healthcare professional communication (DHPC) to healthcare professionals to inform them of important new safety information about a medicine and any actions they should take. The European Medicines Agency (EMA) publishes DHPCs agreed at European Union (EU) level and links to national registers of DHPCs, as of February 2020.
DHPCs serve to inform healthcare professionals of, for example:
- a suspension, withdrawal or revocation of a marketing authorisation for safety reasons;
- an important change, for example a restriction of indication, a new contraindication or a change in the recommended dose;
- a medicine supply shortage;
- quality problems with a medicine.
DHPCs agreed at EU level include a communication plan specifying the intended recipients and the dissemination date.
National competent authorities may adapt the text agreed at EU level to their specific situation, so the final letter a healthcare professional receives may differ slightly from the version published on the EMA website.
For more information, regulatory guidance and templates, see:
For a list of DHPCs agreed at EU level and published by EMA, see:
- Ecalta 100mg powder for concentrate for solution for infusion (anidulafungin) - Solution for infusion must no longer be frozen
- Mepact 4mg (mifamurtide): Potential for filter leakage or malfunction
- Picato (ingenol mebutate) – Suspension of the marketing authorisation due to risk of skin malignancy
- Risks associated with systemic exposure to estradiol creams
- Ulipristal acetate 5 mg for uterine fibroids not to be used during ongoing review of liver injury risk
Please note that the information in these national registers may not be available in English.