6. Direct healthcare professional communication. Communicating medicines safety information directly to healthcare professionals: an introduction to DHPC

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5. DHPC detailed processing

The roles and responsibilities of the NCAs, the EMA and the MAH differ, regarding the preparation and processing of DHPCs, according to the route of authorisation of the medicinal products. There are three possibilities:
  1. The medicinal product has been authorised at the EU level (centrally authorised product or ’CAP’) or the product is subject to an ‘EU referral procedure for safety reasons’: The EMA coordinates the review of the DHPC within its scientific committees/groups and with NCAs.
  2. The medicinal product has been authorised via the ‘mutual recognition’ or ‘decentralised’ procedures: The ‘reference member state’ coordinates the process with the MAH, while the ‘concerned member states’ are kept informed of any proposed actions.
  3. For strictly nationally authorised medicinal products (‘NAP’): The MAH should submit the draft DHPC and any communication plan to the competent authorities of the member states where the product(s) is/are authorised.

A flow chart describing the entire processing of DHPCs is provided in Figure 1.

Flow chart for the processing of Direct Healthcare Professional Communications (DHPCs) in the EU

Figure 1: Flow chart for the processing of Direct Healthcare Professional Communications (DHPCs) in the EU (taken from the EMA guidelines document Guideline on good pharmacovigilance practices (GVP) - Module XV – Safety communication (Rev 1) (europa.eu))

TT = Time Table, NAP = Nationally Authorised Product, MR = Mutual Recognition Procedure,
DP = Decentralised Procedure