XV.C.2. Direct healthcare professional communications (DHPCs) in the EU

In the EU, a direct healthcare professional communication (DHPC) (see XV.B.5.1.) is usually disseminated by one or a group of marketing authorisation holders for the respective medicinal product(s) or active substance(s), either at the request of a national competent authority or the Agency, or on the marketing authorisation holder’s own initiative. The marketing authorisation holder should seek the agreement of the relevant national competent authorities or the Agency regarding the content of a DHPC (and communication plan) (see GVP Annex II) prior to dissemination.

XV.C.2.1. Processing of DHPCs

The situations when a DHPC is necessary or should be considered are provided in XV.B.5.1.. When drafting a DHPC, the template (see GVP Annex II) and the guidance provided in the annotations in the template should be followed as appropriate.

The roles and responsibilities of the competent authorities in a Member State, the Agency and marketing authorisation holders in the preparation and processing of DHPCs depend on the route of authorisation of the medicinal products concerned:

• for centrally authorised medicinal products and for medicinal products subject to an EU procedure, the relevant marketing authorisation holders should submit the draft DHPC and communication plan (including the intended recipients and the timetable for disseminating the DHPC) (see GVP Annex II) to the Agency, which should coordinate the review process by its scientific committees (i.e. PRAC and CHMP) and CMDh.
• for medicinal products authorised through the mutual recognition or decentralised procedure, the marketing authorisation holder should submit the draft DHPC and communication plan to the Reference Member State, which should co-ordinate the process with the marketing authorisation holder, while keeping the concerned Member States involved in the process.
• for purely nationally authorised medicinal products, the marketing authorisation holder should submit the draft DHPC and any communication plan to the competent authorities of the Member States where the medicinal products are authorised.

The marketing authorisation holder should allow a minimum of two working days for comments during the review. However, whenever possible, more time should be allowed. The timing may be adapted according to the urgency of the situation.

The Agency will coordinate the review of DHPCs within its scientific committees/groups as appropriate (i.e. involvement of PRAC, and finalisation by CHMP or CMDh as relevant). The PRAC should always be involved in the review of DHPCs related to a safety concern being discussed at the PRAC and the DHPC should form part of the PRAC assessment. The Agency may also request advice from PRAC on issues related to other safety communications.

There might be situations where a single DHPC prepared at EU level may not be suitable as there may be differences in Member States (such as differences in available therapeutic alternatives) which cannot be addressed in a single DHPC. In such cases, it is proposed that a core EU DHPC is agreed at EU level setting out core EU messages. The core EU DHPC can then be complemented at national level with additional information to address the different national situations (i.e. in relation to availability and choice of alternative treatments).

Although there will be national tailoring of such DHPCs, any core messages agreed at EU level should be preserved (i.e. tailoring should not conflict with these core messages).

In each Member State, when several marketing authorisation holders are concerned (i.e. when the DHPC covers several products with the same active substance or products of the same therapeutic class), marketing authorisation holders are strongly encouraged to arrange for one marketing authorisation holder to act on behalf of all concerned marketing authorisation holders as the contact point for the national competent authority. Where generics are involved, the contact point should normally be the marketing authorisation holder of the originator product. If no originator product is marketed in a Member State, one of the concerned generic companies is encouraged to act as the contact point. Such coordination between concerned marketing authorisation holders aims to ensure that healthcare professionals in a given Member State receive a single DHPC covering all the medicinal products affected by a single safety concern (same active substance or a class review). The marketing authorisation holder acting as contact point for the national competent authority and on behalf of all other marketing authorisation holders should be specified in the agreed communication plan (see GVP Annex II) to facilitate coordination.

Once the content of a DHPC and communication plan from the marketing authorisation holder are agreed by national competent authorities or the Agency, the national competent authorities or the Agency should share the final DHPC and communication plan using the early notification system (see XV.C.1.1.), and the Agency or the national competent authority as relevant should coordinate any subsequent safety announcement as appropriate using the process described in XV.C.1.1.. The early notification system is only used if the DHPC concerns an active substance authorised in more than one Member State.

In cases where an authority outside the EU requests the dissemination of a DHPC in their territory for a medicinal product also authorised in the EU, the marketing authorisation holder should notify the relevant competent authorities in the EU. This is part of the legal requirement under which the marketing authorisation holder shall notify the competent authorities of any new information which may impact the risk-benefit balance of a medicinal product [REG Art 16(2) and DIR 23(2)]. The need for any subsequent communication, e.g. a DHPC, in the EU should be considered and agreed on a case-by-case basis.

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

XV.C.2.2. Translation and dissemination of DHPCs

For centrally authorised medicinal products, medicinal products subject to an EU procedure and, in most cases, for medicinal products authorised through the mutual recognition or decentralised procedure, the working language for preparing the DHPCs will normally be English.

Once the text of the DHPC is agreed, the marketing authorisation holder should prepare translations in the official languages of the Member States, as specified by the Member States where the DHPC is to be distributed. The draft translations should be submitted to the Member States for a language review and such review should be done within a reasonable timeframe which should not exceed 4-5 working days. Member States should aim at reviewing the translations ideally within 48 hours.

For centrally authorised medicinal products and medicinal products subject to an EU procedure, the relevant marketing authorisation holder should provide the Agency with a complete set of all final EU official language versions as well as any additional related communication documents.

XV.C.2.3. Publication of DHPCs

The competent authorities may publish the final DHPC. The marketing authorisation holder will be informed of the intent to publish the DHPC so that the timing for such publication is aligned to that of the dissemination of DHPC in the Member States. The competent authorities in the Member States may also issue an additional safety announcement (see XV.B.5.2.), and disseminate them to relevant healthcare professionals’ organisations as appropriate.