Translation, dissemination and publication of DHPCs

For centrally authorised products, products subject to an EU referral procedure for safety reasons and, in most cases, for 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 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 products and products subject to an EU referral procedure for safety reasons, 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.

The competent authorities may publish the final DHPC. The timing for such publication should be aligned to that of the dissemination of DHPC in the Member States.

The competent authorities may also issue an additional safety announcement, and disseminate the DHPC to relevant healthcare professionals’ organisations as appropriate.

Route of Authorisation and Roles and Responsibilities

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 (see Table 5).

Table 5

Coordination of Safety Announcements

The Agency should decide for each case, on the basis of the public health relevance and urgency of the safety concern, the population and number of Members States affected and the potential for media attention, whether further action in addition to the dissemination of the safety announcement is needed.

Coordination of safety announcements should be done in cooperation with the concerned marketing authorisation holder(s).

The exchange and coordination of safety announcements within the EU regulatory network should make use of the EU Early Notification System (ENS).

Competent authorities should bring to the attention of the EU regulatory network any such safety information that they become aware of, together with the timing of the publication if known (e.g. scientific journals, learned societies).

As soon as a marketing authorisation holder in the EU intends to make a public announcement relating to information on pharmacovigilance concerns in relation to the use of a medicinal product, and in any event at the same time or before the public announcement is made, the marketing authorisation holder shall be required to inform the competent authorities in Member States, the Agency and the European Commission [DIR Art 106a].

Whenever a marketing authorisation holder becomes aware that a third party (see below highlighted in red) intends to issue communication that could potentially impact the benefit-risk balance of a medicinal product authorised in the EU, the marketing authorisation holder should inform the relevant competent authorities in Member States and the Agency and make every effort to share the content of the communications with the relevant authorities.

Third parties (e.g. scientific journals, learned societies, patients’ organisations) are encouraged to inform the Agency and the competent authorities in Member States of any relevant emerging information on the safety of medicines authorised in the EU and,…

For the purpose of coordination, the Agency shall use English to inform the EU regulatory network of any safety announcement.

For the purpose of coordination, the Agency shall use English to inform the EU regulatory network of any safety announcement.

Safety Announcements

The intention of this on-line learning module is to highlight for you the key elements of the operation of the EU regulatory network taking into account the fact that patients and healthcare professionals in the EU look at competent authorities as providers of important information on medicines.

When issuing safety announcements, competent authorities may make use of the different tools and channels described in the section on “Means of Communication”.

Prior to the publication of a safety announcement, the Member States, the Agency or the European Commission shall inform each other not less than 24 hours in advance unless urgent public announcements are required for the protection of public health [DIR Art 106a(2)].

Only safety announcements listed in Table 4 and that pertain to active substances contained in medicinal products authorised in more than one Member of State require coordination within the EU regulatory network.

Table 4

The process

The operation of safety communication in the EU regulatory network is a complex process which in order to be effective needs coordination and cooperation within the EU regulatory network. This process can be divided into two major sub-processes as illustrated in Table 3:

Quality system requirements for safety communication

In accordance with the quality system requirements in Module I – Pharmacovigilance systems and their quality systems, procedures should be in place to ensure that safety communications comply with the principles described previously in “Principles of Safety Communication”.

In particular, the communications should be subject to quality controls to ensure their accuracy and clarity.

For this purpose review procedures with allocated responsibilities should be followed and documented

Measuring effectiveness of safety communication

Adequate mechanisms should be introduced in order to measure the effectiveness of the communication based on clear objectives. Measuring effectiveness allows lessons to be learned and helps in making decisions on prioritising and adapting tools and practices to meet the needs of the target audiences.

A research-based approach will normally be appropriate in order to establish that safety communications have met the standard described earlier in this course under “Principles of Safety Communication”. This approach may measure different outcomes including behaviour, attitudes and knowledge.

When evaluating the effectiveness of safety communication, the scope of the evaluation may be broadened to include factors other than the performance of the individual tools used in the safety communication (see Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators).

In the case of DHPCs, the marketing authorisation holder should be responsible for evaluating the dissemination of the DHPCs they prepare and should inform the competent authorities of the outcome and of any difficulties identified (e.g. problems related to the list of recipients or the timing and mechanism of dissemination)

Appropriate action should be taken as needed to correct the situation or prevent similar problems in the future

Effectiveness of safety communication

Safety communication is considered effective when:

The message transmitted is received and understood by the target audience in the way it was intended, and appropriate action is taken by the target audience.

Other means of communication

In addition to those described previously, there are other tools and channels such as publications in scientific journals and journals of professional bodies.

Some tools and channels may be used in the context of risk management. Risk minimisation measures often include specific programmes for risk communication.

Tools used in such programmes, such as patient alert cards or educational materials, are outside the scope of this module and are described in more detail in Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators.

Responding to enquiries from the public

Competent authorities and marketing authorisation holders should have systems in place for responding to enquiries about medicines from individual members of the public.

Responses should take into account the information which is in the public domain and should include the relevant recommendations to patients and healthcare professionals issued by competent authorities.

Where questions relate to individual treatment advice, the patient should be advised to contact a healthcare professional.