Amended policy for DHPCs and national implementation of additional risk minimisation measures

The Medicines Evaluation Board (MEB) has amended its policy for Direct Healthcare Professional Communications (DHPCs) and the national implementation of additional risk minimisation measures. This regards policy on medicinal products for human use.

The main changes are:

MEB 44 - Policy document for national implementation of DHPCs

  • A marketing authorisation holder can act on behalf of several marketing authorisation holders if there are multiple marketing authorisation holders.
  • Addition of substantiation for cooperation between marketing authorisation holders
  • The introduction of the White Hand Envelope (WHE)
  • The introduction of the Orange Hand or White Hand logo on the DHPC
  • Amendments in the template of the DHPC

MEB 45 - Policy document for national implementation of additional risk minimisation measures

  • The introduction of the White Hand Envelope (WHE)
  • Having additional risk minimisation material available online
  • Expansion of instructions for updates of existing additional risk minimisation material
  • Addition of instructions for stopping additional risk minimisation material
  • Addition of information on obligation for parallel distributor
  • Amendments in the template for material aimed at healthcare providers and the accompanying letter
  • Introduction of the template for material aimed at the patient / parents or caretakers of the patient

The amendments were made based on experiences with the assessment and implementation of the DHPCs and additional risk minimisation materials in practice.

The new policy is effective as from 11 June 2018 and does not apply to ongoing procedures. Previously approved additional risk minimisation material must comply with the new regulations from the moment a planned update of the material is submitted for assessment.

Policy formulation

For amendment of the policy, the MEB carried out a public consultation and submitted the proposal to healthcare providers (Medical Practice Committee) and representatives of the pharmaceutical industry.