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.