RUP: repeat-use procedure

The repeat-use procedure has no separate legal text. It is the mutual recognition procedure of Article 28(2) of Directive 2001/83/EC used again after a first decentralised or mutual recognition procedure has closed, to extend the authorisation to Member States that were not in the original wave. The reference member state stays the same, updates its assessment report to reflect everything that has changed since the first procedure, and the new concerned member states recognise it. The CMDh publishes a best practice guide on repeat use that sets out the expectations.

Preparation matters more than the procedure itself. All pending variations must be finalised before the repeat-use procedure starts, so the dossier the new countries receive is the current approved one. The product information must already be harmonised across the existing Member States, and the dossier must be in eCTD with the full lifecycle visible to the reference member state. Each new concerned member state will also want its national requirements met: translations, mock-ups, local representative details and any national labelling text.

What goes wrong: starting a wave while a Type II variation is still open, which forces a wait or a withdrawal; a reference member state that has little capacity and offers a slot months away; national texts that differ from the common product information because earlier national variations were never aligned; and underestimating the national phase, when translations have to be approved and fees paid in each new country before marketing can begin. A new concerned member state can also raise questions on parts of the dossier that the original wave accepted years earlier, for example an outdated bioequivalence comparator or a manufacturing site whose GMP certificate has lapsed, and the applicant must answer within the standard timetable.

Companies sometimes change the reference member state before a repeat-use wave, for example when the original one has left the business or lost capacity. That is possible but needs the agreement of all authorities involved and adds time. Where many markets remain, a single large wave is usually cheaper than several small ones, because each wave carries its own reference member state fee and procedural overhead.