In order to facilitate the planning of timetables of the Mutual Recognition Procedures (MRP) and the update of the Assessment Report, the MPA has introduced a routine for handling of first wave and repeat use MRP requests when acting as Reference Member State (RMS).
In accordance with the CMD(h) procedural advice on repeat use MRP, (see Procedural Advice On Repeat-Use CMDh/008/2009/Rev6) the MPA requires a variation application to update the dossier prior to the MRP or the Repeat Use procedure, unless the dossier is already fully compliant with current regulatory requirements. The update of Module 1 including all the below examples in preparation of a Repeat Use or MRP may be submitted as one single application according to type II. The change may be introduced under classification category C.I.z – Update of Module 1 in preparation of a MRP/RUP.
Such updates can concern submission of additional information in accordance with the requirements in the current legislation (Directive 2001/83/ EC as amended), i.e.:
- Results of consultations with target patient groups in accordance with article 59(3) of Directive 2001/83/EC or justification for not performing such consultation (Module 1.3.4).
- Proposed implementation of the Braille requirement on the packaging of the medicinal product concerned in accordance with article 56a of Directive 2001/83/EC. (Module 1.3.6).
- Environmental risk assessment in accordance with article 8 (ca) of Directive 2001/83/EC (Module 1.6) or justification for its absence.
- Information relating to the Pharmacovigilance including Pharmacovigilance system (Module 1.8.1) and Risk management system (Module 1.8.2) in accordance with article 8 (ia) of Directive 2001/83/EC.
- Qualified Persons (QPs) declaration in accordance with article 46(f) of Directive 2001/83/EC.
The variation application should be submitted before the request to start a MRP or a Repeat Use procedure has been filed. However, the variation procedure does not have to be completed prior to the submission of the MRP/Repeat Use request. The variation procedure and the update of the Assessment Report can be handled simultaneously.