In HaRP, active harmonisation will be pursued in RMPs in the following two domains:
• Domain 1 – RMPs for which data exclusivity of the reference product will expire. In this domain, the RMP of the reference product will be assessed in the context of revision 2 of GVP Module V and post-marketing experience with the product to date. Once an updated RMP is adopted, the List of safety concerns in this revised reference RMP will serve as the reference list to be used for the preparation of RMPs by other MAHs after expiration of data exclusivity.
• Domain 2 – List of safety concerns (from approved RMPs of active substances) as outlined on the current Excel list published on the CMDh website (data exclusivity already expired). In this domain, published Lists of safety concerns will be reviewed for those active substances for which there is no innovator product, or the innovator has no RMP. Following this initial review, in a subsequent consultation round feedback is asked from Pharmaceutical Industry and all Member States. During this round, also other relevant RMPs not included on the Excel list may be identified from other sources which may provide additional safety concerns that should be taken into account. It should be noted that the Excel list does not include all approved RMPs. These Lists of safety concerns will be aligned leading to a single harmonized List of safety concerns. Once adopted, this single
harmonised List of safety concerns version will serve as the reference list to be used for
preparation of RMPs by other MAHs and National Competent Authorities (NCAs) when assessing RMPs.
In both domains, the proposed harmonisation is in accordance with the GVP Module V rev. 2.
Algorithm harmonisation RMP domain 2
In domain 2, an additional algorithm has been agreed to harmonise the list of safety concerns. For active substances for which there is no innovator or the innovator has no RMP, only those safety concerns should be listed that either:
1. have ongoing additional pharmacovigilance activity, or
2. have ongoing additional risk minimisation measure, or
3. have essential targeted questionnaires in place.
All other safety concerns can be removed, unless there is a strong and compelling scientific argument as to why it should remain.
The table below is an example of the use of the algorithm for a safety concern in an RMP in domain 2. In this case, for the Important Identified risk of Myocardial infarction/infarction, neither additional pharmacovigilance activities, nor risk minimisation measures nor targeted questionnaires are in place, and this risk can therefore be removed from the list of safety concerns…