MHRA considers removal or lessening of Risk Management Plan requirements for generics

The most interesting recommendation from the report on the Post-Implementation review (PIR) of the Human Medicines Regulations 2012 published by the Medicines and Healthcare products Regulatory Agency (MHRA) is as follows:

“MHRA to consider what more could be done to remove the potential barrier to market entry for generic Marketing Authorisation holders arising from the current requirement to create and maintain Risk Management Plans and prepare and distribute Risk Minimisation Measures. Timing: by March 2018.”

Companies face the additional burden imposed by the requirement for Risk Management Plans (RMPs) for all generics marketing authorisation (MA) applications, even when the requirement may be disproportionate to the risk. The UK negotiating position was that RMPs should not be required for all generic MAs, but should depend on the risk and the need for specific risk management.

Overall, the report concluded that there is widespread recognition from stakeholder engagement networks and the consultation that in general the 2012 Regulations represent a sound consolidation of fragmented and complex medicines legislation in one place, and in a simplified form to improve the continuity of the regulatory framework.

To view the final report for the Post-implementation Review of the Human Medicines Regulations 2012, please click here.