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Submitting RMP in the EU/EEA

A new RMP or an update of the RMP, as applicable, may need to be submitted at any time during a product's lifecycle.

Since July 2012, all new marketing authorisations (MAs) applications should include an RMP. However, as the provision of an RMP was not mandatory before that date, there are still MAs for some centrally authorised products without an RMP. It should be noted, however, that for these products without RMP there are situations (e.g. new safety concerns, significant changes to the MA) that may trigger the need to introduce an RMP. For medicinal products with an RMP, whenever new data are provided as part of a regulatory application in the post-authorisation setting, the MAH should consider whether consequential significant changes to the RMP are needed. Should this be the case, a revised RMP should be included as part of the regulatory application as it is the responsibility of the MAH to update the RMP whenever new information is being received that have a significant impact on the content of the RMP.

An RMP update is expected to be submitted at any time when there is a change in the list of the safety concerns or when there is a new or a significant change in the existing additional pharmacovigilance or additional risk minimisation activities. For example, a change in study objectives, population, due date of final results, a due date for protocol submission for an imposed study, or addition of a new safety concern in the key messages of the educational materials would be expected to be reflected in an updated RMP with the procedure triggering those changes. The significant changes of the existing additional pharmacovigilance and risk minimisation activities may include removing such activities from the RMP.

UPDATED RMP

An update of the RMP might also be considered when data submitted in the procedure results or is expected to result in changes of routine pharmacovigilance activities beyond adverse reaction reporting and signal detection activities, or of routine risk minimisation activities recommending specific clinical measures to address the risk. For example, an RMP update might be warranted with a significant change of the plans for annual enhanced safety surveillance (routine pharmacovigilance activity), or when monitoring of renal function is added as a recommendation in the Special warnings and precautions for use section 4.4 of the SmPC (routine risk minimisation activity). The need to update the plans to evaluate the effectiveness of risk minimisation activities should also be considered with such updates.

When an emerging safety issue is still under assessment (as defined in GVP Module VI), in particular in the context of a signal or potential risk that could be an important identified risk, an RMP update may be required if the emerging safety issue is confirmed and the important identified or potential risk requires to be added to the list of safety concerns in the RMP.

The need for an update to the RMP or a new RMP, including procedural aspects, should be discussed with the Agency, as appropriate, well in advance of the submission of an application, and in particular when involving a significant change to existing marketing authorisation and/or parallel procedures warranting an RMP update.

 

 

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RISK MINIMIZATION MEASURES

Risk minimisation measures are interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. Planning and implementing risk minimisation measures and assessing their effectiveness are key elements of risk management.

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Listing Safety Concerns when originator product has an RMP

When the MAH / Applicant for a generic medicinal product submits an RMP for assessment, the safety concerns should be aligned to those of the originator product that are available either from the originator’s approved RMP or from the list of safety concerns of the substance published on the CMDh website. Any divergence introduced in the RMP of the generic product (e.g. new safety concerns) should be thoroughly justified based on either difference in products’ characteristics (e.g. excipients), or on compelling data generated with this generic product that would warrant a difference in the list of safety concerns in the RMP (e.g. clinical trial or post-marketing epidemiological study data). This justification should be detailed in Module SVII of Part II of the RMP.

EU/EEA - How can a MAH achieve identical RMPs in different procedures?

If the MAH has applied for products in the same substance class via different procedures, the need for separate RMPs should be discussed with the RMS/NCA and they may request an RMP that only includes the product in question for their procedure.

For different already authorised products: MAH needs to submit a work-sharing variation to update the RMP if it wants to have one identical RMP covering multiple different authorisations.

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