Post-authorisation pharmacovigilance covers the activities carried out after a medicinal product has received its marketing authorisation. It includes the continuous monitoring of the product’s benefit–risk balance, as well as the implementation and follow-up of agreed risk minimisation measures.
When routine measures are not sufficient, additional risk minimisation measures (aRMMs) may be required as part of the risk management plan (RMP) to address specific safety concerns. These measures are designed to ensure that the conditions for safe and effective use of a product are understood and applied in clinical practice.
In this article, we look at how aRMMs are implemented in post-authorisation pharmacovigilance, and what is required to make them work in practice across multiple Marketing Authorisation Holders (MAHs). See also our previous blog on MAH’s post-authorisation pharmacovigilance responsibilities.
What are the MAH’s responsibilities in aRMM implementation?
For Marketing Authorisation Holders, aRMMs are not only defined in regulatory documentation – they must be implemented, maintained and followed up in practice throughout the product lifecycle. This includes ensuring that:
- agreed materials are developed and approved in line with regulatory requirements
- distribution reaches the intended target groups, such as healthcare professionals or patients
- implementation is consistent across all relevant markets
- activities are systematically tracked and appropriately documented
- effectiveness can be evaluated when required by authorities
In multi-MAH settings, such as products with both originator and generic versions, these responsibilities extend beyond a single organisation. Alignment is required between several MAHs, each with their own processes and priorities, which increases the need for structured coordination.
Where do common aRMM materials become challenging?
In practice, the main challenge is not defining the measures, but coordinating their implementation. Common aRMM materials require alignment across multiple areas:
- cost sharing between MAHs (e.g. the costs of designing and printing aRMM materials are divided based on sales figures)
- content, format and design of materials (harmonised between MAHs and approved by the national competent authority (NCA))
- printing and logistics (e.g. where printed materials will be stored and who is responsible for distribution)
- distribution, storage and tracking (e.g. maintaining a tracking log to provide a clear overview of material quantities)
- communication and coordination between stakeholders
Differences in expectations, timelines or internal processes can easily lead to delays or inconsistencies. Without a clear structure and defined ownership, implementation may become fragmented, even when regulatory requirements are well understood.
Case example: coordination of valproic acid aRMM materials
At a recent Information Day organised by the Estonian State Agency of Medicines, the implementation of common aRMM materials was discussed as part of a pharmacovigilance panel. The Agency highlighted the valproic acid aRMM project as a case where coordination between originator and generic MAHs worked particularly well.
The approach included:
- proportionate cost sharing between MAHs
- centrally managed design and printing
- central storage, distribution and tracking of materials
- regular, transparent reporting to all MAHs
Medfiles acted as an operational partner, coordinating the implementation across stakeholders and ensuring that agreed processes were followed in practice.
What supported a workable implementation model?
The example highlights a set of practical factors that are often decisive in multi-MAH environments:
- Central coordination: A single operational structure reduces complexity, streamlines communication and supports consistency across activities.
- Defined responsibilities: Clear roles and responsibilities minimise ambiguity and support timely execution.
- Transparency across MAHs: Regular reporting provides visibility into implementation and supports trust between stakeholders.
- Focus on implementation: Regulatory requirements were translated into processes that function in day-to-day operations, not only on paper.
From post-authorisation requirement to practical execution
aRMMs are defined as part of the post-authorisation risk management framework – but their effectiveness depends on how they are implemented in practice. As the valproic acid example demonstrates, successful implementation requires more than regulatory alignment. It depends on coordination, transparency and a structure that works across all involved MAHs.
At Medfiles, we support MAHs in implementing risk minimisation measures in practice, ensuring that post-authorisation requirements are translated into consistent, compliant and workable processes.
See also:
- How do post-marketing drug safety practices differ between Japan, the US, and the EU
- MAH’s post-authorisation pharmacovigilance responsibilities
- Safety database is a fundamental element of case processing
- Outsourcing ICSR processing – benefits and considerations
- Global pharma company & Medfiles: Obtaining and maintaining marketing authorisations
