MHRA shares views on responsibilities of MAHs participating in work-sharing initiatives for additional risk minimisation measures

In their latest Inspectorate blog, the MHRA outlines the expectations of the their Good Pharmacovigilance Practice (GPvP) Inspectorate with regards to the responsibilities of marketing authorisation holders (MAHs) participating in work-sharing initiatives for additional risk minimisation measures (aRMMs).

Most medicine safety concerns are adequately addressed by routine risk minimisation measures. These often involve using the summary of product characteristics (SmPC), the package leaflet and the prescription status of the product. Sometimes, for certain important risks, routine risk minimisation may be insufficient and aRMMs may be required. There is no prescription for such additional measures which vary from product to product and risk to risk but could include direct to healthcare professional letters, educational programmes, controlled access programmes and pregnancy prevention programmes.

Risk management is an evolving field and there is recent precedent for MAHs working collaboratively to develop and communicate harmonised educational materials to healthcare professionals and patients, e.g., when the MAHs hold licences for the same active substance or combination of active substances. This kind of collaborative approach is known as a ‘work-sharing initiative’.

There is no ‘one size fits all’ in terms of the design of a work-sharing initiative but often one ‘person’ (company, legal entity or trade body) may take a leading role to coordinate all aRMMs on behalf of all MAHs within the consortium. The MHRA blog article stresses that “Irrespective of the design of the work-sharing initiative, each individual MAH retains legal responsibility to operate a risk management system for its authorised medicinal products (Directive 2001/83/EC as amended, Article 104(3)(c)).”

It is therefore essential that for each work-sharing initiative, signed contract(s) that detail the arrangements for delegation and the responsibilities of each party are in place. If information and records associated with the aRMMs are held solely by a third-party, the contract should ensure the timely provision of such information and records to individual MAHs on demand for the purposes of audit and inspection.

The MHRA advice states that when pharmacovigilance tasks are delegated to a third-party, the agency would expect to see a mechanism of oversight by the individual MAHs. There are a number of ways that this oversight could be achieved and it should also be written into the relevant contract(s), for example, by:

  • Periodic reporting on the fulfilment of activities by the third-party, along with associated evidence demonstrating that aRMMs have been communicated in accordance with the approved plan.
  • Written confirmation that the third-party to whom activities have been delegated has a quality system that would ensure that process deviations are recorded, assessed and remediated, and notified to the relevant MAH. The third-party might also commit to conducting its own audits of the delegated activities, the results of which could be shared with concerned parties. This is reasonable as long as the MAH is content with the qualifications and procedures associated with these third-party audit activities.
  • Independent audit conducted by, or commissioned by, the MAHs within the consortium (potentially in collaboration), if the activity is considered sufficiently high risk. It is expected that all MAHs operate a risk-based pharmacovigilance audit programme and that third-parties involved in the delegation of risk management activities undergo a suitable risk assessment.


Whatever means are used, oversight activities should be documented.

Regulis has previously acted on behalf of a group of MAHs for products with the same active ingredient, working on with the MHRA to an important identified risk. With this previous experience, we strongly advocate following the MHRA’s advice, not only to ensure the agency’s expectations are met when a company is GPvP inspected but also to ensure the safety of patients.

To read the full blog article, please click here.