Are pharmacovigilance agreements necessary for wholesale distributors?

In a recent blog article, the MHRA Inspectorate discussed the need for pharmacovigilance agreements between wholesale distributors (WD) and marketing authorisation holders (MAHs). The general consensus of the blog is that it depends on the likelihood of that WD receiving any safety related information. If there is a chance that they will receive any safety related information, or if they provide a service that relates to pharmacovigilance, then the WD are considered an extension of the MAH’s pharmacovigilance team. In this case it is necessary to have an agreement between to two companies to ensure that activities performed are done in accordance to the legislation and that no important safety information is lost.

There various factors that influence whether an agreement is necessary such as whether the WD appears on the product packaging or if the MAH does not have a local presence in the market where the product is being distributed. These need to be considered along with many other factors need to be considered. Furthermore, relevant guidelines state that it is up to the MAH to ensure that procedures are in place to ensure that collection and reporting of adverse events are correctly executed. It also states that these procedures and agreements must clearly define the responsibilities and timelines for the exchange process of safety data.

When am MAH is deciding on the details of a contract with a WD, the MAH must take into account all factors and deliberate on whether there is a potential for the WD to become a source of safety information.

To read the MHRA Inspectorate blog for a more in depth discussion, click here.