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Does MAH need to execute Safety Agreement with a Wholesaler?

Factors influencing whether an agreement is required

The MAH needs to assess if the wholesale distributor they have engaged with is a potential source of safety information (such as reports of adverse reactions, medical enquiries or product quality complaints), and/or are providing pharmacovigilance services on behalf of the MAH, and whether an agreement is required to fulfil pharmacovigilance requirements. Some factors which are likely to result in an agreement being required include:

  • if the name and/or contact details of the wholesale distributor appears on product packaging, the patient information leaflet (PIL) or the MAH’s website,

  • if the MAH does not have a contactable presence in the market where the product is being distributed, which may increase the likelihood of the wholesale distributor becoming a point of contact by a member of the public or health care professionals (HCPs),

  • if the wholesale distributor is providing services which may increase their interaction with HCPs and the likelihood of receiving safety information, such as actively promoting products via a sales team,

  • if the wholesale distributor is performing pharmacovigilance services on behalf of the MAH, for example, undertaking follow-up of adverse events in their territory on behalf of the MAH, undertaking local literature searching activities or distributing risk minimisation materials.

The above list is not intended to be exhaustive and the MAH should consider all factors which may result in the wholesale distributor becoming part of the MAH’s pharmacovigilance system.

There may be situations when an agreement is not required, for example, if the wholesale distributor is not in a contractual relationship with the MAH and would not be regarded as a potential source of safety information and thus would not form part of the MAH’s pharmacovigilance system.