When Is A Pharmacovigilance Agreement Required

This is a question that was recently asked in a blog of the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA). One might think that wholesalers in Europe do not regularly receive information on adverse events (which may be more common in other countries outside the EU). This type of information could be obtained primarily by parallel import stakeholders. However, a wholesaler may be able to receive safety information. And it seems that many are not aware of their responsibilities with this pharmacovigilance (PV) data. In this regard, a contract may be useful, particularly when a wholesaler offers pv services to the holder of the marketing authorization (MAH). I think the above situation is covered by the blog statement: “There may be situations where an agreement is not necessary, for example if the wholesaler is not in a contractual relationship with the MAH.” However, the blog suggests that, in such cases, the wholesaler must respect GDP and I am not so sure of the GDP requirements that apply in Africa… The processing of security data varies somewhat between the United States, the EU and other areas, but, in general, the obligation to expedite security reports on suspected serious adverse events to the relevant authorities is similar, at least from areas. The period during which reports are to be received begins when the report is received by the third-party/subcontracting provider, NOT when the report reaches the MAH. It is therefore in the interest of the MAH that the reports be forwarded to them (or to the service provider) in order to obtain them as quickly as possible, so that they can be processed properly and on time. The SDEAs vary depending on the role of the third part. If the third party only carries out sales activities, their exposure to security data may only require simple instructions on what to do if they run into problems.

If the third party is more involved, a distributor, co-marketing companies, co-developer companies or licensees, the SDEA will be more detailed. If outsourced activity is pharmacovigilance, ADEDs need to be more detailed, as it is essential that all parties involved are aware of their security reporting responsibilities and processes. These MA holders may have to establish different business relationships with other pharmaceutical companies or cros or other service providers in order to obtain the necessary authorization and market their manufacturing forms. These commercial relationships vary according to the requirements/consents/commitments/interests of both counterparties.

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