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Pharmacovigilance Technical Agreement

By Zach Arnold | April 11, 2021

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Outsourcing pharmacovigilance and allocating drug safety and regulatory activities can significantly reduce costs and workload for each marketing authorization holder (MAH). However, overall responsibility and monitoring of the pharmacovigilance system remains the responsibility of the MAH and the EU QPPV. In particular, it is the MAH`s responsibility to properly receive the process and expedite reports on adverse events and other safety reports if necessary. Although all pharmacovigilance activities are outsourced, overall responsibility lies with the MAH. The legal and regulatory responsibility for any failure of a pharmacovigilance provider to properly comply with pharmacovigilance legislation rests with the MAH, not with the company to which pharmacovigilance has been outsourced. 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… Very interesting information. I have already had discussions with PV Legal groups who have stated that when the wholesaler buys the product from MAH, there is no longer a relationship between the parties and that the wholesaler now owns the product and therefore there is no obligation to have a safety agreement or clause in the main agreement to send the AEs declaration to the MAH. It would appear that the point in this article (see below) may cover this: “There may be situations where an agreement is not necessary. B, for example, if the wholesaler is not in a contractual relationship with the MAH and is not considered a potential source of safety information and therefore would not be part of the MAH`s pharmacovigilance system.” Does the author clarify this for me? There may be situations in which an agreement is not necessary. B, for example, if the wholesaler does not have a contractual relationship with the MAH and is not considered a potential source of safety information and therefore would not be part of the MAH`s pharmacovigilance system. According to MHRA, a contract or agreement is necessary “to ensure that the activities and services provided by these third parties comply with existing legislation and directives and that all parties understand and formally accept contractual tasks.” Yes, yes.

SDEAs may be requested in the United States for inspection in accordance with EU drug safety legislation and equivalent FDA legislation. They must be drawn up within a specified time frame and, within the EU, they must contain a specific list of key details, for example. B the details of the qualified person, etc.

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