Safety Data Exchange Agreement Deutsch
The main objective of the pharmacovigilance agreement is to define a mechanism to ensure the flow of customer safety information to the relevant authorities via mah. In order to achieve this objective, it is the responsibility of the POC to assess trade agreements and determine whether the terms relating to counterparty PV obligations are sufficient to ensure the proper execution of activities. On the basis of this assessment, it is necessary, if necessary, to establish an autonomous agreement on the routes for which the duration of the last batch of the affected products put on the market should be very late. Nor should this period of effect be met at the end of the trade agreement concerned. A security data exchange contract is a legal written contract that ensures that all drug safety data is recovered quickly and reliably from the market authorization holder so that they can meet their legal obligations. A well-developed agreement ensures compliance with the legislation and prevents the doubling of pharmacovigilance activities by different partners. In addition, there must be a follow-up of companies that violate agreements by sending late reports or by not sending any reports. How to identify a company that is remote and does not send serious adverse events is another sensitive topic and involves collaboration with quality and auditing groups of companies. #PVA #SDEA #agreements #contracts #pharmacovigilance #drugsafety In general, counterparties` pharmacovigilance obligations are limited to a limited number of clauses in framework contracts because of the completeness of the terms and conditions. It is the responsibility of the local representative of PHARMACOVIGILANCE (QPPV) to ensure that the pharmacovigilance obligations are clearly defined for both parties. In an organized setting, this responsibility is assigned to a dedicated POC role for the APV/SDEA. The inflow and management of this security information is governed by security data exchange agreements (ADSs) and is a legal requirement in all cases where security data can be received by third parties, not by the licensee.
Security Data Exchange Agreements (ADSs) are legal contracts that ensure that all security data relating to a licensed product is promptly and reliably returned to the holder of the Marketing Authorization (MAH) so that they can meet their legal obligations to aggregate security data and security reporting in a timely manner. Companies must have security exchange agreements in order to fully comply with the rules. There are specific considerations to be made depending on the uniqueness of the business relationship that the partners could maintain. To list a few, there could be a scenario whereby there is a „zero VPA” for the business relationship that does not justify sharing security information. In such cases, POC cannot ignore the full mention of the clause; on the contrary, it should be clearly justified in the trade agreement and/or stand-alone VPA clause (sometimes for other activities). Sometimes the original owner of the product has to take a step backwards because of his own restrictions or regulatory constraints in that particular area to get the MA in his own name. In such scenarios, the MAH would be in the name of the counterparty, which would act as the face of the product only when it comes to submitting legislation and all other activities are carried out by the former party. This situation is delicate and should not be confused with a scenario for regular service providers.
Other specific considerations include merger/transfer and piggyback scenarios, which must be treated with the utmost care, taking into account all factors of influence.