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EMA has cut immediate EudraVigilance "Article 57" workload by 70%

Richard Staines

APM Health Europe

10 February 2012


PA is quoted in an article in APM Health Europe. Following PA Consulting Group’s EudraVigilance Medical Product Dictionary webinar, PA comments on the pharmacovigilance directive and how data should comply with ISO standards.

Commenting on the new legislation,PA says: “Preparation was key to complying with the legislation.”

“Large generic companies will have a large workload because of their wide product range. Generics companies will require information from the original license holder and are more sensitive to costs incurred because of their smaller margins.”

PA explains the need for testing and regulation: "All pharma companies should run a pilot with a complex product and a simple product and test with the EMA early.

"It is currently unclear what penalties the EMA will impose, but they have stated that they will not be policing initially, especially if there are technical delays."

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