Renewal of Marketing Authorizations in EU – Regulatory Week

Posted on

May 9, 2013 | By Márcio Barra

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It’s the fourth day of regulatory week! This means a new regulatory affairs themed short article! Today, how do Marketing Authorization’s renewals work in Europe. If you like this article, please share it!

Renewal of Marketing Authorizations in EU

Marketing authorizations in Europe are valid for five years from the date of notification of the Commission Decision to the marketing authorization holder, and may be renewed on the basis of a re-evaluation of the risk-benefit evaluation balance according to Regulation (EC) 726/2004(1).The application for renewal of a MA must be sent to the appropriate competent authority at least 9 months before the expiration date(1).

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