Renewal of the Marketing Authorisation

The CMDh Best Practice Guide on the processing of renewals as of September 2012 provides guidance on the preparation and submission of a consolidated version of the file for the marketing authorisation renewal with respect of quality, safety and efficacy, PSUR data and any relevant new information affecting the benefit-risk balance of the product including all variations since the marketing authorisation was granted. The renewal application for marketing authorisation after 5 years should be submitted not later than 9 months before marketing authorisation expiry date.

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We support you in planning, compiling and submitting the renewal application in time and ensure that your renewal conforms to the current requirements and includes pertinent information on quality, clinical and pre-clinical data, relevant literature and exposure data. Renewal applications follow a modular structure to enable structured preparation and evaluation:


The Addendum to the Clinical Overview is a central document in the renewal application. It includes a critical discussion of the safety and efficacy data accumulated since the granting of the initial marketing authorisation or the last renewal taking into account submitted PSUR data, suspected ADRs, pharmacovigilance activities and effectiveness of risk minimisation measures contained in the Risk Management Plan. Relevant information in the public domain which may change the benefit-risk evaluation needs to be considered as well. In essence, the Addendum to the Clinical Overview follows the format and content of a PSUR as defined in GVP Module VII.
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