Initial and Annual Renewal Application and Change Request Form 2025

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Addendum. An addendum is an addition to your medical record information in your own words. It does not delete or change any of the existing information in your record. Your additional statement must be limited to 250 words or less per alleged incomplete or incorrect item.
An Addendum to the Clinical Overview (ACO) is a key document submitted during the renewal of a marketing authorisation for a medicinal product. It critically evaluates all safety and efficacy data gathered since the initial approval or last renewal.
Electronic Application Forms (eAF) The Electronic Application Forms offer a convenient, online alternative to the paper forms.
Addendum to the Clinical Overview (Addendum, AddCO) included in Module 2.5 of the authorisation dossier provides important data on medicinal product safety and efficacy issues consisting the basis of the application for the renewal of the Marketing Authorisation (MA).
In accordance with Article 14 (1-3) of Regulation (EC) No 726/2004, a marketing authorisation (MA) is valid for five years from the date of notification of the Commission Decision to the marketing authorisation holder (MAH), and is renewable upon application by the MAH.
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An addendum is an attachment to a contract that modifies the terms and conditions of the original contract. Addendums are used to efficiently update the terms or conditions of many types of contracts.

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