The following are the requirements of the Medicines Authority for submission of Renewal applications.

Application form

An application for renewal of a marketing authorisation must be made using the following form:  (EU form, application for renewal of a marketing authorization) 

Renewal applications under the new legislation should consist of the following:

Covering Letter

EU Application Form properly completed and signed.

List of all post-authorisation submissions since authorisation/last renewal;

Follow up measures/specific obligations;

Certificate of compliance with Good Manufacturing Practice (GMP);

Product information-Summary of Product Characteristics (SmPC), leaflet and label, preferably in editable MS Wordİ format;

Quality overview (quality expert statement);

Clinical overview (clinical expert statement); and

Reports of post-marketing experience (PSURs)

The renewal application should be submitted according to the EU-CTD format.

National and MRP Renewal requirements

1. One Hard Copy of Module 1.

2. One Soft Copy of all Modules.