European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines. Revised topics are marked ‘New’ or ‘Rev. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined biostatistics questions and answers pdf the relevant sections of the text.
How long is my marketing authorisation valid? 2004 are also valid for 5 years. 2004 do not fall under the above provisions. They are valid for 1 year and should therefore be renewed annually.
When shall I submit my renewal application? A renewal application should be submitted to the Agency at the latest 9 months before the expiry date of the MA. A renewal application should also be submitted for suspended MA. If a MAH does not submit the renewal application, the MA will expire on the last day of its validity. The MA validity period is calculated from the date of notification of the Commission Decision to the MAH. The renewal application must be submitted at least 9 months before the MA expiry date.
CHMP assessment process can take up to 120 days of active time. In addition, as the quality of the renewal application is key to ensure a timely start and finalisation of the procedure, a dialogue between MAHs and the Agency will be promoted, for a pre-renewal data-check, approximately one year in advance of MA expiry. How shall I present my renewal application? MAH contact with the EMA. The MAH should complete and sign the renewal application form, appending a list of all authorised strengths, pharmaceutical forms and presentations of the product concerned for which renewal is sought.
Renewal application is not an opportunity to notify the Agency of changes in contact persons. These changes should be notified as per Q. EEA competent authority or MRA partner authority. A reference to the Community EudraGMP database, if available will suffice. EC, manufacturing authorisation holders are required to use as starting materials only active substances which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials as adopted by the Community. This document is needed for the QRD review of the Product Information.
If changes to the PI are proposed as part of the Renewal dossier, a version of the PI in English, highlighting the changes proposed by the MAH should be provided in Word format. When do I have to submit revised product information? An RMP is not systematically required as part of the renewal application. Where the MAH considers that no update to the RMP needs to be implemented, no RMP should be included in section 1.
2 of the Renewal dossier. In this case, the MAH should specify this in the cover letter and provide a declaration in the clinical overview, confirming that the current approved RMP remains unchanged and applicable. Alternatively, if applicable, the MAH can state that an RMP update is being assessed in a procedure ongoing in parallel and no additional RMP changes are considered warranted. If an update of the RMP is proposed by the MAH with the Renewal application, section 1. In this case, in addition, a version of the RMP, highlighting the changes proposed by the MAH should be provided in Word format.