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01 March 2012
AEMPS: Instructions for filing of translations of new registrations, renewals and variations in the procedures of mutual recognition and decentralized
After completion of the European phase, the Authorisation Holder Marketing (hereinafter TAC) will send a proposed translation of texts in the following periods:
New registrations and renewals: 5 calendar days.
Variations: 7 days.
For Type IB variations, the proposed translation will be sent with the initial application. However, once the European phase, and whether or not there has been changes from the original proposal, it will take a new shipment Nees with the proposed texts will be considered final unless the Competent Authority to propose changes thereof, which shall require a final shipment, as described in "texting final agreed with the Competent Authority."
This shipment will be made electronically (through RAEFAR) or face (on CD). Do not send proposals by email, to promote the upgrade of the electronic file and direct access of all evaluators of the Competent Authority to the information. Both the proposed translations as final texts agreed with regulatory agencies should be handled outside the eCTD to not affect the life cycle / eCTD numbering sequences at European level. For this reason, the sending of the draft texts will always Nees sequence regardless of the medication record was submitted in eCTD or NEES.
Example numbering sequences proposed sending texts:
What to report?
Record e-CTD: sequence Nees 9000
Nees File: Proposed Sequence translations Nees 9000
E-CTD dossier Nees: Nees be sent the appropriate sequence depending on the number of previous deliveries (consecutive numbering of the numbered items above 9XXX).
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