Information concerning the implementation date of variations
The Applicants are kindly asked to indicate the proposed implementation date on the Application Form.
Please define an exact date or time interval (for example „within 6 months after approval”).
„Next production run / The first production run upon approval” is acceptable if the variation is really going to be implemented with the next batch or the first batch manufactured after approval.
„Next printing” is not accepted.
The batch released by the EU Qualified Person or manufactured within the implementation period can be marketed with a final sample permission.
After the defined implementation date a formal authorization for the deviation must be requested.