French Public Health Code
In forceI. - Substantial changes to the activities authorised in application of this section which relate to: - the preparation of a new pharmaceutical form of an advanced therapy medicinal product prepared on a one-off basis; - the preparation of a new pharmaceutical form of an advanced therapy medicinal product prepared on a one-off basis; - the preparation of a new pharmaceutical form of an advanced therapy medicinal product prepared on a one-off basis:
1° The preparation of a new pharmaceutical form of an advanced therapy medicinal product prepared on an ad hoc basis ;
2° the types of activities authorised
3° Changes to premises affecting the conditions under which activities are carried out;
4° the creation of new premises in which the authorised activities are carried out.
II - The application for authorisation to modify is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by the legal entity requesting this authorisation, and by any means enabling the receipt of this application to be dated.
This application must specify the nature of the change requested.
The application for authorisation of a change is accompanied by a technical file adapted to the type of change requested, the model for which is set by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
In the absence of a complete dossier, the Director General will inform the applicant, by any means which allows the date of receipt to be established, of the information which is missing or incomplete, indicating the time limit for providing it.
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will notify the applicant of his decision within ninety days from the date of receipt of the application accompanied by a complete dossier.
The Director General may request any additional information or carry out an investigation to enable him to reach a decision on the application. The period referred to in the previous paragraph is then suspended from the date on which the Director General of the Agence nationale de sécurité du médicament et des produits de santé notifies this decision until receipt of the information requested or the results of the investigation.
If no decision has been taken by the end of the ninety day period, the application for authorisation to modify will be rejected.
III - Modification of the authorisation does not extend the duration of the authorisation initially granted.
IV - In the event of modification of the initial authorisation, a copy of the modified authorisation is sent by the Director General of the Agence nationale de sécurité du médicament et des produits de santé to the Director General of the Agence de la biomédecine and to the Directors General of the regional health agencies concerned.
