Article R1125-12 of the French Public Health Code
November 6, 2023
Any substantial modification requires a new authorisation to be issued under the conditions set out in Article R. 1125-8. If the Director General of the Agence française de sécurité sanitaire does not respond to an application from the sponsor for a substantial amendment, this will be deemed to constitute a refusal of the application on expiry of a period of thirty-five days from receipt of all the information required concerning…
