Article R5138-9 of the French Public Health Code
November 1, 2023
Exceptionally and where necessary, in order to ensure the availability of medicinal products, where a manufacturing establishment of an active substance intended for export and located in a third country has been inspected by a Member State and found to comply with the principles and guidelines of good manufacturing practice, the requirement referred to in Article R. 5138-7 may be waived for a period not exceeding the validity of the…
