Section 4: Fees levied in connection with operations carried out by the agency

The amount of the duty provided for in Article L. 5321-3 is set as follows: 1° Under 1° of I : For the analysis of samples and the assessment of the documentation relating to the control protocol submitted by the manufacturer, with a view to the release of batches of immunological medicinal products mentioned in 6° of Article L. 5121-1 : €3,500. For the assessment of the documentation relating to…

I.-The examination by the Agence nationale de sécurité du médicament et des produits de santé of the application for a certificate of good manufacturing practice provided for in Article R. 5131-2 of the Public Health Code gives rise to the prior payment of a fee. II – The amount of the fee provided for in I is set at 1,400 euros per certificate application. III -The Agence nationale de sécurité…