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03/03/2022

Taxes and fees in the field of veterinary medicinal products

As part of its tasks relating to the assessment and risk management of veterinary medicinal products, Anses collects taxes and fees.

The French Agency for Veterinary Medicinal Products (ANMV) is responsible for the assessment and risk management of veterinary medicinal products within the Anses. Applications for appraisal of a dossier relating to a veterinary medicinal product and those relating to their advertising shall be subject to payment of a tax to the ANMV. In addition, each marketing authorisation holder (MA), in charge of a pharmaceutical establishment or testing facility, is liable to pay a tax each year. The amounts of these taxes are defined in the Public Health Code and presented below. In addition, certain services performed by the ANMV, such as inspections abroad, the generation of certified copies of decisions or official  batch release, are subject to a fee.

Law n°2021-1900 of 30 December 2021 on finance for 2022 introduces a revaluation of taxes each year in October (see amended Article L.5141-8 (IV) of the Code de la santé publique).This revaluation is based on the projected annual average change in consumer prices excluding tobacco, foreseen for the year in question, in the economic, social and financial report annexed to the draft finance law.

Following the submission of a file or a request for services, the applicant receives an invoice from the ANMV, the amount of which must be paid to the accounting officer of the Anses. The collection of fees levied on the submission of marketing authorisation or variation applications shall be carried out on a monthly basis.

Payment shall be made after submission, upon receipt of an invoice, which shall be sent periodically to each applicant, accompanied by supporting vouchers including all applications submitted in the previous month. Payment by cheque or transfer is made at one time, upon receipt of this notice.

Références : Article L. 5141-8 of the Public Health Code et Decree No 2021-1859 of 28 December 2021 adopted for the application of Article L. 5141-8 of the Code de la santé publique