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02/03/2022

Taxes for Parallel trade

1. Dossier taxes

Applications for parallel trade authorisation are subject to taxation from the ANMV. The amount of the tax shall be fixed as follows:

TitleAmount of tax payable for a medicinal productAmount of tax payable for several medicinal products
New applicationEUR 7,500N x EUR 7,500

Références : Articles L. 5141-8 et D. 5141-57 of the Code de la santé publique

2. Annual taxes

A tax is payable annually for each authorisation in effect on January 1st of the taxation year. The amount is calculated on the basis of the declaration of turnover in France in the previous year.

  • march/april: a call for a declaration of annual turnover per marketing authorisation carried out in France in the previous year shall be sent to the holders of those marketing authorisations accompanied by the list of marketing authorisations concerned;
  • end of May: the declaration of turnover per MA shall be returned by the holders;
  • july: an invoice is issued and sent with an annual tax schedule to each holder specifying the amount of tax to be paid. The amount due corresponds to 0.45 % of annual pre-tax turnover. The amount of the annual tax per marketing authorisation is limited to EUR 35,000 and the collection threshold is EUR 100;
  • payment shall be made within two months of the issue of the invoice; otherwise a 10 % increase may be applied.

Références : Articles L. 5141-8 et D. 5141-60 of the Code de la santé publique