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02/03/2022

Taxes for marketing authorisation and marketing variations

1. Dossier taxes

Applications for authorisation to place veterinary medicinal products on the market, to amend and transfer such authorisations and applications for registration of homeopathic veterinary medicinal products are subject to taxation from the ANMV. The amount of the tax varies according to the nature of the application, the type of procedure and the number of medicinal products concerned.

See the MA tax document (pdf) 

Reference: Articles L. 5141-8 and Articles D. 5141-55, D. 5141-55-1 and D. 5141-56 of the Code de la santé publique.

Applications for export licences are subject to a fee from Anses-ANMV. The amount of the fee for a licence application shall be EUR 100 per application. An application concerns a medicinal product for a type of certificate

References: Articles L. 5141-8 and D. 5141-58 of the Code de la santé publique.

2. Annual taxes

A tax shall be payable annually for each marketing authorisation, temporary authorisation for the use of a veterinary medicinal product and registration of a homeopathic veterinary medicinal product in force at the beginning 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.

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