Fees for marketing authorisations and variations
- Dossier fees
Applications for marketing authorisations, and for variations and transfers concerning these authorisationsrequire fees to be paid to the ANMV. The amount varies according to the type of application, type of procedure and number of veterinary medicinal products concerned.
- Read the document on MA fees(pdf).
- Annual fees
An annual fee is payable for each valid authorisation at the beginning of the assessment year. The amount is calculated on the basis of the declared turnover in France for the previous year.
- March/April: the MA holders are sent a list of the MAs concerned, and asked to declare the annual turnover in France for the previous year for each product;
- Late May: the declared turnover for each product is sent back by the holders;
- July: an invoice is issued and sent to each holder with an annual fee statement specifying the amount payable. The amount due corresponds to 0.4% of the annual turnover excluding tax. The amount of the annual fee per marketing authorisation is limited to €25,000 and the collection threshold is set at €100.
- Payment has to be made within two months of the invoice issuing date, otherwise the amount may be increased by 10%.