French Public Health Code
In forceI.-1. A fee relating to the veterinary medicinal products mentioned in this Title shall be levied by the National Agency for Food, Environmental and Occupational Health Safety, within the limit of the ceiling provided for in I of Article 46 of Law No 2011-1977 of 28 December 2011 on finance for 2012, on each:
1° Application for marketing authorisation for a veterinary medicinal product;
2° Application for modification of a marketing authorisation requiring assessment;
3° Application for temporary authorisation for use of a veterinary medicinal product;
4° Application for authorisation for parallel trade;
5° Application for prior advertising authorisation;
6° Advertising declaration;
7° Issue of an export certificate by the Director General of the Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail;
8° Application for registration of veterinary medicinal products.
2. The fee is payable by the applicant or declarant.
3. The rate of the tax referred to in 1 is set by decree up to a ceiling of 50,000 euros.
The decree mentioned in the first paragraph of this 3 may determine a maximum amount applicable to certain applications grouping together several medicinal products.
4. Those liable for payment are required to pay the amount of the tax mentioned in 1 at the time of submission of each type of application or declaration.
II.-1. The Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail (French National Agency for Food, Environmental and Occupational Health Safety) collects an annual fee for each:
1° Marketing authorisation for a veterinary medicinal product;
2° Temporary authorisation for use of a veterinary medicinal product;
3° Authorisation mentioned in Chapter II of this Title;
4° Declaration of facilities carrying out the non-clinical trials mentioned in Article L. 5141-4;
5° Registration of veterinary medicinal products;
6° Parallel trade authorisation.
2. The tax is payable by the beneficiary of the authorisation, declaration or registration.
3. The rate of the tax referred to in 1 is set by decree, subject to a ceiling of 50,000 euros.
4. The tax referred to in 1 is payable each year on the basis of the number of authorisations, declarations or registrations valid on 1st January of the tax year. It is payable two months after the date of issue of the corresponding revenue order.
In the absence of payment within the time limit set, the unpaid portion of the tax is increased by 10%.
III - The tax mentioned in I and the tax and surcharge mentioned in II are collected by the accounting officer of the Agence nationale chargée de la sécurité sanitaire de l'alimentation, de l'environnement et du travail in accordance with the procedures laid down for the collection of debts owed by public administrative establishments of the State.
IV - The annual coefficient for the revaluation of the taxes mentioned in I and II of this article, with the exception of that provided for in 1° of II, is set, on 1st October of each year, in accordance with the forecast annual average change in consumer prices excluding tobacco provided for the year in question in the economic, social and financial report appended to the Finance Bill.
The amount is rounded up to the nearest euro.
