French General Tax Code
In forceI. - Filing with the agency mentioned in article L. 5311-1 of the Public Health Code of each:
1° Application for registration referred to in articles L. 5121-13 and L. 5121-14 of the same code, of each application for renewal or of each application or notification of modification of this registration;
2° Application for registration mentioned in article L. 5121-14-1 of the same code, each application for renewal or each application or notification of amendment to this registration;
3° Application for marketing authorisation referred to in article L. 5121-8 of the same code or each application for renewal or each application or notification of modification of this authorisation.
Certain minor variations of type IA mentioned in Article 2 of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products relating to information of an administrative or technical nature which does not require scientific expertise are not subject to payment of the fee. A decree of the Conseil d'Etat shall determine the list;
4° Application for recognition by at least one other Member State of the European Union or party to the Agreement on the European Economic Area of a marketing authorisation, issued by the Director General of the Agency mentioned in Article L. 5311-1, mentioned in Article L. 5121-8 of the same code or of each application or notification for modification of this authorisation.
Certain minor variations of type IA mentioned in Article 2 of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products relating to information of an administrative and technical nature and not requiring scientific expertise are not subject to payment of the fee. A decree of the Conseil d'Etat sets the list;
5° Application for a parallel import authorisation in accordance with Article L. 5124-13 of the same code and of each application for amendment or renewal of this authorisation;
6° Application for a visa or renewal of an advertising visa, referred to in articles L. 5122-8 and L. 5122-9 of the same code;
7° Application for authorisation or renewal of authorisation for advertising, referred to in articles L. 5213-4 and L. 5223-3 du même code.
II. - The amount of duty due in respect of the deposits mentioned in I is set by decree up to a maximum limit of:
a) €7,600 for applications mentioned in 1° of I;
b) €21,000 for applications mentioned in 2° of I;
c) €60,000 for applications mentioned in the first paragraph of 3°, 4° and 5° of I;
d) €1,200 for applications mentioned in 6° and 7° of I.
III. - The fee is paid by bank transfer. It is accompanied by a declaration, the model for which is set by the administration. The duty is collected and audited in accordance with the same guarantees and penalties as for registration duties. The administration certifies the payment. If the payment certificate is not produced when the application is submitted to the agency, or if the amount paid is insufficient, the application file is deemed to be incomplete.
When the file for an application referred to in I is complete, the fee paid is refundable only up to the fraction of its amount for which the agency has previously established that payment was insufficient.
