French Public Health Code
In forceThe following shall be determined, as necessary, by decree in the Conseil d'Etat:
1° The conditions under which the additional information provided for in Article 13 of Regulation 2019/6 of 11 December 2018 may be displayed on the immediate packaging or outer packaging of veterinary medicinal products ;
2° The procedures applicable to applications for a marketing authorisation for a veterinary medicinal product and to variations thereto, as well as the conditions for decisions granting, imposing temporary restrictions or specific obligations on, suspending or withdrawing such authorisations, as provided for in Regulation (EU) 2019/6 of 11 December 2018 ;
3° The procedures applicable to applications for registration of the veterinary medicinal products referred to in Article L. 5141-5-1 and the conditions under which decisions subjecting these medicinal products to specific obligations and suspending or withdrawing their registration are taken after they have been placed on the market;
4° The procedures for applying article L. 5141-14-5 ;
5° The procedures for submitting applications to obtain the registration of a homeopathic veterinary medicinal product provided for in Article 86 of Regulation (EU) 2019/6 of 11 December 2018, as well as the conditions under which decisions granting, amending, suspending or withdrawing this registration are taken;
6° The rules applicable to the testing of medicinal products and those applicable to studies on veterinary medicinal products that already have a marketing authorisation;
7° The procedures for submitting applications for temporary authorisations to use a veterinary medicinal product as provided for in Articles 110 and 116 of Regulation (EU) 2019/6 of 11 December 2018, the content of the dossier submitted in support of these applications, and the conditions under which decisions granting, amending, suspending or withdrawing these authorisations are taken ;
8° The rules applicable in the event of a change in the holder of the marketing authorisation for a veterinary medicinal product referred to in Article 5 of Regulation (EU) 2019/6 of 11 December 2018 or the registration of a homeopathic veterinary medicinal product referred to in Article 86 of the same Regulation or the registration of a veterinary medicinal product referred to in Article L. 5141-5-1 ;
9° The conditions to which advertising of veterinary medicinal products is subject and those subject to which advertising of veterinary vaccines to professional breeders is authorised;
10° The rules applicable to the pharmacovigilance of veterinary medicinal products provided for in Articles 73, 76 and 79 of Regulation (EU) 2019/6 of 11 December 2018 and medicinal products for human use used under 3° of Article L. 5143-4 ;
11° (Repealed) ;
12° The procedures for applying this Title in Guadeloupe, French Guiana, Martinique, La Réunion, Mayotte and Saint-Barthélemy and Saint-Martin ;
13° The conditions under which the veterinarians referred to in Article L. 5141-15 may use the veterinary medicinal products referred to in the same Article;
14° The rules of procedure applicable to appeals against decisions taken in application of this Title;
15° (Repealed) ;
16° (Repealed) ;
17° The competent administrative authority referred to in Article L. 5141-14-1, as well as the data covered by the declaration referred to in the same article, the frequency and procedures for their transmission;
18° The restrictions that may be placed on the prescription and supply of certain medicinal products in view of the particular risks they present to public health.
Except in the case mentioned in 12° of this article, the decrees mentioned in the first paragraph are issued after obtaining the opinion of the National Agency for Food, Environmental and Occupational Health Safety.
