Key Benefits:
Decision of the Director General of the French Health Security Agency Food (National Veterinary Drug Agency)
In view of the fifth part, book Ier, of the Public Health Code, and in particular Articles L. 5141-6 and R. 5146-37;
In view of the decision to authorise the placing on the market granted on 5 June 1980, the veterinary medicinal product known as Inospray, of the SFAN laboratories;
In view of the opinion of the committee provided for in Article R. 5146-38 of the Public Health Code;
Considering the decision of 16 December 2002 repealing the authorisation to open n ° V 075 /78-2 of 28 July 1983 at SFAN, 13, rue des Rainettes, Ranes, 61150 Elayer;
Considering the absence of manufacturer and operator for the veterinary drug Inospray;
Considering the establishment of AFSSA ANMV, in Date of 8 July 2003, relating to the conditions of operation and manufacture of this veterinary medicinal product;
Considering SFAN's letter of 15 October 2003 concerning a request for a time limit to respond to the formal application of the AFSSA ANMV,
The Director General of the French Food Safety Agency decides:
The marketing authorisation for the veterinary specialty Inospray of the SFAN laboratories is suspended as of November 18, 2003 for a Twelve-month duration.
