Key Benefits:
Decision of 5 April 2012 of the Director
National Veterinary Drugs Agency
In view of the fifth part, Book I of the Public Health Code, including articles L. 5141-6, R. 5141-42 and R. 5141-44;
In light of Decision No. 2010-09-056 of 9 September 2010 on delegation of authority from the Director General of the National Health Safety Agency for Food, Environment and Labour to the Director of the National Veterinary Drugs Agency;
Having regard to the marketing authorization decision (AMM) granted on 27 October 1981 to the veterinary drug known as COLLIER ANTIPARASITAIRE CANYS CHIEN, necklace, from the ADAM laboratory, Les Flots Bleus, 16, rue du Gabian, 98000 Monaco;
See?Order No. 2001-378 of 2 May 2001 which has transposed the guidelines on veterinary drugs with regard to the detailed delivery of certain veterinary pest control drugs;
Considering the reassessment of the safety of the user conducted by the VAN on active substances contained in external pest control veterinary drugs for pets;
In view of the mail sent to the ADAM laboratory on October 28, 2010, indicating that there was a risk to the user and asking for studies to demonstrate the safety of the drug to the user;
Considering the absence of a study;
Having been notified to the ADAM laboratory on 3 February 2012;
Considering the ADAM laboratory's response of 21 February 2012 referring to the similar MMA of another licensee without providing new elements;
Based on the advice of the National Commission on Veterinary Drugs,Article R. 5141-47 of the Public Health Code of 20 March 2012;
Considering therefore that the risk-benefit ratio of the drug COLLIER ANTIPARASITAIRE CANYS CHIEN is considered unfavourable,
The Director of the National Veterinary Drugs Agency decides:
The marketing authorization referred to in article L. 5141-5 and granted on 27 October 1981 to the veterinary drug COLLIER ANTIPARASITAIRE CANYS CHIEN, necklace, from the ADAM laboratory, Les Flots Bleus, 16, rue du Gabian, 98000 Monaco, is removed from the notification of this decision.