Legislative Decree No. 71 implementing Directives 2000/37/EC and 2001/82/EC concerning veterinary medicinal products.

In implementation of particular provisions laid down in Directives 2000/37/EC and 2001/82/EC, this Legislative Decree amends and supplements Legislative Decree No. 119 of 1992 in matter of veterinary drugs. Chapter IV bis shall be inserted after Chapter IV. The new provisions regard the Advisory Commission on Veterinary Drugs, which shall operate under the Ministry of Health. Further, article 26 bis shall be replaced by the text contained in article 3 hereto dealing with the national pharmacovigilance system, which is charged with the collection and valuation, on a scientific basis, of all relevant information. On the other hand, the Regions as well as the Autonomous Provinces shall contribute to the pharmacovigilance system either by setting up their own regional pharmacovigilance centres or by entrusting the competences in question to the regional veterinary services. The Annex attached contains the model of the form to be filled in and submitted to the competent authorities in case any adverse reaction occurs.