The Manufacture of Autogenous Vaccines in France

摘要

The presentation consists of an introduction of the French experience concerning the control of autogenous vaccines: the current and future reflection on the status of these products and the implementation of a legislation intended to define legal bounds for the manufacture and the distribution of these particular medicinal products. In France, autogenous vaccines are not allowed in the human field but can be used in the veterinary field as an answer to specific pathological cases. These products areout of the scope of the European regulations in force relating to veterinary medicinal products (Directive 2001/82/CEE). Currently, French legislation regarding specifically autogenous vaccines comprises only a few points: (i) the current situation of the legislation existing on autogenous vaccines in France; (ii) a comment on the current field situation and (iii) a focus on some aspects of the specificity of these products and (iv) on ways of implementing some of the regulatory requirements.