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Development, marketing and assumption of responsibility of the vaccines in France
The development of the vaccines The evaluation of
a vaccine is identical to that of a drug. The file
includes/understands a chemical, pharmaceutical, and
biological documentation with, if necessary, a viral safety
study, a toxicological and pharmacological documentation, a
clinical documentation. The studies at the man are preceded by a preclinic phase of development including/understanding of the pharmacological and toxicological studies. These studies make it possible to check harmlessness, the immunogenic capacity and the tolerance on various animal species by using the same route of administration as that recommended at the man. As for any proprietary medical product, the development of a vaccine is based on clinical studies which proceed in 3 phases (phases I to III). However, there always does not exist of clear differences between these phases in particular for phases II and III. The pharmacological studies (phases I and II) evaluate in particular the characteristics of the answer immune, the interaction with other vaccines, the relation dose/réponse, the diagram of vaccination. The
immmunogenicity and the tolerance are evaluated during
phases I to III and the protective effectiveness primarily
during phase III. The studies of phase IV are studies
carried out after the marketing of the vaccine.
The marketing authorization
Procedures of recording of the drug
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Centralized procedure
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Procedure of mutual recognition |
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The European regulation relating to the marketing authorization (AMM) for the drugs of human use classifies the vaccines in the immunological drugs according to Council Directive 89/342/CEE of 3 May 1989 widening the field of application of directives 65/65/CEE and 75/319/CEE (OJ n° L142 of May 25, 1989).
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