Minor Species/Minor Indications: Legal Provisions, Definition Criteria and Policies to Be Considered

摘要

The problem of availability of immunological products in minor species and minor indications/uses is complex and should be well defined. Data for species are available, but not for minor uses. "Case-by-case" decisions should be avoided, as far as possible. The following categories can be recognized: (a) a vaccine has not been authorized anywhere; (b) a vaccine is authorized for major species/indications only; (c) an authorized vaccine exists in another Member State and (d) a vaccine has been withdrawn. Old, well established products, with limited data for an updated dossier could be the problem in categories "c" and "d". Proposed measures and incentives include: "cascade" (not recommended), human orphan-like drug policy, provisional authorization, acceptance of bibliographical data (if justified), procedural and financial assistance. Standards of quality, safety and efficacy cannot be minimized, but specific tests can be considered.