title: Minor species/minor indications: legal provisions, definition criteria and policies to be considered.
abstract: 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for major species/indications only; (c) an authorized vaccine exists in another Member State and (d) a vaccine has been withdrawn.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.
authors.affiliation: Department of Microbiology and Infectious Diseases, Faculty of Veterinary Medicine, Aristotle University, Thessaloniki, Greece. orestisp@vet.auth.gr
authors.forename: O
authors.initials: O
authors.lastname: Papadopoulos
mesh_terms: D000818:Animals; D004345:Drug Industry / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006115:Greece; D006801:Humans; D011640:Public Policy; D013045:Species Specificity; D014612:Vaccines; D014730:Veterinary Medicine
chemical_list: D014612:Vaccines