ARG/316
WTO/TBT
AR Argentinien
  • 11 - Medizintechnik
2017-03-21
2017-03-13
Medicinal preparations for human use.
Programa de Acceso Expandido (PAE) (Expanded access programme) (11 pages, in Spanish)

Laboratories authorized by ANMAT to import and/or prepare medicinal preparations may request expanded access programme (PAE) authorization in respect of medicines for groups of patients requiring treatment with medicines not yet marketed in the country.

PAEs will only be authorized where treatment is needed for clinical situations implying a high risk of death or a severe deterioration in quality of life and for which no effective treatment is available in the country.