Legislator Case Law & Legislation
042/09 AI generated

Supreme Administrative Court dismisses review appeal regarding market authorization of a drug, ruling it is a matter of fact.

Case Number 042/09
Court / Authority
Jurisdiction Portugal (PT)
Decision Date
Outcome Dismissed

Legislator summary

AI generated

The Supreme Administrative Court dismissed the review appeal filed by INFARMED against the decision of the Administrative Tribunal of Commerce (TCA) regarding the market authorization of a medication. The court held that the TCA's assessment of damages and the balancing of interests constitutes a matter of fact, which falls outside the scope of review under Article 150(4) of the Administrative Procedure Code. Consequently, the court determined that the review appeal was inadmissible because the TCA's factual findings are not subject to judicial review in this context.

Legislator headnote

Official

RECURSO DE REVISTA PRESSUPOSTOS

Keywords

AI generated
market authorization matter of fact review appeal administrative procedure judicial review drug regulation inadmissible appeal

Cited Legislation

AI generated
Art. 150(4) n.º 2 CPTA
Art. 120(2) CPTA
artigo 150º do CPTA

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Full text

[Nº CONVENCIONAL] JSTA000P10034

[Nº DO DOCUMENTO] SA120090129042

[RECORRENTE] INFARMED - AUTORIDADE NACIONAL DO MEDICAMENTO E PRODUTOS DE SAÚDE IP

[RECORRIDO 1] MECON

[URL] https://www.dgsi.pt/jsta.nsf/35fbbbf22e1bb1e680256f8e003ea931/E437A6FCFE2D0D2780257553005AD15C?OpenDocument

SUMÁRIO

Constitui matéria de facto de que o STA não conhece em recurso de revista, fora das situações tipificadas na 2ª parte do nº 4, do artigo 150º do CPTA, o juízo feito pelo TCA, quanto à existência de prejuízos e à ponderação de interesses a que alude o nº 2, do artigo 120º do citado Diploma a respeito da autorização de introdução no mercado (AIM) de um medicamento.