Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
LAWxPERT Anmelden Kostenloses Konto

S.L. 458.31 · Availability Of Medicinal Products (S.L. 458.31)

S.L. 458.31 Art. 13Price renegotiation.

In KraftAmtlicher Text

(1) The Minister responsible for health may request that the price being charged by the holder of the marketing authorization be reviewed according to the exigencies of the Government Health Services.

(2) The Minister responsible for health shall furnish the holder of the marketing authorization with adequate information which, in his opinion, justifies the review in the price being charged to the Government Health Services.

(3) The holder of the marketing authorization shall within ninety days from date of request referred to in sub-regulation (2) provide a reasoned decision to the request made by the Minister responsible for health.