Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
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S.L. 458.31 · Availability Of Medicinal Products (S.L. 458.31)

S.L. 458.31 Art. 2Scope.

In KraftAmtlicher Text

(1) The primary objective of these regulations is the promotion of public health by ensuring the availability of adequate supplies of medicinal products at a reasonable cost in Government Health Services.

(2) These regulations shall apply where the holder of a marketing authorisation, hereinafter referred to as "the applicant", wishes to apply for the inclusion of a medicinal product on the list of medicinal products covered by the Government Health Services, hereinafter referred to as "the Government Formulary List".

(3) These regulations shall be without any prejudice to the power of the Superintendent of Public Health to:

(a) include any medicinal product in the Government Formulary List;

(b) apply pricing measures to any pending and new applications for the introduction of medicinal products.