When can an unauthorised medicinal product be used?
a)
Pursuant to Section 8, paragraph 3 (b) (2) of the Act on Pharmaceuticals, unauthorised advanced-therapy medicinal products (only somatic cell therapy or tissue engineering medicinal products) may be used for a patient on the basis of the decision of a medicinal doctor, at the responsibility of the respective healthcare service provider (healthcare facility).
b)
Pursuant to Section 49 of the Act on Pharmaceuticals within the scope of specific therapeutic programmes (including special therapeutic programmes).
c)
Where a Hospital Exemption has been allowed pursuant to Section 49a and 49b of the Act on Pharmaceuticals (this only applies to advanced-therapy medicinal products).
d)
In clinical trials approved by the State Institute for Drug Control and the Ethic Committees, pursuant to Sections 50-59 of the Act on Pharmaceuticals.
Act No. 378/2007 Coll., on pharmaceuticals and on amendments to some related acts /Act on Pharmaceuticals, as amended (hereinafter referred to as the “Act on Pharmaceuticals”)
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