Magisterial hospital preparations – hospital exemptions

Published by IRDiRC

Regulatory AffairsEarly Access SupportAdvanced TherapyHospital ExemptionATMPs

Article 28 of the ATMP Regulation also empowers Member States to permit the manufacturing and use of certain non- routine produced advanced therapies that have not been authorised by the Commission under certain conditions (so-called “Hospital Exemption”) outside the scope of the Medicinal Product Directive 2001/23.

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