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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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Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)

Published by Official Journal of the European Union

Data ProtectionProcessing of Personal Data

The protection of natural persons in relation to the processing of personal data is a fundamental right. This Regulation is intended to contribute to the accomplishment of an area of freedom, security and justice and of an economic union, to economic and social progress, to the strengthening and the convergence of the economies within the internal market, and to the well-being of natural persons.

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