An assessment of the hospital exemption landscape across European Member States: regulatory frameworks, use and impact

Author:

Hills Allison,Awigena-Cook Jacquelyn,Genenz Ken,Ostertag Mareike,Butler Simon,Eggimann Anne-Virginie,Hubert Annie

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics (clinical),Oncology,Immunology,Immunology and Allergy

Reference63 articles.

1. REGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 Laying down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency. 2004.

2. REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on Advanced Therapy Medicinal Products and Amending Directive 2001/83/EC and Regulation (EC) No 726/2004. 2007.

3. EuropaBio. EuropaBio Position on Advanced Therapy Medicinal Products. https://ec.europa.eu/health/sites/health/files/files/advtherapies/2013_05_pc_atmp/19_pc_atmp_2013.pdf; 2013.

4. Alliance for Regenerative Medicine. Position on Hospital Exemption; 2017. Available at https://alliancerm.org/wp-content/uploads/2018/03/ARM_position_on_HE_final.pdf

5. European Biopharmaceutical Enterprises. EBE Position Paper on the Hospital Exemption; 2017. Available at https://www.ebe-biopharma.eu/wp-content/uploads/2017/10/2017-10-10-EBE-EFPIA-Position-Paper-on-HE-FINAL.pdf

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