Abstract
Regulation (EC) 1394/2007 of the European Parliament and the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 allowed the use of non - authorized advanced therapy medicinal products under the certain circumstances. This socalled hospital exemption rule needs to be applied in the each Member State of the European Union individually and for this purpose Member States should provide national procedures and control measures. The aim of this article is to clear up the criteria for hospital exemption listed in Regulation (EC) 1394/2007 and to contrast the difference in implementing hospital exemption rule into national legal regimes on examples of the United Kingdom, Lithuania and Poland.
Keywords: Advanced therapy medicinal product, hospital exemption, regulation.
Current Stem Cell Research & Therapy
Title:Hospital Exemption for Advanced Therapy Medicinal Products: Issue in Application in the European Union Member States
Volume: 12 Issue: 1
Author(s): Tatjana Ivaskiene, Mykolas Mauricas and Justinas Ivaska
Affiliation:
Keywords: Advanced therapy medicinal product, hospital exemption, regulation.
Abstract: Regulation (EC) 1394/2007 of the European Parliament and the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 allowed the use of non - authorized advanced therapy medicinal products under the certain circumstances. This socalled hospital exemption rule needs to be applied in the each Member State of the European Union individually and for this purpose Member States should provide national procedures and control measures. The aim of this article is to clear up the criteria for hospital exemption listed in Regulation (EC) 1394/2007 and to contrast the difference in implementing hospital exemption rule into national legal regimes on examples of the United Kingdom, Lithuania and Poland.
Export Options
About this article
Cite this article as:
Ivaskiene Tatjana, Mauricas Mykolas and Ivaska Justinas, Hospital Exemption for Advanced Therapy Medicinal Products: Issue in Application in the European Union Member States, Current Stem Cell Research & Therapy 2017; 12 (1) . https://dx.doi.org/10.2174/1574888X11666160714114854
DOI https://dx.doi.org/10.2174/1574888X11666160714114854 |
Print ISSN 1574-888X |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-3946 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
- Announcements
Related Articles
-
Mechanism of Action of Novel Glibenclamide Derivatives on Potassium and Calcium Channels for Insulin Secretion
Current Drug Targets Recent Updates on Development of Drug Molecules for Human African Trypanosomiasis
Current Topics in Medicinal Chemistry Multilevel Analysis of Locomotion in Immature Preparations Suggests Innovative Strategies to Reactivate Stepping after Spinal Cord Injury
Current Pharmaceutical Design Effect of Botulinum Toxin on Equinus Foot Deformity in Cerebral Palsy Patients: A Systematic Review and Network Meta-analysis
Current Pharmaceutical Design Diagnosis and Treatment of Common Sleep Disorders in Adolescence
Adolescent Psychiatry Nuclear Architecture and Gene Expression in the Quest for Novel Therapeutics
Current Pharmaceutical Design The Neuronal Cytoskeleton as a Potential Therapeutical Target in Neurodegenerative Diseases and Schizophrenia
Current Drug Targets - CNS & Neurological Disorders Discovery of Novel Compounds Targeting DJ-1 as Neuroprotectants for Parkinson’s Disease by Virtual Screening and In Silico Method
Current Computer-Aided Drug Design Blood-Brain Barrier Changes in High Altitude
CNS & Neurological Disorders - Drug Targets Proteomic Analysis of Phosphorylation in the Brain
Current Proteomics Building A New Treatment For Heart Failure-Transplantation of Induced Pluripotent Stem Cell-derived Cells into the Heart
Current Gene Therapy Cybernetic Principles of Aging and Rejuvenation: The Buffering- Challenging Strategy for Life Extension
Current Aging Science Mechanisms of Neurovascular Dysfunction in Acute Ischemic Brain
Current Medicinal Chemistry Advances in Neuroimaging for HIV-1 Associated Neurological Dysfunction: Clues to the Diagnosis, Pathogenesis and Therapeutic Monitoring
Current HIV Research Anxiolytic-Like Effects of 7H-Benzo[e]perimidin-7-One Derivatives through Elevated Plus-Maze Test in Mice
Current Topics in Medicinal Chemistry Commentary 1 (Research Highlights: Parkinson’s Disease and α-Synuclein: Passing it on)
CNS & Neurological Disorders - Drug Targets Does Calprotectin Represent a Regulatory Factor in Host Defense or a Drug Target in Inflammatory Disease?
Endocrine, Metabolic & Immune Disorders - Drug Targets Non-Demented Individuals with Alzheimer’s Disease Neuropathology: Resistance to Cognitive Decline May Reveal New Treatment Strategies
Current Pharmaceutical Design Contribution of Canalicular Glutathione Efflux to Bile Formation. From Cholestasis Associated Alterations to Pharmacological Intervention to Modify Bile Flow
Current Drug Targets - Immune, Endocrine & Metabolic Disorders The Impact of Hypothermia on the Pharmacokinetics of Drugs Used in Neonates and Young Infants
Current Pharmaceutical Design