Compassionate use of medicinal products in Europe: Current status and perspectives

Bulletin of the World Health Organization

Volumn 89, Issue 3, 2011, Pages 163-

  Rahbari, Mussa ^a   Rahbari, Nuh N ^b  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG PRESCRIBING; HOSPITAL SECTOR; MEDICINE;

ARTICLE; CHRONIC DISEASE; CLINICAL TRIAL (TOPIC); COMPASSIONATE USE; DRUG MARKETING; DRUG USE; EUROPE; GOVERNMENT REGULATION; HEALTH CARE ACCESS; HEALTH PROGRAM; HUMAN; LEGAL PROCEDURE; PRACTICE GUIDELINE;

COMPASSIONATE USE TRIALS; CRITICAL ILLNESS; EUROPEAN UNION; HUMANS;

EUROPE;

EID: 79952330800     PISSN: 00429686     EISSN: 15640604     Source Type: Journal    
DOI: 10.2471/BLT.10.085712     Document Type: Article

References (8)

1. Regulation (EC) no. 726/2004 of the European Parliament and of the Council (OJ L 136, 30.4.2004). Available from: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2004R0726:20090706:EN:PDF [accessed 20 January 2011].
2. Guideline on compassionate use of medicinal products, pursuant to Article 83 of Regulation (EC) no. 726/2004 (doc ref: EMEA/27170/2006). London: European Medicines Agency; 2007. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004075.pdf [accessed 20 January 2011].
3. Compassionate use. London: European Medicines Agency; 2010. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000293.jsp [accessed 20 January 2011].
4. Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring addressed to member states for Tamiflu IV available for compassionate use. London: European Medicines Agency; 2010. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/01/WC500069899.pdf [accessed 20 January 2011].
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6. Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring addressed to member states for IV Zanamivir available for compassionate use. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/02/WC500074124.pdf [accessed 20 January 2011].
7. Verordnung über das Inverkehrbringen von Arzneimitteln ohne Genehmigung oder ohne Zulassung in Härtefällen (Arzneimittel-Härtefall-Verordnung - AMHV) [Regulating the marketing of drugs without authorization or in cases of hardship]. Berlin: Federal Ministry of Justice; 2010. Available from: http://www.gesetze-im-internet.de/amhv/index.html [accessed 20 January 2011].
8. Compassionate use programmes. Bonn: Bundesinstitut für Arzneimittel und Medizinprodukte; 2011. Available from: http://www.bfarm.de/cln_094/DE/Arzneimittel/1_vorDerZul/compUse/compUse-home.html [accessed 20 January 2011].