EU compassionate use programmes (CUPs): Regulatory framework and points to consider before CUP implementation

Pharmaceutical Medicine

Volumn 24, Issue 4, 2010, Pages 223-229

  Sou, Hélène ^a  

^a VOISIN CONSULTING LIFE SCIENCES   (France)

Author keywords

European Medicines Agency; Legislation; Pharmaceutical industry; Regulatory process; Research and development

Indexed keywords

BUDGET; CLINICAL PROTOCOL; COMPASSIONATE USE; COST; DRUG INDUSTRY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG USE; EUROPEAN UNION; HEALTH PROGRAM; LEGAL ASPECT; ORGANIZATION; PATIENT CARE; PHYSICIAN; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; ARTICLE; COHORT ANALYSIS; COMPARATIVE STUDY; EUROPEAN MEDICINES AGENCY; FINANCIAL MANAGEMENT; HUMAN; PHARMACOVIGILANCE;

EID: 85083211537     PISSN: 11782595     EISSN: 11791993     Source Type: Journal    
DOI: 10.1007/bf03256820     Document Type: Review

References (6)

1. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67) as amended (consolidated version 30/12/2008) [online]. Available from URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ. do?uri=CONSLEG:2001L0083:20081230:EN:PDF [Accessed 2010 Jul 23]
2. 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 (OJ L 136, 30.4.2004, p. 1) [consolidated version: 20/04/2009; online]. Available from URL: http://ec.europa.eu/health/files/ eudralex/vol-1/reg-2004-726-cons/reg-2004-726-cons-en.pdf [Accessed 2010 Jul 23]
3. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). Guideline on compassionate use of medicinal products, pursuant to article 83 of Regulation (EC) No 726/2004 [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory- and-procedural-guideline/2009/10/WC500004075.pdf [Accessed 2010 Aug 16]
4. European Medicines Agency. Conditions of use conditions for distribution and patients targeted and conditions for safety monitoring adressed to Member States for IV Tamiflu: available for compassionate use [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/Other/2010/05/ WC500090250.pdf [Accessed 2010 Jul 23]
5. European Medicines Agency. Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring adressed to member states for IV Zanamivir available for compassionate use [online]. Available from URL: http://www.ema.europa.eu/docs/en-GB/document-library/Other/2010/02/ WC500074124.pdf [Accessed 2010 Jul 23]
6. VOLUME 9A of the rules governing medicinal products in the European Unionguidelines on pharmacovigilance for medicinal products for human use: version September 2008 [online]. Available from URL: http://ec.europa.eu/health/ files/eudralex/vol-9/pdf/vol9a-09-2008-en.pdf [Accessed 2010 Jul 23]