Orphan dugs in EU

Acta Facultatis Pharmaceuticae Universitatis Comenianae

Volumn 60, Issue SUPPL. 8, 2013, Pages 26-31

  Foltanova T ^a   Mazag M ^b  

^a Faculty of Natural Sciences   (Slovakia)

^b State Institute of Drug Control   (Slovakia)

Author keywords

European orphan medicinal product (OMP) regulation; orphan drugs; policy in the field of orphan drugs

Indexed keywords

EID: 84890730171     PISSN: 03012298     EISSN: 13386786     Source Type: Journal    
DOI: 10.2478/afpuc-2013-0005     Document Type: Review

References (6)

1. Regulation (EC) No 141/2000 of the European parliament and of the council. Off J Eur Commun, 2000, 43, L18:1-5.
2. Regulation (EC) No 847/2000, Off J Eur Commun, 43, 2000, L103, p. 5-8. European Commission guideline ENTR/6283/00. (http://www.ema.europa.eu/ema/index. jsp?curl=/pages/medicines/landing/epar-search.jsp&mid=WC0b01ac058001d124). Accessed February 20 2013.
3. Guideline on Clinical Trials in Small Populations. (http://www.ema. europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003615. pdf). Accessed February 20 2013.
4. Commission Regulation (EC) No 2049/2005. (http://ec.europa.eu/health/ files/eudralex/vol-/reg-2005-2049/reg-2005-2049-en.pdf) Accessed February 20 2013.
5. Rare Diseases: Europe's Challenges. (http://ec.europa.eu/health/ph- threats/non-com/docs/rare-com-en.pdf). Accessed February 20 2013.
6. The Council Recommendation on a European Action in the Field of Rare Diseases, adopted by the Health Council on 9 June 2009. (http://eurlex.europa. eu/LexUriServ/LexUriServ.do?uri=OJ:C:2009:151:0007:0010:EN:PDF) Accessed February 20 2013.