Regulatory overview - Stable products Background, current state of the art and future challenges

Pharmaceuticals Policy and Law

Volumn 7, Issue , 2005, Pages 151-169

  Silvester, Glenda ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85013598572     PISSN: 13892827     EISSN: 2210495X     Source Type: Journal    
DOI: None     Document Type: Article

References (28)

1. Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma. OJ L181, 28.6.1989, p. 44.
2. 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 L311, 28.11.2004, p. 67. as amended by Directive 2002/98/EC [3], Directive 2003/63/EC [8] and Directives 2004/24/EC and 2004/27/EC of the European Parliament and of the Council (OJ L136, 30.4.2004, p. 85 and OJ L136, 30.4.2004, p. 34, respectively).
3. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. OJ L33, 8.2.2003, p. 30.
4. Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components. OJ L91, 30.3.2004, p. 25.
5. Council recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the EC. OJ L203, 21.7.1998, p. 14.
6. CPMP Position Statement on Non-remunerated and remunerated donors: safety and supply of plasma-derived medicinal products. EMEA/CPMP/BWP/1818/02, 30.5.2002.
7. Contribution to Part II of the structure of the dossier for applications for marketing authorisation - control of starting materials for the production of blood derivatives, EC III/5272/94.
8. Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. OJ L159, 27.6.2003, p. 46.
9. CPMP Guideline on the scientific data requirements for a Plasma Master File (PMF), EMEA/ CPMP/BWP/3794/03, 26 February 2004.
10. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. OJ L262, 14.10.2003, p. 22.
11. Revision of Annex 14 to the EU Guide to Good Manufacturing Practice on the Manufacture of medicinal products derived from human blood and plasma. ENTR/III/5717/99, 31 March 2000.
12. EudraLex. The rules governing medicinal products in the European Union (http://pharmacos.eudra. org/F2/eudralex/index.htm).
13. CPMP Note for Guidance on Plasma-derived medicinal products, CPMP/BWP/269/95 rev. 3, 25 January 2001.
14. CPMP Note for Guidance on Virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses, CPMP/BWP/268/95 revised, 14 February 1996.
15. CPMP Note for Guidance on the Warning on transmissible agents in summary of product characteristics (SPCs) and package leaflets for plasma-derived medicinal products, CPMP/BPWG/ BWP/561/03, 22 October 2003.
16. CHMP Guideline on Assessing the risk for virus transmission - New chapter 6 of the Note for Guidance on Plasma-derived medicinal products, CPMP/BWP/5180/03, 21 October 2004.
17. CHMP Position Statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products, EMEA/CPMP/BWP/2879/02/rev 1, 23 June 2004.
18. CHMP Guideline on the Investigation of manufacturing processes for plasma-derived medicinal products with regard to vCJD risk, CPMP/BWP/5136/03, 21 October 2004.
19. Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. OJ L214, 24.8.1993, p. 1.
20. 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 L136, 30.4.2004, p. 1.
21. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products. OJ L 18, 22.1.2000, p. 1.
22. Commission Regulation (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’. OJ L103, 28.4.2000, p. 5.
23. Communication from the Commission on Regulation (EC) No. 141/2000 on orphan medicinal products (2003/C 178/02), OJ C 178, 29.7.2003, p. 1.
24. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. OJ L 169, 12.7.1993, p. 1.
25. Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma. OJ L 312, 13.12.2000, p. 22.
26. Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC as regards medical devices. OJ L6, 10.1.2002, p. 50.
27. ICH E2E Pharmacovigilance Planning (PVP), Note for Guidance on planning pharmacovigilance activities. CPMP/ICH/5716/03, 1.12.2004.
28. Press release: EMEA and FDA publish implementation plan for confidentiality arrangement. EMEA/93356/2004, 4 October 2004. (http://www.emea.eu.int/pdfs/general/direct/pr/93356en04. pdf)