Light and shade in proposed revision of EU drug-regulatory legislation

Lancet

Volumn 361, Issue 9358, 2003, Pages 635-636

  Garattini, Silvio ^a   Bertele', Vittorio ^a   Bassi, Luca Li ^a  

^a MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

CONSUMER; DRUG SURVEILLANCE PROGRAM; HEALTH; INDUSTRY; LAW; NOTE; ORGANIZATION; PRIORITY JOURNAL; PUBLIC HEALTH; RANDOMIZATION; REGULATORY MECHANISM;

EID: 0037460744     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(03)12615-3     Document Type: Note

References (13)

1. European Parliament legislative resolution on the proposal for a European Parliament and Council regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. 2002: 36. http://www3.europarl.eu.int/omk/omnsapir.so/calendar?APP=PDF&TYPE= PV2&FILE=p0021023EN.pdf&LANGUE=EN (accessed Dec 16, 2002).
2. European Parliament legislative resolution on the proposal for a European Parliament and Council directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. 2002: 84. http://www3.europarl.eu.int/omk/omnsapir.so/calendar?APP=PDF&TYPE= PV2&FILE=p0021023EN.pdf&LANGUE=EN (accessed Dec 16, 2002).
3. Commission of the European Communities. Proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. 2001: http://pharmacos.eudra.org/F2/review/doc/finaltext/011126-COM_2001_404-EN.pdf (accessed Dec 16, 2002).
4. Commission of the European Communities. Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. 2001: http://pharmacos.eudra.org/F2/review/doc/finaltext/011126-COM_2001_404-EN.pdf (accessed Dec 16, 2002).
5. Committee on the Environment, Public Health and Consumer Policy. Report on the proposal for a regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. 2002: http://www2.europarl.eu.int/omk/sipade2?PUBREF=-//EP//NONSGML+REPORT+A5- 2002-0330+0+DOC+PDF+V0//EN&L=EN&LEVEL=2&NAV=S&LSTDOC=Y (accessed Dec 16, 2002).
6. Committee on the Environment, Public Health and Consumer Policy. Report on the proposal for a European Parliament and Council directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. 2002: http://www2.europarl.eu.int/omk/sipade2?PUBREF=-//EP//NONSGML+REPORT+A5- 2002-0340+0+DOC+PDF+V0//EN&L=EN&LEVEL=2&NAV=S&LSTDOC=Y (accessed Dec 16, 2002).
7. Rogers A. European Parliament approves pharma law overhaul. Lancet. 360:2002;1397-1398.
8. Europe et médicament: les parlementaires européens ont choisi la santé publique. La Revue Prescrire Nov 1, 2002: http://www.prescrire.org/aLaUne/dossierEuropeParlement.php (accessed Dec 16, 2002).
9. Council regulation (EEC) no 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Off J Eur Comm 1993; no L 214, Aug 24: 1.
10. Ottawa Charter For Health Promotion. First International Conference on Health Promotion, Ottawa, Nov 21, 1986: WHO/HPR/HEP/95.1. http://www.who.int/hpr/archive/docs/ottawa.html (accessed Dec 16, 2002).
11. European Medicines Evaluation Agency. Committee for Proprietary Medicinal Products 15-17 October plenary meeting: monthly report. 2002: http://www.emea.eu.int/pdfs/human/press/pr/497902en.pdf (accessed Dec 16, 2002).
12. Correa CM. Implications of the Doha Declaration on the TRIPS Agreement and Public Health. WHO/EDM/PAR/2002.3. 2002: http://www.who.int/medicines/library/par/who-edm-par-2002-3/doha- implications.doc (accessed Dec 16, 2002).
13. World Trade Organisation. Ministerial Conference (fourth session, Doha, Nov 9-14, 2001).Doha Ministerial Declaration on the TRIPS Agreement and Public Health. 2001: WT/MIN(01)/DEC/W/2. http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.pdf (accessed Jan 7, 2003).