European Council waters down European Parliament's drug-regulatory legislation

Lancet

Volumn 362, Issue 9397, 2003, Pages 1688-1689

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

^a MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; CANCER; DEGENERATIVE DISEASE; DIABETES MELLITUS; DRUG APPROVAL; DRUG INDUSTRY; DRUG LEGISLATION; DRUG MARKETING; EUROPE; FINANCIAL MANAGEMENT; HEALTH CARE POLICY; HUMAN; NOTE; PRIORITY JOURNAL;

EID: 0345414674     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(03)14882-9     Document Type: Note

References (10)

1. Amended 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=Political agreement. June 12, 2003: http://register.consilium.eu.int/pdf/en/03/st10/st10449en03.pdf (accessed July 15, 2003).
2. Amended 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=political agreement. June 12, 2003: http://register.consilium.eu.int/pdf/en/03/st10/st10450en03.pdf (accessed July 15, 2003).
3. 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 July 15, 2003).
4. European Parliament legislative resolution on the proposal for a European Parliament and Council regulation laying down Community procedures for the authorisation and directive amending Directive 2001/83/EC on the Community code relating to supervision of medicinal products for human and veterinary use and establishing a use. 2002: 84. http://www3.europarl.eu.int/omk/omnsapir.so/ calendar?APP=PDF&TYPE=PV2&FILE=p0021023EN.pdf&LANGUE=EN (accessed July 15, 2003).
5. 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. Nov 26, 2001: http://pharmacos.eudra.org/F2/ review/doc/finaltext/011126- COM_2001_404-EN.pdf (accessed July 15, 2003).
6. 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. http://pharmacos.eudra.org/F2/review/doc/finaltext/011126-COM_2001_404-EN.pdf (accessed July 15, 2003).
7. Garattini S., Bertele' V. Adjusting Europe's drug regulation to public health needs. Lancet. 358:2001;64-67.
8. Garattini S., Bertele' V., Li Bassi L. Light and shade in proposed revision of EU drug-regulatory legislation. Lancet. 361:2003;635-636.
9. European Generic Medicines Association. EU Health Council increase protection of original brand pharmaceuticals. Press release, June 4, 2003: http://egagenerics.com/facts_figures/press/PR%2003-06- 04%20EU%20Health%20Council.doc (accessed July 15, 2003).
10. ABC News. Senate votes for fast access to drugs. June 19, 2003: http://abcnews.go.com/wire/Politics/ap20030619_1817.html (accessed July 15, 2003).